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The effects of an emotional intelligence program on the quality of life and well-being of patients with type 2 diabetes mellitus.

Purpose: The purpose of the study is to investigate the effect of an emotional intelligence program on the health-related quality of life and well-being of individuals with type 2 diabetes. Methods: The BarOn Emotional Intelligence Scale (EQ-I), WHO Well-Being Questionnaire (WHO-WBQ-22), WHO Quality of Life Measure (WHOQOL-Bref), and the Medical Outcomes Study 36-Item Health Survey (SF-36) were administered to 184 patients with type 2 diabetes who volunteered to participate. Thirty-six patients with the lowest test scores on the WHO-WBQ-22, WHOQOL-Bref, and SF-36 were randomized into study and control groups (18 patients each). A 12-week emotional intelligence program was administered to the study group. At the end of the program, scales were readministered to both groups and again at 3 and 6 months. Results: There were no differences between the quality of life, well-being, and emotional intelligence levels of the study and control groups before the commencement of the program (P > .05). At the conclusion of the program, quality of life, well-being, and emotional intelligence levels of study group patients increased in comparison with those in the control group (P < .001). The positive effect of the program on study groups' quality of life, wellbeing, and emotional intelligence persisted at the 3- and 6-month follow-up. Conclusion: The emotional intelligence program may have positive effects on quality of life and well-being of individuals with type 2 diabetes.

The Diabetes educator · randomised controlled trial · 39 citationsread the source →

Health-related characteristics and unmet needs of men with erectile dysfunction: a survey in five European countries.

Introduction: Data suggest that ED is still an underdiagnosed and undertreated condition. In addition, it seems that men with ED are unsatisfied about their relationship with their physician and with the available drugs. Aim: The study aims to identify health-related characteristics and unmet needs of patients suffering from erectile dysfunction (ED) in big 5 European Union (EU) nations (France, Germany, Italy, Spain, and UK). Methods: Data were collected from the 2011 5EU National Health and Wellness-Survey on a population of 28,511 adult men (mean age: 47.18; SD 16.07) and was focused on men (5,184) who self-reported ED in the past 6 months. In addition, the quality of life (QoL) and work productivity/activity were explored. Main outcome measures: Health-related QoL (HRQoL) and work productivity were measured with SF-12v2 and WPAI validated psychometric tools. Results: One in every 20 young men (age 18-39) across 5EU experienced ED in the past 6 months. About half of men (2,702/5,184; [52%]) with ED across all ages did not discuss their condition with their physician. Interestingly, among those men who did discuss their condition with their physician, 68% (1,668/2,465) do not currently use medication. These findings were more evident in the age group of 18-39 years. Only 48% (2,465/5,184) had a closer relationship with their physician, suggesting that this quality of relationship may be unsatisfactory. Compared with controls, ED patients have a significantly higher intrapsychic and relational psychopathological comorbid burden and relevant decreasing in HRQoL, with a significantly higher impairment on work productivity/activity. Conclusion: Data suggest that there is a need for a new therapeutic paradigm in ED treatment which images the achievement of a new alliance between physician and patient. Hence, alternative drug delivery strategies may reduce the psychological and social impact of this disease.

The journal of sexual medicine · 62 citationsread the source →

Verification of 2021 IDF-DAR risk assessment tool for fasting Ramadan in patients with diabetes attending primary health care in The Kingdom of Bahrain: The DAR-BAH study.

Background: There is a high prevalence of diabetes mellitus among Muslim adult patients. Those Muslims are required to fast the holy month of Ramadan. However, the Islam religion exempted some people with medical issues. It was not clear if all the patients with diabetes were considered medically unfit to fast Ramadan. Therefore, IDF-DAR group created a new risk calculator to categorize the patients with diabetes to advise with or against fasting accordingly. Objective: This study is validating the IDF-DAR tool in assessing the accuracy of IDF-DAR risk calculator tool on adult patients with diabetes visiting primary health care in the Kingdom of Bahrain. The study will facilitate the health care professionals' decision to exempt the patients from fasting. Methods: It is a prospective, randomized study for Ramadan 1444/2023 to assess the new IDF-DAR risk score tool that predicts the complications and the negative outcome of fasting during Ramadan. It included pre- and post-Ramadan questionnaires. 757 patients were selected randomly from the patients list of the central diabetes clinics in primary health care for pre-Ramadan risk assessment scoring. Post-Ramadan a phone a questionnaire was done to evaluate the ability of fasting and the occurrence of adverse events. Results: Out of the 757 participants, 611 were included in the study. The mean age of the studied population was 59.8 years and 52.8 % of them were female. 630 (95.3 %) had type 2 diabetes. According to the new IDF-DAR risk calculator, 184 (27.8 %) were categorized as low risk (≤3 score), 252 (38.1 %) as moderate risk (3-6 score), and 225 (34 %) as high risk (>6 score). The percentage of patients completed their 30 days fasting successfully without reporting adverse events in the low, moderate, and high-risk groups were 92.4 %, 89.3 %, 74.7 % respectively. There was significant increased risk in breaking the fast between the low-risk group and high-risk group with a p-value of <0.001. Similarly, there was significant increased risk in breaking the fast between the moderate-risk group and high-risk group with p-value of <0.001. The main reason of breaking the fast was hypoglycemic attacks. The leading factors that play a significant role in increasing the risk of adverse events during fasting Ramadan were type 1 diabetes mellitus, the presence of previous hypoglycemia attacks, the presence of renal impairment, and negative previous Ramadan experience. Conclusion: The new IDF-DAR risk calculator is a good tool to predict both the ability to fast Ramadan and the probability of experiencing adverse events (mainly hypoglycemia) in people with diabetes mellitus in Kingdom of Bahrain.

Diabetes research and clinical practice · randomised controlled trial · 14 citationsread the source →

Fish Intake in Pregnancy and Child Growth: A Pooled Analysis of 15 European and US Birth Cohorts.

Importance: Maternal fish intake in pregnancy has been shown to influence fetal growth. The extent to which fish intake affects childhood growth and obesity remains unclear. Objective: To examine whether fish intake in pregnancy is associated with offspring growth and the risk of childhood overweight and obesity. Design, setting, and participants: Multicenter, population-based birth cohort study of singleton deliveries from 1996 to 2011 in Belgium, France, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Spain, and Massachusetts. A total of 26,184 pregnant women and their children were followed up at 2-year intervals until the age of 6 years. Exposures: Consumption of fish during pregnancy. Main outcomes and measures: We estimated offspring body mass index percentile trajectories from 3 months after birth to 6 years of age. We defined rapid infant growth as a weight gain z score greater than 0.67 from birth to 2 years and childhood overweight/obesity at 4 and 6 years as body mass index in the 85th percentile or higher for age and sex. We calculated cohort-specific effect estimates and combined them by random-effects meta-analysis. Results: This multicenter, population-based birth cohort study included the 26,184 pregnant women and their children. The median fish intake during pregnancy ranged from 0.5 times/week in Belgium to 4.45 times/week in Spain. Women who ate fish more than 3 times/week during pregnancy gave birth to offspring with higher body mass index values from infancy through middle childhood compared with women with lower fish intake (3 times/week or less). High fish intake during pregnancy (>3 times/week) was associated with increased risk of rapid infant growth, with an adjusted odds ratio (aOR) of 1.22 (95% CI, 1.05-1.42) and increased risk of offspring overweight/obesity at 4 years (aOR, 1.14 [95% CI, 0.99-1.32]) and 6 years (aOR, 1.22 [95% CI, 1.01-1.47]) compared with an intake of once per week or less. Interaction analysis showed that the effect of high fish intake during pregnancy on rapid infant growth was greater among girls (aOR, 1.31 [95% CI, 1.08-1.59]) than among boys (aOR, 1.11 [95% CI, 0.92-1.34]; P = .02 for interaction). Conclusions and relevance: High maternal fish intake during pregnancy was associated with increased risk of rapid growth in infancy and childhood obesity. Our findings are in line with the fish intake limit proposed by the US Food and Drug Administration and Environmental Protection Agency.

JAMA pediatrics · cohort or longitudinal · 40 citationsread the source →

Impact of personality status on the outcomes and cost of cognitive-behavioural therapy for health anxiety.

Background: Health anxiety, hypochondriasis and personality disturbance commonly coexist. The impact of personality status was assessed in a secondary analysis of a randomised controlled trial (RCT). Aims: To test the impact of personality status using ICD-11 criteria on the clinical and cost outcomes of treatment with cognitive-behavioural therapy for health anxiety (CBT-HA) and standard care over 2 years. Method: Personality dysfunction was assessed at baseline in 444 patients before randomisation and independent assessment of costs and outcomes made on four occasions over 2 years. Results: In total, 381 patients (86%) had some personality dysfunction with 184 (41%) satisfying the ICD criteria for personality disorder. Those with no personality dysfunction showed no treatment differences (P = 0.90) and worse social function with CBT-HA compared with standard care (P<0.03) whereas all other personality groups showed greater improvement with CBT-HA maintained over 2 years (P<0.001). Less benefit was shown in those with more severe personality disorder (P<0.05). Costs were less with CBT-HA except for non-significant greater differences in those with moderate or severe personality disorder. Conclusions: The results contradict the hypothesis that personality disorder impairs response to CBT in health anxiety in both the short and medium term.

The British journal of psychiatry : the journal of mental science · randomised controlled trial · 16 citationsread the source →

Antenatal breastfeeding education for increasing breastfeeding duration.

Background: Breast milk is well recognised as the best food source for infants. The impact of antenatal breastfeeding (BF) education on the duration of BF has not been evaluated. Objectives: To assess the effectiveness of antenatal breastfeeding (BF) education for increasing BF initiation and duration. Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register on 1 March 2016, CENTRAL (The Cochrane Library, 2016, Issue 3), MEDLINE (1966 to 1 March 2016) and Scopus (January 1985 to 1 March 2016). We contacted experts and searched reference lists of retrieved articles. Selection criteria: All identified published, unpublished and ongoing randomised controlled trials (RCTs) assessing the effect of formal antenatal BF education or comparing two different methods of formal antenatal BF education, on the duration of BF. We included RCTs that only included antenatal interventions and excluded those that combined antenatal and intrapartum or postpartum BF education components. Cluster-randomised trials were included in this review. Quasi-randomised trials were not eligible for inclusion. Data collection and analysis: We assessed all potential studies identified as a result of the search strategy. Two review authors extracted data from each included study using the agreed form and assessed risk of bias. We resolved discrepancies through discussion. We assessed the quality of the evidence using the GRADE approach. Main results: This review update includes 24 studies (10,056 women). Twenty studies (9789 women) contribute data to analyses. Most studies took place in high-income countries such as the USA, UK, Canada and Australia. In the first five comparisons, we display the included trials according to type of intervention without pooling data. For the 'Summary of findings' we pooled data for a summary effect. Five included studies were cluster-randomised trials: all of these adjusted data and reported adjustments as odds ratios (OR). We have analysed the data using the generic inverse variance method and presented results as odds ratios, because we were unable to derive a cluster-adjusted risk ratio from the published cluster-trial. We acknowledge that the use of odds ratio prevents the pooling of these cluster trials in our main analyses. One method of BF education with standard (routine) careThere were no group differences for duration of any BF in days or weeks. There was no evidence that interventions improved the proportion of women with any BF or exclusive BF at three or six months. Single trials of different interventions were unable to show that education improved initiation of BF, apart from one small trial at high risk of attrition bias. Many trial results marginally favoured the intervention but had wide confidence intervals crossing the line of no effect. BF complications such as mastitis and other BF problems were similar in treatment arms in single trials reporting these outcomes. Multiple methods of BF education versus standard careFor all trials included in this comparison we have presented the cluster-adjusted odds ratios as reported in trial publications. One three-arm study found the intervention of BF booklet plus video plus Lactation Consultant versus standard care improved the proportion of women exclusively BF at three months (OR 2.60, 95% CI 1.25 to 5.40; women = 159) and marginally at six months (OR 2.40, 95% CI 1.00 to 5.76; women = 175). For the same trial, an intervention arm without a lactation consultant but with the BF booklet and video did not have the same effect on proportion of women exclusively BF at three months (OR 1.80, 95% CI 0.80 to 4.05; women = 159) or six months (OR 0.90, 95% CI 0.30 to 2.70; women = 184). One study compared monthly BF sessions and weekly cell phone message versus standard care and reported improvements in the proportion of women exclusively BF at both three and six months (three months OR 1.80, 95% CI 1.10 to 2.95; women = 390; six months OR 2.40, 95% CI 1.40 to 4.11; women = 390). One study found monthly BF sessions and weekly cell phone messages improved initiation of BF over standard care (OR 2.61, 95% CI 1.61 to 4.24; women = 380). BF education session versus standard care, pooled analyses for 'Summary of findings' (SoF)This comparison does not include cluster-randomised trials reporting adjusted odds ratios. We did not downgrade any evidence for trials' lack of blinding; no trial had adequate blinding of staff and participants. The SoF table presents risk ratios for all outcomes analysed. For proportion of women exclusively BF there is no evidence that antenatal BF education improved BF at three months (RR 1.06, 95% CI 0.90 to 1.25; women = 822; studies = 3; moderate quality evidence) or at six months (RR 1.07, 95% CI 0.87 to 1.30; women = 2161; studies = 4; moderate quality evidence). For proportion of women with any BF there were no group differences in BF at three (average RR 0.98, 95% CI 0.82 to 1.18; women = 654; studies = 2; I² = 60%; low-quality evidence) or six months (average RR 1.05, 95% CI 0.90 to 1.23; women = 1636; studies = 4; I² = 61%; high-quality evidence). There was no evidence that antenatal BF education could improve initiation of BF (average RR 1.01, 95% CI 0.94 to 1.09; women = 3505; studies = 8; I² = 69%; high-quality evidence). Where we downgraded evidence this was due to small sample size or wide confidence intervals crossing the line of no effect, or both. There was insufficient data for subgroup analysis of mother's occupation or education. Authors' conclusions: There was no conclusive evidence supporting any antenatal BF education for improving initiation of BF, proportion of women giving any BF or exclusively BF at three or six months or the duration of BF. There is an urgent need to conduct a high-quality, randomised controlled study to evaluate the effectiveness and adverse effects of antenatal BF education, especially in low- and middle-income countries. Evidence in this review is primarily relevant to high-income settings.

The Cochrane database of systematic reviews · meta-analysis · 86 citationsread the source →

Pharmacotherapies for sleep disturbances in dementia.

Background: Sleep disturbances, including reduced nocturnal sleep time, sleep fragmentation, nocturnal wandering, and daytime sleepiness are common clinical problems in dementia, and are associated with significant caregiver distress, increased healthcare costs, and institutionalisation. Drug treatment is often sought to alleviate these problems, but there is significant uncertainty about the efficacy and adverse effects of the various hypnotic drugs in this vulnerable population. Objectives: To assess the effects, including common adverse effects, of any drug treatment versus placebo for sleep disorders in people with dementia, through identification and analysis of all relevant randomised controlled trials (RCTs). Search methods: We searched ALOIS (www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cognitive Improvement Group's Specialized Register, in March 2013 and again in March 2016, using the terms: sleep, insomnia, circadian, hypersomnia, parasomnia, somnolence, rest-activity, sundowning. Selection criteria: We included RCTs that compared a drug with placebo, and that had the primary aim of improving sleep in people with dementia who had an identified sleep disturbance at baseline. Trials could also include non-pharmacological interventions, as long as both drug and placebo groups had the same exposure to them. Data collection and analysis: Two review authors independently extracted data on study design, risk of bias, and results from the included study reports. We obtained additional information from study authors where necessary. We used the mean difference as the measure of treatment effect, and where possible, synthesized results using a fixed-effect model. Main results: We found six RCTs eligible for inclusion for three drugs: melatonin (222 participants, four studies, but only two yielded data on our primary sleep outcomes suitable for meta-analysis), trazodone (30 participants, one study), and ramelteon (74 participants, one study, no peer-reviewed publication, limited information available).The participants in the trazodone study and almost all participants in the melatonin studies had moderate-to-severe dementia due to Alzheimer's disease (AD); those in the ramelteon study had mild-to-moderate AD. Participants had a variety of common sleep problems at baseline. All primary sleep outcomes were measured using actigraphy. In one study of melatonin, drug treatment was combined with morning bright light therapy. Only two studies made a systematic assessment of adverse effects. Overall, the evidence was at low risk of bias, although there were areas of incomplete reporting, some problems with participant attrition, related largely to poor tolerance of actigraphy and technical difficulties, and a high risk of selective reporting in one trial that contributed very few participants. The risk of bias in the ramelteon study was unclear due to incomplete reporting. We found no evidence that melatonin, at doses up to 10 mg, improved any major sleep outcome over 8 to 10 weeks in patients with AD who were identified as having a sleep disturbance. We were able to synthesize data for two of our primary sleep outcomes: total nocturnal sleep time (mean difference (MD) 10.68 minutes, 95% CI -16.22 to 37.59; N = 184; two studies), and the ratio of daytime sleep to night-time sleep (MD -0.13, 95% CI -0.29 to 0.03; N = 184; two studies). From single studies, we found no difference between melatonin and placebo groups for sleep efficiency, time awake after sleep onset, or number of night-time awakenings. From two studies, we found no effect of melatonin on cognition or performance of activities of daily living (ADL). No serious adverse effects of melatonin were reported in the included studies. We considered this evidence to be of low quality. There was low-quality evidence that trazodone 50 mg given at night for two weeks improved total nocturnal sleep time (MD 42.46 minutes, 95% CI 0.9 to 84.0; N = 30; one study), and sleep efficiency (MD 8.53%, 95% CI 1.9 to 15.1; N = 30; one study) in patients with moderate-to-severe AD, but it did not affect the amount of time spent awake after sleep onset (MD -20.41, 95% CI -60.4 to 19.6; N = 30; one study), or the number of nocturnal awakenings (MD -3.71, 95% CI -8.2 to 0.8; N = 30; one study). No effect was seen on daytime sleep, cognition, or ADL. No serious adverse effects of trazodone were reported. Results from a phase 2 trial investigating ramelteon 8 mg administered at night were available in summary form in a sponsor's synopsis. Because the data were from a single, small study and reporting was incomplete, we considered this evidence to be of low quality in general terms. Ramelteon had no effect on total nocturnal sleep time at one week (primary outcome) or eight weeks (end of treatment) in patients with mild-to-moderate AD. The synopsis reported few significant differences from placebo for any sleep, behavioural, or cognitive outcomes; none were likely to be of clinical significance. There were no serious adverse effects from ramelteon. Authors' conclusions: We discovered a distinct lack of evidence to help guide drug treatment of sleep problems in dementia. In particular, we found no RCTs of many drugs that are widely prescribed for sleep problems in dementia, including the benzodiazepine and non-benzodiazepine hypnotics, although there is considerable uncertainty about the balance of benefits and risks associated with these common treatments. From the studies we identified for this review, we found no evidence that melatonin (up to 10mg) helped sleep problems in patients with moderate to severe dementia due to AD. There was some evidence to support the use of a low dose (50 mg) of trazodone, although a larger trial is needed to allow a more definitive conclusion to be reached on the balance of risks and benefits. There was no evidence of any effect of ramelteon on sleep in patients with mild to moderate dementia due to AD. This is an area with a high need for pragmatic trials, particularly of those drugs that are in common clinical use for sleep problems in dementia. Systematic assessment of adverse effects is essential.

The Cochrane database of systematic reviews · meta-analysis · 64 citationsread the source →

Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial.

Importance: Atopic dermatitis is associated with substantial patient and caregiver burden. Currently available treatments for atopic dermatitis are inadequate or contraindicated for some patients. Abrocitinib (PF-04965842) is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of atopic dermatitis. Objective: To investigate the efficacy and safety of abrocitinib for patients with moderate to severe atopic dermatitis. Design, setting, and participants: A phase 2b, randomized, double-blinded, placebo-controlled, parallel-group trial was conducted from April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months. Efficacy was assessed in the full analysis set, which was a modified intention-to-treat population that included all patients who received 1 dose or more of the study drug except for 4 patients from 1 site. Interventions: Participants were randomly assigned 1:1:1:1:1 to receive abrocitinib (200 mg, 100 mg, 30 mg, or 10 mg) or placebo once daily for 12 weeks. Main outcomes and measures: The primary outcome was the proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1) with an improvement from baseline of 2 grades or more at week 12. The secondary outcome was the percentage change from baseline in the Eczema Area and Severity Index at week 12. Results: Of the 267 participants, 144 were women (mean [SD] age, 40.8 [16.1] years). At week 12, 21 of 48 patients receiving 200 mg of abrocitinib (43.8%; P < .001, 2-sided), 16 of 54 patients receiving 100 mg of abrocitinib (29.6%; P < .001), and 3 of 52 patients receiving placebo (5.8%) achieved grades of clear or almost clear on the Investigator's Global Assessment scale with improvement of 2 grades or more; these rates correspond to maximum effect model-based estimates of 44.5% (95% CI, 26.7%-62.3%) for those receiving 200 mg of abrocitinib, 27.8% (95% CI, 14.8%-40.9%) for those receiving 100 mg of abrocitinib, and 6.3% (95% CI, -0.2% to 12.9%) for those receiving placebo. Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%; P = .009) for those receiving 100 mg of abrocitinib, and 35.2% (90% CI, 24.4%-46.1%) for those receiving placebo. Adverse events were observed in 184 of 267 patients (68.9%); the most frequently reported adverse events (in ≥3 patients in any group) were dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea. Dose-dependent decreases in platelet count were observed but trended upward toward baseline levels after week 4. Conclusions and relevance: Once-daily oral abrocitinib was effective and well tolerated for short-term use in adults with moderate to severe atopic dermatitis. Additional trials are necessary to evaluate long-term efficacy and safety. Trial registration: ClinicalTrials.gov identifier: NCT02780167.

JAMA dermatology · randomised controlled trial · 197 citationsread the source →

Clinical Outcomes of Asynchronous Versus Synchronous Telepsychiatry in Primary Care: Randomized Controlled Trial.

Background: Asynchronous telepsychiatry (ATP; delayed-time) consultations are a novel form of psychiatric consultation in primary care settings. Longitudinal studies comparing clinical outcomes for ATP with synchronous telepsychiatry (STP) are lacking. Objective: This study aims to determine the effectiveness of ATP in improving clinical outcomes in English- and Spanish-speaking primary care patients compared with STP, the telepsychiatry usual care method. Methods: Overall, 36 primary care physicians from 3 primary care clinics referred a heterogeneous sample of 401 treatment-seeking adult patients with nonurgent psychiatric disorders. A total of 184 (94 ATP and 90 STP) English- and Spanish-speaking participants (36/184, 19.6% Hispanic) were enrolled and randomized, and 160 (80 ATP and 80 STP) of them completed baseline evaluations. Patients were treated by their primary care physicians using a collaborative care model in consultation with the University of California Davis Health telepsychiatrists, who consulted with patients every 6 months for up to 2 years using ATP or STP. Primary outcomes (the clinician-rated Clinical Global Impressions [CGI] scale and the Global Assessment of Functioning [GAF]) and secondary outcomes (patients' self-reported physical and mental health and depression) outcomes were assessed every 6 months. Results: For clinician-rated primary outcomes, ATP did not promote greater improvement than STP at 6-month follow-up (ATP vs STP, adjusted difference in follow-up at 6 months vs baseline differences for CGI: 0.2, 95% CI -0.2 to 0.6; P=.28; and GAF: -0.6, 95% CI -3.1 to 1.9; P=.66) or 12-month follow-up (ATP vs STP, adjusted difference in follow-up at 12 months vs baseline differences for CGI: 0.4, 95% CI -0.04 to 0.8; P=.07; and GAF: -0.5, 95% CI -3.3 to 2.2; P=.70), but patients in both arms had statistically and clinically significant improvements in both outcomes. There were no significant differences in improvement from baseline between ATP and STP on any patient self-reported ratings at any follow-up (all P values were between .17 and .96). Dropout rates were higher than predicted but similar between the 2 arms. Of those with baseline visits, 46.8% (75/160) did not have a follow-up at 1 year, and 72.7% (107/147) did not have a follow-up at 2 years. No serious adverse events were associated with the intervention. Conclusions: This is the first longitudinal study to demonstrate that ATP can improve clinical outcomes in English- and Spanish-speaking primary care patients. Although we did not find evidence that ATP is superior to STP in improving clinical outcomes, it is potentially a key part of stepped mental health interventions available in primary care. ATP presents a possible solution to the workforce shortage of psychiatrists and a strategy for improving existing systems of care. Trial registration: ClinicalTrials.gov NCT02084979; https://clinicaltrials.gov/ct2/show/NCT02084979.

Journal of medical Internet research · randomised controlled trial · 22 citationsread the source →

Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial.

Background: Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, shows a remarkable ability to lower blood glucose, enabling many patients with long-standing type 2 diabetes to achieve normoglycaemia. We aimed to understand the physiological mechanisms underlying the action of tirzepatide in type 2 diabetes. Methods: This multicentre, randomised, double-blind, parallel-arm, phase 1 study was done at two centres in Germany. Eligible patients were aged 20-74 years, had type 2 diabetes for at least 6 months, and were being treated with lifestyle advice and stable doses of metformin, with or without one additional stable dose of another oral antihyperglycaemic medicine, 3 months before study entry. Via a randomisation table, patients were randomly assigned (3:3:2) to subcutaneously receive either tirzepatide 15 mg, semaglutide 1 mg, or placebo once per week. Endpoint measurements were done at baseline and the last week of therapy (week 28). The primary endpoint was the effect of tirzepatide versus placebo on the change in clamp disposition index (combining measures of insulin secretion and sensitivity) from baseline to week 28 of treatment and was analysed in the pharmacodynamic analysis set, which comprised all randomly assigned participants who received at least one dose of a study drug and had evaluable pharmacodynamic data. Safety was analysed in the safety population, which comprised all randomly assigned participants who received at least one dose of a study drug. Secondary endpoints included the effect of tirzepatide versus semaglutide on the change in clamp disposition index from baseline to week 28 of treatment, glucose control, total insulin secretion rate, M value (insulin sensitivity), and fasting and postprandial glucagon concentrations. Exploratory endpoints included the change in fasting and postprandial insulin concentrations. This study is registered with ClinicalTrials.gov, NCT03951753, and is complete. Findings: Between June 28, 2019, and April 8, 2021, we screened 184 individuals and enrolled 117 participants, all of whom were included in the safety population (45 in the tirzepatide 15 mg group, 44 in the semaglutide 1 mg group, and 28 in the placebo group). Because of discontinuations and exclusions due to missing or unevaluable data, 39 patients in each treatment group and 24 patients in the placebo group comprised the pharmacodynamic analysis set. With tirzepatide, the clamp disposition index increased from a least squares mean of 0·3 pmol m-2 L min-2 kg-1 (SE 0·03) at baseline by 1·9 pmol m-2 L min-2 kg-1 (0·16) to total 2·3 pmol m-2 L min-2 kg-1 (SE 0·16) at week 28 and, with placebo, the clamp disposition index did not change much from baseline (least squares mean at baseline 0·4 pmol m-2 L min-2 kg-1 [SE 0·04]; change from baseline 0·0 pmol m-2 L min-2 kg-1 [0·03]; least squares mean at week 28 0·3 [SE 0·03]; estimated treatment difference [ETD] tirzepatide vs placebo 1·92 [95% CI 1·59-2·24]; p<0·0001). The improvement with tirzepatide in clamp disposition index was significantly greater than with semaglutide (ETD 0·84 pmol m-2 L min-2 kg-1 [95% CI 0·46-1·21]). This result reflected significant improvements in total insulin secretion rate (ETD 102·09 pmol min-1 m-2 [51·84-152·33]) and insulin sensitivity (ETD 1·52 mg min-1 kg-1 [0·53-2·52]) for tirzepatide versus semaglutide. On meal tolerance testing, tirzepatide significantly reduced glucose excursions (lower insulin and glucagon concentrations) compared with placebo, with effects on these variables being greater than with semaglutide. The safety profiles of tirzepatide and semaglutide were similar, with gastrointestinal adverse events being the most common (11 [24%], 13 [30%], and seven [25%] with nausea; nine [20%], 13 [30%], and six [21%] with diarrhoea; and three [7%], five [11%], and one [4%] with vomiting, for tirzepatide, semaglutide, and placebo, respectively). There were no deaths. Interpretation: The glycaemic efficacy of GIP/GLP-1 receptor agonist tirzepatide in type 2 diabetes results from concurrent improvements in key components of diabetes pathophysiology, namely β-cell function, insulin sensitivity, and glucagon secretion. These effects were large and help to explain the remarkable glucose-lowering ability of tirzepatide seen in phase 3 studies. Funding: Eli Lilly.

The lancet. Diabetes & endocrinology · randomised controlled trial · 202 citationsread the source →

Evidence-Based Psychosocial Treatments for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

The purpose of this research was to update the Pelham and Fabiano (2008 Pelham , W. E. , & Fabiano , G. A. ( 2008 ). Evidence-based psychosocial treatments for attention-deficit/hyperactivity disorder . Journal of Clinical Child and Adolescent Psychology , 37 , 184 – 214 .[Taylor & Francis Online], [Web of Science ®] , [Google Scholar]) review of evidence-based practices for children and adolescents with attention-deficit/hyperactivity disorder. We completed a systematic review of the literature published between 2007 and 2013 to establish levels of evidence for psychosocial treatments for these youth. Our review included the identification of relevant articles using criteria established by the Society of Clinical Child and Adolescent Psychology (see Southam-Gerow & Prinstein, in press Southam-Gerow , M. A. , & Prinstein , M. J. ( in press ). Evidence base updates: The evolution of the evaluation of psychological treatments for children and adolescents . Journal of Clinical Child and Adolescent Psychology . [Google Scholar]) using keyword searches and a review of tables of contents. We extend the conceptualization of treatment research by differentiating training interventions from behavior management and by reviewing the growing literature on training interventions. Consistent with the results of the previous review we conclude that behavioral parent training, behavioral classroom management, and behavioral peer interventions are well-established treatments. In addition, organization training met the criteria for a well-established treatment. Combined training programs met criteria for Level 2 (Probably Efficacious), neurofeedback training met criteria for Level 3 (Possibly Efficacious), and cognitive training met criteria for Level 4 (Experimental Treatments). The distinction between behavior management and training interventions provides a method for considering meaningful differences in the methods and possible mechanisms of action for treatments for these youth. Characteristics of treatments, participants, and measures, as well as the variability in methods for classifying levels of evidence for treatments, are reviewed in relation to their potential effect on outcomes and conclusions about treatments. Implications of these findings for future science and practice are discussed.

Journal of Clinical Child & Adolescent Psychology · systematic review · 731 citationsread the source →

Evaluation of a structured skills training group for adolescents with attention deficit/hyperactivity disorder (ADHD) - study protocol of a randomised controlled trial.

Background: Attention deficit/hyperactivity disorder (ADHD) has a negative impact on several domains of life. However, there is a shortage of evidence-based non-pharmacological treatments for adolescents with ADHD. A structured skills training group (SSTG) based on dialectical behaviour therapy (DBT) has been used in adult patients with ADHD with some promising results, although the treatment has not yet been adapted or evaluated for adolescents with ADHD. This study protocol describes how this treatment was adapted for an adolescent population and how the efficacy of the SSTG will be evaluated using a randomised controlled trial (RCT) design. Methods: A sample of 184 adolescents (15-18 years of age) with a diagnosis of ADHD has been recruited from seven child and adolescent psychiatric outpatient units and randomised to either the SSTG or an active control group based on psychoeducation. Measures are conducted weekly during the treatment, as well as 2 weeks before treatment and 2 weeks and 6 months after treatment. The primary outcome measures are ADHD symptoms, functional impairment, quality of life and mindfulness. Secondary outcome measures are symptoms of comorbid psychopathology, perceived stress and sleep problems. This article describes the design, methods and analysis plan for evaluating the efficacy of the SSTG. Discussion: The study will be the first RCT to examine the acceptability and efficacy of a SSTG based on DBT adapted for adolescents with ADHD. We believe that the study will extend the current knowledge base about psychological treatment for adolescents with ADHD. Trial registration: ISRCTN registry ( ISRCTN17366720 ). Retrospectively registered May 112,016.

BMC psychiatry · clinical trial · 6 citationsread the source →

The effect of a community-based self-help multimodal behavioral intervention in Korean American seniors with high blood pressure.

Background: Great strides have been made in improving heart health in the United States during the last 2 decades, yet these strides have not encompassed many ethnic minority populations. There are significant health disparity gaps stemming from both a paucity of valid research and a lack of culturally sensitive interventions. In particular, many Korean Americans with chronic illnesses encounter difficulty navigating the healthcare system because of limited health literacy. Methods: The effect of a multimodal Self-Help Intervention Program on the Control of High Blood Pressure (HBP) was tested in a community-based clinical trial for Korean American seniors. Of 440 seniors enrolled, 369 completed the study (184 in the intervention group and 185 in the control group; mean age = 70.9±5.3 years). The intervention group received 6 weekly educational sessions on HBP management skill building, including health literacy training, followed by telephone counseling and home blood pressure (BP) monitoring for 12 months. Results: Findings support that the Self-Help Intervention Program on the Control of HBP was effective in controlling BP in this ethnic/linguistic minority population. The BP control rates for the intervention and control groups were 49.5% vs. 43.2% at baseline, 58.5% vs. 42.4% at 6 months, 67.9% vs. 52.5% at 12 months, and 54.3% vs. 53.0% at 18 months. Significant changes were observed over time in some psychobehavioral outcomes, including self-efficacy for BP control, medication adherence behavior, HBP knowledge, and depression. Conclusions: The study findings suggest that the multimodal Self-Help Intervention Program on the Control of HBP is effective at promoting optimal HBP control for this ethnic/linguistic minority population. Clinical trials registry: NCT00406614.

American journal of hypertension · randomised controlled trial · 51 citationsread the source →

Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial.

Context: Poor medication adherence diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications, placing them at increased risk for nonadherence. Objective: To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C). Design, setting, and patients: A multiphase, prospective study with an observational phase and a randomized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications. The study was conducted from June 2004 to August 2006. Intervention: After a 2-month run-in phase (measurement of baseline adherence, BP, and LDL-C), patients entered a 6-month intervention phase (standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific packs). Following the intervention phase, patients were randomized to continued pharmacy care vs usual care for an additional 6 months. Main outcome measures: Primary end point of the observation phase was change in the proportion of pills taken vs baseline; secondary end points were the associated changes in BP and LDL-C. Primary end point of the randomization phase was the between-group comparison of medication persistence. Results: A total of 200 elderly patients (77.1% men; mean [SD] age, 78 [8.3] years), taking a mean (SD) of 9 (3) chronic medications were enrolled. Coronary risk factors included drug-treated hypertension in 184 patients (91.5%) and drug-treated hyperlipidemia in 162 (80.6%). Mean (SD) baseline medication adherence was 61.2% (13.5%). After 6 months of intervention, medication adherence increased to 96.9% (5.2%; P<.001) and was associated with significant improvements in systolic BP (133.2 [14.9] to 129.9 [16.0] mm Hg; P = .02) and LDL-C (91.7 [26.1] to 86.8 [23.4] mg/dL; P = .001). Six months after randomization, the persistence of medication adherence decreased to 69.1% (16.4%) among those patients assigned to usual care, whereas it was sustained at 95.5% (7.7%) in pharmacy care (P<.001). This was associated with significant reductions in systolic BP in the pharmacy care group (-6.9 mm Hg; 95% CI, -10.7 to -3.1 mm Hg) vs the usual care group (-1.0 mm Hg; 95% CI, -5.9 to 3.9 mm Hg; P = .04), but no significant between-group differences in LDL-C levels or reductions. Conclusions: A pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence. Trial registration: clinicaltrials.gov Identifier: NCT00393419

JAMA · randomised controlled trial · 517 citationsread the source →

Intranasal oxytocin and salivary cortisol concentrations during social rejection in university students.

Oxytocin facilitates pro-social behaviour and is proposed as a regulatory factor controlling stress reactivity. Previous research on oxytocin and stress has focused on achievement-related stressors among male participants. The aims of the study were to (1) examine the influence of oxytocin on the affective and cortisol response to the Yale Interpersonal Stressor (YIPS), a live social rejection paradigm, and (2) to replicate the finding that women exhibit a greater cortisol response to interpersonal stress than men (Stroud et al. 2002). Sex differences in stress responses: Social rejection versus achievement stress. Biol Psychiat 53:318-327. Ninety-six undergraduate students underwent the YIPS, where participants were excluded from two separate conversations by two same-sex confederates. Salivary cortisol concentrations and mood were repeatedly measured throughout the study. Participants were administered, in a double-blind design, a single dose of intranasal oxytocin (24 IU) or placebo prior to beginning the YIPS. The YIPS elicited a significant negative mood response that was more pronounced in females than in males. However, no significant cortisol response to the stressor and no sex difference in cortisol reactivity were observed. A significant effect of drug condition on cortisol levels was observed. Participants who were administered oxytocin exhibited a decrease in cortisol levels, relative to placebo, during the YIPS, F (4, 184)=4.50, p<0.05. The study failed to replicate the sex difference in the cortisol response to interpersonal stress reported by Stroud et al. (2002). Intranasal oxytocin, however, appeared to reduce cortisol concentrations during an interpersonal challenge.

Stress (Amsterdam, Netherlands) · randomised controlled trial · 72 citationsread the source →

[French validation of the anger reactions and goals scale (RBC)].

Background: The study presents the French validation of a German scale (AERZ) [Diagnostica 49 (2003) 97-109, revised Eur J Pers (2009)] measuring anger regulation. The French validation (RBC scale) comprises two subscales measuring seven anger reactions and seven anger goals. Disentangling dimensions related to anger reactions and anger goals, respectively, is the main advantage of this scale. In addition to seven cognitive-behavioral anger reactions (i.e., venting, rumination, submission, feedback, distraction, humor and downplaying the incident's negative impact), the RBC scale also addresses the cognitive representations underlying anger reactions by exploring anger goals (i.e., enforcing personal standards, enforcing social standards, downregulating affect, avoiding conflicts, protecting one's reputation, weighing costs and gaining revenge). Method: The original scale was translated following the scientific guidelines and recommendations for cultural adaptation of instruments. The adapted French version was tested with a sample of students (n=184, 70.7% were females) from the University of Luxembourg (M=21.31, S.D.=1.93). Students filled in a questionnaire composed of the RBC scale, the SF-36 quality of life scale and the STAXI-II anger instrument. The RBC scale comprises 56 items; reactions are assessed on a 4 point Likert scale from "almost never" (1) to "always" (4), whereas goals are assessed on a 4 point Likert scale from "not at all" (1) to "completely" (4). Results: Factor analysis revealed a seven-factor solution for the anger reactions subscale (that explained 63.13% of the common variance) and a six-factor solution for the anger goals subscale (that explained 57.45% of the common variance). The original factorial structure was examined in confirmatory factor analysis. For the anger reactions subscale, a good model fit was found, with chi(2)(329)=546.38, p<0.1, CFI=0.87, RMSEA=0.06. For the anger goals subscale, a satisfactory model fit was observed, with chi(2)(335)=658.52, p<0.1, CFI=0.78, RMSEA=0.07 revealing a six-factorial structure that differed from the original version in the combination of two dimensions ("downregulating affect" and "protecting one's reputation"). The RBC scale's internal consistencies were found satisfactory with Cronbach's alphas ranging from 0.60 to 0.83 for the various dimensions. Part-whole correlations ranged from r(it)=0.27 to 0.80. Gender differences showed that female participants used significantly more rumination strategies and emotional regulation, whereas male students demonstrated greater humor in anger situations. Significant correlations between RBC and STAXI-II confirmed the construct validity of the RBC scale. Criteria validity was analyzed using the predictive value of the RBC dimensions on the quality of life subscales of the SF-36. Conclusion: The present results support the validity, the reliability and the sensitivity of the 56 items scale on anger regulation and its use in psychological research. Although our findings need to be replicated and the test-retest validity is subject to future verification, the present validation of the RBC scale offers a multidimensional inventory for measuring anger reactions and anger goals. This inventory may be used, for example, as a diagnostic tool or for testing the effectiveness of anger management interventions.

L'Encephale · cohort or longitudinal · 4 citationsread the source →

Age at onset and clinical correlates in body dysmorphic disorder.

Objective: Age at onset is an important clinical feature of all disorders. However, no prior studies have focused on this important construct in body dysmorphic disorder (BDD). In addition, across a number of psychiatric disorders, early age at disorder onset is associated with greater illness severity and greater comorbidity with other disorders. However, clinical correlates of age at onset have not been previously studied in BDD. Methods: Age at onset and other variables of interest were assessed in two samples of adults with DSM-IV BDD; sample 1 consisted of 184 adult participants in a study of the course of BDD, and sample 2 consisted of 244 adults seeking consultation or treatment for BDD. Reliable and valid measures were used. Subjects with early-onset BDD (age 17 or younger) were compared to those with late-onset BDD. Results: BDD had a mean age at onset of 16.7 (SD=7.3) in sample 1 and 16.7 (SD=7.2) in sample 2. 66.3% of subjects in sample 1 and 67.2% in sample 2 had BDD onset before age 18. A higher proportion of females had early-onset BDD in sample 1 but not in sample 2. On one of three measures in sample 1, those with early-onset BDD currently had more severe BDD symptoms. Individuals with early-onset BDD were more likely to have attempted suicide in both samples and to have attempted suicide due to BDD in sample 2. Early age at BDD onset was associated with a history of physical violence due to BDD and psychiatric hospitalization in sample 2. Those with early-onset BDD were more likely to report a gradual onset of BDD than those with late-onset in both samples. Participants with early-onset BDD had a greater number of lifetime comorbid disorders on both Axis I and Axis II in sample 1 but not in sample 2. More specifically, those with early-onset BDD were more likely to have a lifetime eating disorder (anorexia nervosa or bulimia nervosa) in both samples, a lifetime substance use disorder (both alcohol and non-alcohol) and borderline personality disorder in sample 1, and a lifetime anxiety disorder and social phobia in sample 2. Conclusions: BDD usually began during childhood or adolescence. Early onset was associated with gradual onset, a lifetime history of attempted suicide, and greater comorbidity in both samples. Other clinical features reflecting greater morbidity were also more common in the early-onset group, although these findings were not consistent across the two samples.

Comprehensive psychiatry · 105 citationsread the source →

Community health worker promotions increase uptake of long-acting reversible contraception in Rwanda.

Background: We coordinated community health worker (CHW) promotions with training and support of government clinic nurses to increase uptake of long-acting reversible contraception (LARC), specifically the copper intrauterine device (IUD) and the hormonal implant, in Kigali, Rwanda. Methods: From August 2015 to September 2016, CHW provided fertility goal-based family planning counseling focused on LARC methods, engaged couples in family planning counseling, and provided written referrals to clients expressing interest in LARC methods. Simultaneously, we provided didactic and practical training to clinic nurses on LARC insertion and removal. We evaluated: 1) aggregate pre- versus post-implementation LARC uptake as a function of CHW promotions, and 2) demographic factors associated with LARC uptake among women responding to CHW referrals. Results: 7712 referrals were delivered by 184 CHW affiliated with eight government clinics resulting in 6072 family planning clinic visits (79% referral uptake). 95% of clinic visits resulted in LARC uptake (16% copper IUD, 79% hormonal implant). The monthly average for IUD insertions doubled from 29 prior to service implementation to 61 after (p < 0.0001), and the monthly average for implant insertions increased from 109 to 309 (p < 0.0001). In adjusted analyses, LARC uptake was associated (p < 0.05) with the CHW referral being issued to the couple (versus the woman alone, adjusted odds ratio, aOR = 2.6), having more children (aOR = 1.3), desiring more children (aOR = 0.8), and having a religious affiliation (aOR = 2.9 Protestant, aOR = 3.1 Catholic, aOR = 2.5 Muslim each versus none/other). Implant versus non-LARC uptake was associated with having little or no education; meanwhile, having higher education was associated with IUD versus implant uptake. Conclusions: Fertility goal-based and couple-focused family planning counseling delivered by CHW, coupled with LARC training and support of nursing staff, substantially increased uptake of LARC methods.

Reproductive health · 23 citationsread the source →

Child Sleep Problems Affect Mothers and Fathers Differently: How Infant and Young Child Sleep Affects Paternal and Maternal Sleep Quality, Emotion Regulation, and Sleep-Related Cognitions.

Purpose: Problems in infant and young child sleep can represent a serious challenge to parental behavior of mother and father. However, most research about the effect of infant and young child sleep on parenting has focused on mothers. Therefore, the present study aimed to explore the perception and consequences of infant and young child sleep problems of both parents. Participants and methods: Participants were recruited via random sampling at, eg, kindergartens in North Rhine Westphalia. The sample includes data of heterosexual German-speaking couples with children without any medical or psychopathological problems. For this study, parents were asked to complete the test battery with regard to their youngest child. As sampling was via the kindergarten, the range of child age was 4-68 months. A survey assessed data of parents (N=196, 46% female). The test battery contained the following questionnaires: Children Sleep Habits Questionnaire (CSHQ), Pittsburgh Sleep Quality Index (PSQI), Self-Report Measure for the Assessment of Emotion Regulation Skills (SEK-27), and a German version of the Infant Sleep Vignettes Interpretation Scale (ISVIS). For the outcome variables of parental sleep as well as for parental emotional competence, the statistical tests of ANOVA were used, and for parental sleep-related cognitions with the grouping variables of infant and young child sleep as well as parental gender, a MANOVA was used. According to the analysis of group differences, the age of the child was also included additional to the grouping variable of parental gender and children's sleep. Results: Mothers and fathers in this sample were equally aware of their children's sleep problems and reported similar sleep quality and emotion regulation themselves (all p > 0.05). Mothers as well as fathers of children with sleep problems had lower parental sleep quality (F(1, 183) = 110.01, p < 0.001) and emotion regulation (F(1, 184) = 143.16, p < 0.001) compared to parents of children without sleep problems. In children under 26 months of age, the child's age seemed to have less negative impact on the father's sleep quality (F(1, 183) = 5.01, p < 0.001) and emotion regulation (F(1, 184) = 0.72, p < 0.05) than on the outcomes of the mother. With regard to sleep-related cognition, there were statistically significant effects of parental gender (F(2, 185) = 44.39, p < 0.001) and interaction effects of parental gender × child sleep problems observed (F(2, 185) = 31.91, p < 0.001). Conclusion: The conclusion from this survey refers to the role of the father. According to the results, an association between paternal emotional competence, sleep quality as well as their sleep-related cognitions and infants and toddlers sleep behavior could be assumed in addition to and independent of the results of mothers. We would highlight the urgent need of inclusion of fathers in infant and developmental sleep research. In the context of sleep intervention, both parents should be provided with ongoing support to improve their sleep quality and competence in emotion regulation.

Nature and science of sleep · 25 citationsread the source →

Cognitive and psychiatric symptom trajectories 2-3 years after hospital admission for COVID-19: a longitudinal, prospective cohort study in the UK.

Background: COVID-19 is known to be associated with increased risks of cognitive and psychiatric outcomes after the acute phase of disease. We aimed to assess whether these symptoms can emerge or persist more than 1 year after hospitalisation for COVID-19, to identify which early aspects of COVID-19 illness predict longer-term symptoms, and to establish how these symptoms relate to occupational functioning. Methods: The Post-hospitalisation COVID-19 study (PHOSP-COVID) is a prospective, longitudinal cohort study of adults (aged ≥18 years) who were hospitalised with a clinical diagnosis of COVID-19 at participating National Health Service hospitals across the UK. In the C-Fog study, a subset of PHOSP-COVID participants who consented to be recontacted for other research were invited to complete a computerised cognitive assessment and clinical scales between 2 years and 3 years after hospital admission. Participants completed eight cognitive tasks, covering eight cognitive domains, from the Cognitron battery, in addition to the 9-item Patient Health Questionnaire for depression, the Generalised Anxiety Disorder 7-item scale, the Functional Assessment of Chronic Illness Therapy Fatigue Scale, and the 20-item Cognitive Change Index (CCI-20) questionnaire to assess subjective cognitive decline. We evaluated how the absolute risks of symptoms evolved between follow-ups at 6 months, 12 months, and 2-3 years, and whether symptoms at 2-3 years were predicted by earlier aspects of COVID-19 illness. Participants completed an occupation change questionnaire to establish whether their occupation or working status had changed and, if so, why. We assessed which symptoms at 2-3 years were associated with occupation change. People with lived experience were involved in the study. Findings: 2469 PHOSP-COVID participants were invited to participate in the C-Fog study, and 475 participants (191 [40·2%] females and 284 [59·8%] males; mean age 58·26 [SD 11·13] years) who were discharged from one of 83 hospitals provided data at the 2-3-year follow-up. Participants had worse cognitive scores than would be expected on the basis of their sociodemographic characteristics across all cognitive domains tested (average score 0·71 SD below the mean [IQR 0·16-1·04]; p<0·0001). Most participants reported at least mild depression (263 [74·5%] of 353), anxiety (189 [53·5%] of 353), fatigue (220 [62·3%] of 353), or subjective cognitive decline (184 [52·1%] of 353), and more than a fifth reported severe depression (79 [22·4%] of 353), fatigue (87 [24·6%] of 353), or subjective cognitive decline (88 [24·9%] of 353). Depression, anxiety, and fatigue were worse at 2-3 years than at 6 months or 12 months, with evidence of both worsening of existing symptoms and emergence of new symptoms. Symptoms at 2-3 years were not predicted by the severity of acute COVID-19 illness, but were strongly predicted by the degree of recovery at 6 months (explaining 35·0-48·8% of the variance in anxiety, depression, fatigue, and subjective cognitive decline); by a biocognitive profile linking acutely raised D-dimer relative to C-reactive protein with subjective cognitive deficits at 6 months (explaining 7·0-17·2% of the variance in anxiety, depression, fatigue, and subjective cognitive decline); and by anxiety, depression, fatigue, and subjective cognitive deficit at 6 months. Objective cognitive deficits at 2-3 years were not predicted by any of the factors tested, except for cognitive deficits at 6 months, explaining 10·6% of their variance. 95 of 353 participants (26·9% [95% CI 22·6-31·8]) reported occupational change, with poor health being the most common reason for this change. Occupation change was strongly and specifically associated with objective cognitive deficits (odds ratio [OR] 1·51 [95% CI 1·04-2·22] for every SD decrease in overall cognitive score) and subjective cognitive decline (OR 1·54 [1·21-1·98] for every point increase in CCI-20). Interpretation: Psychiatric and cognitive symptoms appear to increase over the first 2-3 years post-hospitalisation due to both worsening of symptoms already present at 6 months and emergence of new symptoms. New symptoms occur mostly in people with other symptoms already present at 6 months. Early identification and management of symptoms might therefore be an effective strategy to prevent later onset of a complex syndrome. Occupation change is common and associated mainly with objective and subjective cognitive deficits. Interventions to promote cognitive recovery or to prevent cognitive decline are therefore needed to limit the functional and economic impacts of COVID-19. Funding: National Institute for Health and Care Research Oxford Health Biomedical Research Centre, Wolfson Foundation, MQ Mental Health Research, MRC-UK Research and Innovation, and National Institute for Health and Care Research.

The lancet. Psychiatry · 46 citationsread the source →

Effectiveness of the IDEFICS intervention on objectively measured physical activity and sedentary time in European children.

Background: This paper reports on the effectiveness of the prevention of dietary- and lifestyle-induced health effects in children and infants (IDEFICS) intervention on objectively measured physical activity (PA) and sedentary time (ST) in 2- to 9.9-year-old European boys and girls. Methods: The intervention was evaluated after 2 years through a non-randomized cluster-controlled trial in eight European countries (one control and one intervention community per country). All children in the intervention group received a culturally adapted childhood obesity prevention programme through the community, schools/kindergartens and family. A random sub-sample of children participating in the IDEFICS study wore an accelerometer at baseline and follow-up for at least 3 days (n = 9,184). Of this sample, 81% provided valid accelerometer data at baseline (n = 7,413; 51% boys; 6.21 ± 1.76 years; boys: 617 ± 170 cpm day(-1) ; girls 556 ± 156 cpm day(-1) ) and 3,010 children provided valid accelerometer data at baseline and during the follow-up survey 2 years later. Results: In boys and girls, no significant differences in PA and ST were found between intervention and control groups over 2 years. Strong temporal effects were found in the total sample of boys and girls: the percentage of time spent in light PA per day decreased by 4 percentage points in both boys and girls between baseline and follow-up (both: p < 0.001), while time spent in ST per day increased by 4 percentage points in both sexes over time (both: p < 0.001). Percentage of time spent in moderate-to-vigorous PA per day remained stable over time in boys and girls. Conclusion: Despite the socio-ecological approach and implementation of a culturally adapted intervention in each country, no effects of the IDEFICS intervention were found on children's objectively measured PA and ST. Behavioural interventions for children may need to enhance specificity and intensity at the family level using other behaviour change techniques and more direct strategies to reach parents.

Obesity reviews : an official journal of the International Association for the Study of Obesity · 22 citationsread the source →

Association Between the Use of Social Media and Photograph Editing Applications, Self-esteem, and Cosmetic Surgery Acceptance.

Importance: Social media platforms and photograph (photo) editing applications are increasingly popular sources of inspiration for individuals interested in cosmetic surgery. However, the specific associations between social media and photo editing application use and perceptions of cosmetic surgery remain unknown. Objective: To assess whether self-esteem and the use of social media and photo editing applications are associated with cosmetic surgery attitudes. Design, setting, and participants: A population-based survey study was conducted from July 1 to September 19, 2018. The web-based survey was administered through online platforms to 252 participants. Main outcomes and measures: Each participant's self-esteem was measured using the Rosenberg Self-esteem Scale (scores range from 0-30; higher scores indicate higher self-esteem) and the Contingencies of Self-worth Scale (scores range from 1-7; higher scores indicate higher self-worth). Cosmetic surgery attitude was measured using the Acceptance of Cosmetic Surgery Scale (scores range from 1-7; higher scores indicate higher acceptance of cosmetic surgery). Unpaired, 2-tailed t tests were used to assess the significance of self-esteem and cosmetic surgery attitude score differences among users of various social media and photo editing applications. Structural equation modeling was used to assess the association between social media investment and cosmetic surgery attitudes. Results: Of the 252 participants, 184 (73.0%) were women, 134 (53.2%) reported themselves to be white, and the mean age was 24.7 (range, 18-55) years. Scores on the Rosenberg Self-esteem Scale from users and nonusers across applications were compared, with lower self-esteem scores noted in participants who reported using YouTube (difference in scores, -1.56; 95% CI, -3.01 to -0.10), WhatsApp (difference in scores, -1.47; 95% CI, -2.78 to -0.17), VSCO (difference in scores, -3.20; 95% CI, -4.98 to -1.42), and Photoshop (difference in scores, -2.92; 95% CI, -5.65 to -0.19). Comparison of self-esteem scores for participants who reported using other social media and photo editing applications yielded no significant differences. Social media investment had a positive association with consideration of cosmetic surgery (R, 0.35; 95% CI, 0.04-0.66). A higher overall score on the Acceptance of Cosmetic Surgery Scale was noted in users of Tinder (difference in means, 0.79; 95% CI, 0.34-1.23), Snapchat (difference in means, 0.39; 95% CI, 0.07 to 0.71), and/or Snapchat photo filters (difference in means, 0.44; 95% CI, 0.16-0.72). Increased consideration of cosmetic surgery but not overall acceptance of surgery was noted in users of VSCO (difference in means, 0.84; 95% CI, 0.32-1.35) and Instagram photo filters (difference in means, 0.38; 95% CI, 0.01-0.76) compared with nonusers. Conclusions and relevance: This study's findings suggest that the use of certain social media and photo editing applications may be associated with increased acceptance of cosmetic surgery. These findings can help guide future patient-physician discussions regarding cosmetic surgery perceptions, which vary by social media or photo editing application use. Level of evidence: NA.

JAMA facial plastic surgery · 90 citationsread the source →

Clinical depression is a strong predictor of poor lumbar fusion outcomes among workers' compensation subjects.

Study design: Retrospective cohort study. Objective: Determine how psychosocial factors, particularly depression, impact lumbar fusion outcomes in a workers' compensation (WC) setting. Summary of background data: WC patients are less likely to return to work (RTW) after fusion. Few studies evaluate risk factors within this clinically distinct population. Methods: A total of 2799 Ohio WC subjects were identified who underwent lumbar fusion between 1993 and 2013 using Current Procedural Terminology (CPT) procedural and International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes. A total of 123 subjects were diagnosed with depression before fusion. Subjects with a smoking history, prior lumbar surgery, permanent disability, and failed back syndrome were excluded. The primary outcome was whether subjects returned to work within 2 years of fusion and sustained this RTW for more than 6 months of the following year. To determine the impact depression had on RTW status, we performed a multivariate logistic regression analysis. We also compared time absent from work and other secondary outcomes using χ2 and t tests. Results: Subjects with preoperative depression had significantly higher rates of legal representation, degenerative lumbar disease, and higher medical costs, and used opioid analgesics for considerably longer before and after fusion (P<0.001).Depression group (10.6% [13/123]) and controls (33.0% [884/2676]) met our RTW criteria (P<0.001). Preoperative depression was a negative predictor of RTW status (P<0.001; odds ratio [OR]: 0.38). Additional predictors included working during same week as fusion (OR: 2.15), age more than 50 years (OR: 0.58), chronic preoperative opioid analgesia (OR: 0.58), and legal representation (OR: 0.64). After surgery, depression subjects were absent from work 184 more days compared with controls (P<0.001). Conclusion: Overall, RTW rates after fusion were low, which was especially true for those with pre-existing depression. Depression was a strong negative predictor of postoperative RTW status. Psychological screening and treatment may be beneficial in these subjects. The poor outcomes in this study may highlight a more limited role for fusion among WC subjects with chronic low back pain where RTW is the treatment goal. Level of evidence: 3.

Spine · 76 citationsread the source →

Identifying factors associated with successful implementation and uptake of an evidence-based voluntary medical male circumcision program in Zambia: the Spear and Shield 2 Program.

Voluntary medical male circumcision has been shown to provide a 50%-70% reduction in the risk of HIV infection without contributing to behavioral disinhibition of safer sexual practices. This study examined the interim implementation and dissemination data of Spear and Shield 2, an HIV risk-reduction program in Zambia. The purpose of this interim review was to identify contextual challenges to implementation and implement midcourse corrections associated with sustainability of program delivery. Using a mixed-methods design, quantitative evaluations of organizational functioning, barriers to implementation, burnout, and organizational readiness, as well as qualitative data utilizing the Consolidated Framework for Implementation Research (CFIR), were examined to evaluate program implementation. Participants were 184 health care providers from 46 clinics in Zambia. Successful implementation was associated with better community and leader support, and employee readiness and motivation. Quantitative assessments were not related to implementation and provided a limited picture of implementation outcomes. Results suggest that the qualitative data underlying the CFIR constructs provided a nuanced, contextual assessment of implementation, and dissemination outcomes. The CFIR may be valuable in informing the implementation of evidence-based interventions in other parts of Zambia.

Translational behavioral medicine · 8 citationsread the source →

Food insecurity and maternal depression in rural, low-income families: a longitudinal investigation.

Objective: The purpose of the present study was to examine the relationship between household food insecurity and maternal depression in a rural sample to determine whether food insecurity predicted mothers' depression over time or vice versa. Design: The study employed a prospective design using three waves of data from 'Rural Families Speak', a multi-state study of low-income rural families in the USA. Food insecurity was measured using the Core Food Security Module and depression was measured using the Center for Epidemiologic Studies-Depression Scale. A structural equation model was fit to the data using the AMOS software package. Setting: Sixteen states in the USA (California, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Nebraska, New Hampshire, New York, Ohio, Oregon, South Dakota, West Virginia, Wyoming) between 2000 and 2002. Subjects: Subjects included 413 women with at least one child under the age of 13 years living in the home. Results: Findings based on the 184 subjects with complete data indicated that the causal relationship between household food insecurity and depression is bidirectional (P = 0.034 for causation from depression to food insecurity, P = 0.003 for causation from food insecurity to depression, chi(2)/df = 1.835, root-mean-square error of approximation = 0.068, comparative fit index = 0.989). Findings based on all 413 subjects after imputation of missing values also indicated bidirectionality. Conclusions: The recursive relationship between food insecurity and depression has implications for US nutrition, mental health and poverty policies. The study highlights the need to integrate programmes addressing food insecurity and poor mental health for the population of rural, low-income women.

Public health nutrition · 135 citationsread the source →

Analysis of shortened versions of the tampa scale for kinesiophobia and pain catastrophizing scale for patients after anterior cruciate ligament reconstruction.

Objective: Recent work suggests that psychological influence on pain intensity and knee function should be considered for patients after anterior cruciate ligament reconstruction (ACLR). The Tampa Scale for Kinesiophobia (TSK) and Pain Catastrophizing Scale (PCS) have been used to determine psychological influence in these patients. However, TSK and PCS factor structures have not been described for patients with ACLR. This study investigated 2 groups of patients post-ACLR to determine if the use of shortened questionnaires is warranted. Methods: Cross-sectional study in which patients completed measures during early (n=105, median days from surgery=56.0) and late (n=184, median days from surgery=195.0) postoperative phases of ACLR rehabilitation. Results: Shortened questionnaires for fear of pain, fear of injury, and somatic focus were generated for the TSK-11. A shortened questionnaire for magnification/helplessness and rumination was generated for the PCS in the late group only. There were minimal differences in the shortened questionnaires for clinical subgroups based on sex, ACLR graft type, method of injury, or nature of injury. Correlation and regression analyses suggested a shortened version of the TSK-11 for fear of injury was appropriate for use in the early postoperative phase, whereas the original TSK-11 scale may be appropriate for use in the late postoperative phase. There were no shortened versions of the PCS for consideration in the early postoperative phase, but a shortened version for magnification/helplessness was appropriate for use in the late postoperative phase. Discussion: Shortened versions of the TSK-11 and PCS may be appropriate for ACLR populations, depending on the postoperative phase. These data may guide future research of psychological factors in ACLR populations so that levels predictive of risk for developing chronic pain and/or inability to return to pre-injury activity levels can be determined.

The Clinical journal of pain · 102 citationsread the source →

Association of DRD4 and COMT polymorphisms with anger and forgiveness traits in healthy volunteers.

Although the biological basis of trait anger, anger expression, and forgiveness are not well understood, there has been growing evidence that anger-related dispositions are heritable and associated with genetic polymorphisms. The purpose of the present study was to investigate the possible relationship between anger and forgiveness traits and the dopamine receptor D4 (DRD4) and catechol-O-methyltransferase (COMT) Val158 Met polymorphisms in healthy Korean subjects. Three hundred and thirty-five healthy college students were recruited, and the 308 participants with a complete data set (184 males, 124 females) were included in the data analysis. DNA of the subjects was isolated from whole blood cells, and DRD4 variable number of tandem repeats and COMT Val158 Met polymorphisms were genotyped using polymerase chain reaction. Participants performed the State-Trait Anger Expression Inventory and Trait Forgivingness Scale measuring anger and forgiveness traits. The DRD4 2-repeat (2R) allele group had significantly lower anger in tendency and higher forgiveness traits than the 4R allele group in males. Our results provide evidence that the 2R allele of DRD4 in a Korean sample might have a different function from the 4R allele and a gender-specific role on anger-related traits. The COMT Val158 Met polymorphism had no significant relationship with anger and forgiveness traits. These findings suggest a possible relationship between anger expression styles and forgiveness traits and dopaminergic dysfunction.

Neuroscience letters · 19 citationsread the source →