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Mediators of weight loss and weight loss maintenance in middle-aged women.

Long-term behavioral self-regulation is the hallmark of successful weight control. We tested mediators of weight loss and weight loss maintenance in middle-aged women who participated in a randomized controlled 12-month weight management intervention. Overweight and obese women (N = 225, BMI = 31.3 +/- 4.1 kg/m(2)) were randomly assigned to a control or a 1-year group intervention designed to promote autonomous self-regulation of body weight. Key exercise, eating behavior, and body image variables were assessed before and after the program, and tested as mediators of weight loss (12 months, 86% retention) and weight loss maintenance (24 months, 81% retention). Multiple mediation was employed and an intention-to-treat analysis conducted. Treatment effects were observed for all putative mediators (Effect size: 0.32-0.79, P < 0.01 vs. controls). Weight change was -7.3 +/- 5.9% (12-month) and -5.5 +/- 5.0% (24-month) in the intervention group and -1.7 +/- 5.0% and -2.2 +/- 7.5% in controls. Change in most psychosocial variables was associated with 12-month weight change, but only flexible cognitive restraint (P < 0.01), disinhibition (P < 0.05), exercise self-efficacy (P < 0.001), exercise intrinsic motivation (P < 0.01), and body dissatisfaction (P < 0.05) predicted 24-month weight change. Lower emotional eating, increased flexible cognitive restraint, and fewer exercise barriers mediated 12-month weight loss (R(2) = 0.31, P < 0.001; effect ratio: 0.37), but only flexible restraint and exercise self-efficacy mediated 24-month weight loss (R(2) = 0.17, P < 0.001; effect ratio: 0.89). This is the first study to evaluate self-regulation mediators of weight loss and 2-year weight loss maintenance, in a large sample of overweight women. Results show that lowering emotional eating and adopting a flexible dietary restraint pattern are critical for sustained weight loss. For long-term success, interventions must also be effective in promoting exercise intrinsic motivation and self-efficacy.

Obesity (Silver Spring, Md.) · randomised controlled trial · 249 citationsread the source →

Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study.

Background: The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States. Objectives: The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair. Methods: Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled. Results: In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%. Conclusions: The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274).

Journal of the American College of Cardiology · randomised controlled trial · 321 citationsread the source →

The HARMONY Trial: Combined Ranolazine and Dronedarone in the Management of Paroxysmal Atrial Fibrillation: Mechanistic and Therapeutic Synergism.

Background: Atrial fibrillation (AF) requires arrhythmogenic changes in atrial ion channels/receptors and usually altered atrial structure. AF is commonly treated with antiarrhythmic drugs; the most effective block many ion channels/receptors. Modest efficacy, intolerance, and safety concerns limit current antiarrhythmic drugs. We hypothesized that combining agents with multiple anti-AF mechanisms at reduced individual drug doses might produce synergistic efficacy plus better tolerance/safety. Methods and results: HARMONY tested midrange ranolazine (750 mg BID) combined with 2 reduced dronedarone doses (150 mg BID and 225 mg BID; chosen to reduce dronedarone's negative inotropic effect-see text below) over 12 weeks in 134 patients with paroxysmal AF and implanted pacemakers where AF burden (AFB) could be continuously assessed. Patients were randomized double-blind to placebo, ranolazine alone (750 mg BID), dronedarone alone (225 mg BID), or one of the combinations. Neither placebo nor either drugs alone significantly reduced AFB. Conversely, ranolazine 750 mg BID/dronedarone 225 mg BID reduced AFB by 59% versus placebo (P=0.008), whereas ranolazine 750 mg BID/dronedarone 150 mg BID reduced AFB by 43% (P=0.072). Both combinations were well tolerated. Conclusions: HARMONY showed synergistic AFB reduction by moderate dose ranolazine plus reduced dose dronedarone, with good tolerance/safety, in the population enrolled. Clinical trial registration: ClinicalTrials.gov; Unique identifier: NCT01522651.

Circulation. Arrhythmia and electrophysiology · randomised controlled trial · 115 citationsread the source →

Gender differences among children with DSM-IV ADHD in Australia.

Objective: To examine gender differences among children meeting symptom criteria for DSM-IV attention-deficit/hyperactivity disorder (ADHD) identified in a nationally representative sample of Australian children. Method: From 2,404 children aged 6 to 13 years, 225 boys and 99 girls with ADHD symptoms were identified using the parent version of the Diagnostic Interview Schedule for Children and compared on parent reports of children's behavioral problems and impairment. Results: When ADHD types were collapsed into a single group, boys and girls did not differ on core symptoms, comorbidity, and impairment with the exception that girls rated higher on somatic complaints and boys had poorer school functioning. However, gender patterns were found to vary across ADHD type on impairment measures of social problems, schoolwork difficulties, and self-esteem, with boys being generally rated as more impaired in the combined and hyperactive-impulsive groups but equally or less impaired in the inattentive group. Conclusions: The findings suggest the possibility of gender-specific risks associated with high levels of inattentive and hyperactive-impulsive symptoms indicating that ADHD subtype membership should be considered when conducting ADHD gender comparisons.

Journal of the American Academy of Child and Adolescent Psychiatry · cohort or longitudinal · 79 citationsread the source →

Behavioural and cognitive-behavioural interventions for outwardly directed aggressive behaviour in people with intellectual disabilities.

Background: Outwardly directed aggressive behaviour in people with intellectual disabilities is a significant issue that may lead to poor quality of life, social exclusion and inpatient psychiatric admissions. Cognitive and behavioural approaches have been developed to manage aggressive behaviour but the effectiveness of these interventions on reducing aggressive behaviour and other outcomes are unclear. This is the third update of this review and adds nine new studies, resulting in a total of 15 studies in this review. Objectives: To evaluate the efficacy of behavioural and cognitive-behavioural interventions on outwardly directed aggressive behaviour compared to usual care, wait-list controls or no treatment in people with intellectual disability. We also evaluated enhanced interventions compared to non-enhanced interventions. Search methods: We used standard, extensive Cochrane search methods. The latest search date was March 2022. We revised the search terms to include positive behaviour support (PBS). Selection criteria: We included randomised and quasi-randomised trials of children and adults with intellectual disability of any duration, setting and any eligible comparator. Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were change in 1. aggressive behaviour, 2. ability to control anger, and 3. adaptive functioning, and 4. Adverse effects: Our secondary outcomes were change in 5. mental state, 6. medication, 7. care needs and 8. quality of life, and 9. frequency of service utilisation and 10. user satisfaction data. We used GRADE to assess certainty of evidence for each outcome. We expressed treatment effects as mean differences (MD) or odds ratios (OR), with 95% confidence intervals (CI). Where possible, we pooled data using a fixed-effect model. Main results: This updated version comprises nine new studies giving 15 included studies and 921 participants. The update also adds new interventions including parent training (two studies), mindfulness-based positive behaviour support (MBPBS) (two studies), reciprocal imitation training (RIT; one study) and dialectical behavioural therapy (DBT; one study). It also adds two new studies on PBS. Most studies were based in the community (14 studies), and one was in an inpatient forensic service. Eleven studies involved adults only. The remaining studies involved children (one study), children and adolescents (one study), adolescents (one study), and adolescents and adults (one study). One study included boys with fragile X syndrome. Six studies were conducted in the UK, seven in the USA, one in Canada and one in Germany. Only five studies described sources of funding. Four studies compared anger management based on cognitive behaviour therapy to a wait-list or no treatment control group (n = 263); two studies compared PBS with treatment as usual (TAU) (n = 308); two studies compared carer training on mindfulness and PBS with PBS only (n = 128); two studies involving parent training on behavioural approaches compared to wait-list control or TAU (n = 99); one study of mindfulness to a wait-list control (n = 34); one study of adapted dialectal behavioural therapy compared to wait-list control (n = 21); one study of RIT compared to an active control (n = 20) and one study of modified relaxation compared to an active control group (n = 12). There was moderate-certainty evidence that anger management may improve severity of aggressive behaviour post-treatment (MD -3.50, 95% CI -6.21 to -0.79; P = 0.01; 1 study, 158 participants); very low-certainty evidence that it might improve self-reported ability to control anger (MD -8.38, 95% CI -14.05 to -2.71; P = 0.004, I2 = 2%; 3 studies, 212 participants), adaptive functioning (MD -21.73, 95% CI -36.44 to -7.02; P = 0.004; 1 study, 28 participants) and psychiatric symptoms (MD -0.48, 95% CI -0.79 to -0.17; P = 0.002; 1 study, 28 participants) post-treatment; and very low-certainty evidence that it does not improve quality of life post-treatment (MD -5.60, 95% CI -18.11 to 6.91; P = 0.38; 1 study, 129 participants) or reduce service utilisation and costs at 10 months (MD 102.99 British pounds, 95% CI -117.16 to 323.14; P = 0.36; 1 study, 133 participants). There was moderate-certainty evidence that PBS may reduce aggressive behaviour post-treatment (MD -7.78, 95% CI -15.23 to -0.32; P = 0.04, I2 = 0%; 2 studies, 275 participants) and low-certainty evidence that it probably does not reduce aggressive behaviour at 12 months (MD -5.20, 95% CI -13.27 to 2.87; P = 0.21; 1 study, 225 participants). There was low-certainty evidence that PBS does not improve mental state post-treatment (OR 1.44, 95% CI 0.83 to 2.49; P = 1.21; 1 study, 214 participants) and very low-certainty evidence that it might not reduce service utilisation at 12 months (MD -448.00 British pounds, 95% CI -1660.83 to 764.83; P = 0.47; 1 study, 225 participants). There was very low-certainty evidence that mindfulness may reduce incidents of physical aggression (MD -2.80, 95% CI -4.37 to -1.23; P < 0.001; 1 study; 34 participants) and low-certainty evidence that MBPBS may reduce incidents of aggression post-treatment (MD -10.27, 95% CI -14.86 to -5.67; P < 0.001, I2 = 87%; 2 studies, 128 participants). Reasons for downgrading the certainty of evidence were risk of bias (particularly selection and performance bias); imprecision (results from single, often small studies, wide CIs, and CIs crossing the null effect); and inconsistency (statistical heterogeneity). Authors' conclusions: There is moderate-certainty evidence that cognitive-behavioural approaches such as anger management and PBS may reduce outwardly directed aggressive behaviour in the short term but there is less certainty about the evidence in the medium and long term, particularly in relation to other outcomes such as quality of life. There is some evidence to suggest that combining more than one intervention may have cumulative benefits. Most studies were small and there is a need for larger, robust randomised controlled trials, particularly for interventions where the certainty of evidence is very low. More trials are needed that focus on children and whether psychological interventions lead to reductions in the use of psychotropic medications.

The Cochrane database of systematic reviews · systematic review · 6 citationsread the source →

Prevention of firearm-related injuries with restrictive licensing and concealed carry laws: An Eastern Association for the Surgery of Trauma systematic review.

Background: In the past decade, more than 300,000 people in the United States have died from firearm injuries. Our goal was to assess the effectiveness of two particular prevention strategies, restrictive licensing of firearms and concealed carry laws, on firearm-related injuries in the US Restrictive Licensing was defined to include denials of ownership for various offenses, such as performing background checks for domestic violence and felony convictions. Concealed carry laws allow licensed individuals to carry concealed weapons. Methods: A comprehensive review of the literature was performed. We used Grading of Recommendations Assessment, Development, and Evaluation methodology to assess the breadth and quality of the data specific to our Population, Intervention, Comparator, Outcomes (PICO) questions. Results: A total of 4673 studies were initially identified, then seven more added after two subsequent, additional literature reviews. Of these, 3,623 remained after removing duplicates; 225 case reports, case series, and reviews were excluded, and 3,379 studies were removed because they did not focus on prevention or did not address our comparators of interest. This left a total of 14 studies which merited inclusion for PICO 1 and 13 studies which merited inclusion for PICO 2. Conclusion: PICO 1: We recommend the use of restrictive licensing to reduce firearm-related injuries.PICO 2: We recommend against the use of concealed carry laws to reduce firearm-related injuries. This committee found an association between more restrictive licensing and lower firearm injury rates. All 14 studies were population-based, longitudinal, used modeling to control for covariates, and 11 of the 14 were multi-state. Twelve of the studies reported reductions in firearm injuries, from 7% to 40%. We found no consistent effect of concealed carry laws. Of note, the varied quality of the available data demonstrates a significant information gap, and this committee recommends that we as a society foster a nurturing and encouraging environment that can strengthen future evidence based guidelines. Level of evidence: Systematic review, level III.

The journal of trauma and acute care surgery · systematic review · 27 citationsread the source →

Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Unhealthy alcohol use is common, increasing, and a leading cause of premature mortality. Objective: To review literature on the effectiveness and harms of screening and counseling for unhealthy alcohol use to inform the US Preventive Services Task Force. Data sources: MEDLINE, PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through October 12, 2017; literature surveillance through August 1, 2018. Study selection: Test accuracy studies and randomized clinical trials of screening and counseling to reduce unhealthy alcohol use. Data extraction and synthesis: Independent critical appraisal and data abstraction by 2 reviewers. Counseling trials were pooled using random-effects meta-analyses. Main outcomes and measures: Sensitivity, specificity, drinks per week, exceeding recommended limits, heavy use episodes, abstinence (for pregnant women), and other health, family, social, and legal outcomes. Results: One hundred thirteen studies (N = 314 466) were included. No studies examined benefits or harms of screening programs to reduce unhealthy alcohol use. For adolescents (10 studies [n = 171 363]), 1 study (n = 225) reported a sensitivity of 0.73 (95% CI, 0.60 to 0.83) and specificity of 0.81 (95% CI, 0.74 to 0.86) using the AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) to detect the full spectrum of unhealthy alcohol use. For adults (35 studies [n = 114 182]), brief screening instruments commonly reported sensitivity and specificity between 0.70 and 0.85. Two trials of the effects of interventions to reduce unhealthy alcohol use in adolescents (n = 588) found mixed results: one reported a benefit in high-risk but not moderate-risk drinkers, and the other reported a statistically significant reduction in drinking frequency for boys but not girls; neither reported health or related outcomes. Across all populations (68 studies [n = 36 528]), counseling interventions were associated with a decrease in drinks per week (weighted mean difference, -1.6 [95% CI, -2.2 to -1.0]; 32 studies [37 effects; n = 15 974]), the proportion exceeding recommended drinking limits (odds ratio [OR], 0.60 [95% CI, 0.53 to 0.67]; 15 studies [16 effects; n = 9760]), and the proportion reporting a heavy use episode (OR, 0.67 [95% CI, 0.58 to 0.77]; 12 studies [14 effects; n = 8108]), and an increase in the proportion of pregnant women reporting abstinence (OR, 2.26 [95% CI, 1.43 to 3.56]; 5 studies [n = 796]) after 6 to 12 months. Health outcomes were sparsely reported and generally did not demonstrate group differences in effect. There was no evidence that these interventions could be harmful. Conclusions and relevance: Among adults, screening instruments feasible for use in primary care are available that can effectively identify people with unhealthy alcohol use, and counseling interventions in those who screen positive are associated with reductions in unhealthy alcohol use. There was no evidence that these interventions have unintended harmful effects.

JAMA · systematic review · 171 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 →

Efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline in Twin Families (VIPP-Twins): Study protocol for a randomized controlled trial.

Background: Intervention programs with the aim of enhancing parenting quality have been found to be differentially effective in decreasing negative child outcomes such as externalizing behavioral problems, resulting in modest overall effect sizes. Here we present the protocol for a randomized controlled trial to examine the efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline for Twin Families (VIPP-Twins) on parenting quality and children's behavioral control and social competence. In addition, we aim to test the differential susceptibility theory; we examine differential efficacy of the intervention based on genetic make-up or temperament for both parents and children. Lastly, we explore neurobiological mechanisms underlying intervention effects on children's developmental outcomes. Methods/design: The original VIPP-SD was adapted for use in families with twins. The VIPP-Twins consists of five biweekly sessions in which the families are visited at home, parent-child interactions are videotaped and parents receive positive feedback on selected video fragments. Families (N = 225) with a same sex twin (mean age = 3.6 years) were recruited to participate in the study. The study consists of four assessments. After two baseline assessments in year 1 and year 2, a random 40 % of the sample will receive the VIPP-Twins program. The first post-test assessment will be carried out one month after the intervention and there will be a long term follow-up assessment two years after the intervention. Measures include observational assessments of parenting and children's social competence and behavioral control, and neurobiological assessments (i.e., hormonal functioning and neural (re-)activity). Discussion: Results of the study will provide insights in the efficacy of the VIPP-Twins and reveal moderators and mediators of program efficacy. Overall the randomized controlled trial is an experimental test of the differential susceptibility theory. Trial registration: Dutch Trial Register: NTR5312 ; Date registered: July 20, 2015.

BMC psychology · randomised controlled trial · 30 citationsread the source →

Efficacy of Smartphone Applications for Smoking Cessation: A Randomized Clinical Trial.

Importance: Smoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy. Objective: To determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG). Design, setting, and participants: A 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant's 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses. Interventions: iCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers. Main outcomes and measures: The primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization. Results: Participants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P < .001). Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001). Conclusions and relevance: This trial provides evidence that, compared with a USCPG-based smartphone application, an ACT-based smartphone application was more efficacious for quitting cigarette smoking and thus can be an impactful treatment option. Trial registration: ClinicalTrials.gov Identifier: NCT02724462.

JAMA internal medicine · randomised controlled trial · 159 citationsread the source →

Iron therapy for improving psychomotor development and cognitive function in children under the age of three with iron deficiency anaemia.

Background: Iron deficiency and iron deficiency anaemia (IDA) are common in young children. It has been suggested that the lack of iron may have deleterious effects on children's psychomotor development and cognitive function. To evaluate the benefits of iron therapy on psychomotor development and cognitive function in children with IDA, a Cochrane review was carried out in 2001. This is an update of that review. Objectives: To determine the effects of iron therapy on psychomotor development and cognitive function in iron deficient anaemic children less than three years of age. Search methods: We searched the following databases in April 2013: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (ICTRP). We also searched the reference lists of review articles and reports, and ran citation searches in the Science Citation Index for relevant studies identified by the primary search. We also contacted key authors. Selection criteria: Studies were included if children less than three years of age with evidence of IDA were randomly allocated to iron or iron plus vitamin C versus a placebo or vitamin C alone, and assessment of developmental status or cognitive function was carried out using standardised tests by observers blind to treatment allocation. Data collection and analysis: Two review authors independently screened titles and abstracts retrieved from the searches and assessed full-text copies of all potentially relevant studies against the inclusion criteria. The same review authors independently extracted data and assessed the risk of bias of the eligible studies. Data were analysed separately depending on whether assessments were performed within one month of beginning iron therapy or after one month. Main results: We identified one eligible study in the update search that had not been included in the original review. In total, we included eight trials. Six trials, including 225 children with IDA, examined the effects of iron therapy on measures of psychomotor development and cognitive function within 30 days of commencement of therapy. We could pool data from five trials. The pooled difference in pre- to post-treatment change in Bayley Scale Psychomotor Development Index (PDI) between iron and placebo groups was -1.25 (95% confidence interval (CI) -4.56 to 2.06, P value = 0.65; I(2) = 33% for heterogeneity, random-effects meta-analysis; low quality evidence) and in Bayley Scale Mental Development Index (MDI) was 1.04 (95% CI -1.30 to 3.39, P value = 0.79; I(2) = 31% for heterogeneity, random-effects meta-analysis; low quality evidence).Two studies, including 160 randomised children with IDA, examined the effects of iron therapy on measures of psychomotor development and cognitive function more than 30 days after commencement of therapy. One of the studies reported the mean number of skills gained after two months of iron therapy using the Denver Developmental Screening Test. The intervention group gained 0.8 (95% CI -0.18 to 1.78, P value = 0.11, moderate quality of evidence) more skills on average than the control group. The other study reported that the difference in pre- to post-treatment change in Bayley Scale PDI between iron-treated and placebo groups after four months was 18.40 (95% CI 10.16 to 26.64, P value < 0.0001; moderate quality evidence) and in Bayley Scale MDI was 18.80 (95% CI 10.17 to 27.43, P value < 0.0001; moderate quality evidence). Authors' conclusions: There is no convincing evidence that iron treatment of young children with IDA has an effect on psychomotor development or cognitive function within 30 days after commencement of therapy. The effect of longer-term treatment remains unclear. There is an urgent need for further large randomised controlled trials with long-term follow-up.

The Cochrane database of systematic reviews · meta-analysis · 52 citationsread the source →

Effectiveness of a self-guided web-based cannabis treatment program: randomized controlled trial.

Background: Self-help strategies offer a promising way to address problems with access to and stigma associated with face-to-face drug and alcohol treatment, and the Internet provides an excellent delivery mode for such strategies. To date, no study has tested the effectiveness of a fully self-guided web-based treatment for cannabis use and related problems. Objectives: The current study was a two-armed randomized controlled trial aimed at testing the effectiveness of Reduce Your Use, a fully self-guided web-based treatment program for cannabis use disorder consisting of 6 modules based on cognitive, motivational, and behavioral principles. Methods: 225 individuals who wanted to cease or reduce their cannabis use were recruited using both online and offline advertising methods and were randomly assigned to receive: (1) the web-based intervention, or (2) a control condition consisting of 6 modules of web-based educational information on cannabis. Assessments of cannabis use, dependence symptoms, and abuse symptoms were conducted through online questionnaires at baseline, and at 6-week and 3-month follow-ups. Two sets of data analyses were undertaken--complier average causal effect (CACE) modeling and intention to treat (ITT). Results: Two thirds (149) of the participants completed the 6-week postintervention assessment, while 122 (54%) completed the 3-month follow-up assessment. Participants in the intervention group completed an average of 3.5 of the 6 modules. The CACE analysis revealed that at 6 weeks, the experimental group reported significantly fewer days of cannabis use during the past month (P=.02), significantly lower past-month quantity of cannabis use (P=.01), and significantly fewer symptoms of cannabis abuse (P=.047) relative to controls. Cannabis dependence symptoms (number and severity) and past-month abstinence did not differ significantly between groups (Ps>.05). Findings at 3 months were similar, except that the experimental group reported significantly fewer and less severe cannabis dependence symptoms (Ps<.05), and past-month quantity of cannabis consumed no longer differed significantly between groups (P=.16). ITT analyses yielded similar outcomes. Conclusion: Findings suggest that web-based interventions may be an effective means of treating uncomplicated cannabis use and related problems and reducing the public health burden of cannabis use disorders. Trial registration: ACTRN12609000856213, Australian New Zealand Clinical Trials Registry.

Journal of medical Internet research · randomised controlled trial · 79 citationsread the source →

Clinical and cost-effectiveness of cognitive behaviour therapy for health anxiety in medical patients: a multicentre randomised controlled trial.

Background: Health anxiety has been treated by therapists expert in cognitive behaviour therapy with some specific benefit in some patients referred to psychological services. Those in hospital care have been less often investigated. Following a pilot trial suggesting efficacy we carried out a randomised study in hospital medical clinics. Methods: We undertook a multicentre, randomised trial on health anxious patients attending cardiac, endocrine, gastroenterological, neurological, and respiratory medicine clinics in secondary care. We included those aged 16-75 years, who satisfied the criteria for excessive health anxiety, and were resident in the area covered by the hospital, were not under investigation for new pathology or too medically unwell to take part. We used a computer-generated random scheme to allocate eligible medical patients to an active treatment group of five-to-ten sessions of adapted cognitive behaviour therapy (CBT-HA group) delivered by hospital-based therapists or to standard care in the clinics. The primary outcome was change in health anxiety symptoms measured by the Health Anxiety Inventory at 1 year and the main secondary hypothesis was equivalence of total health and social care costs over 2 years, with an equivalence margin of £150. Analysis was by intention to treat. The study is registered with controlled-trials.com, ISRCTN14565822. Findings: Of 28,991 patients screened, 444 were randomly assigned to receive either adapted cognitive behaviour therapy (CBT-HA group, 219 participants) or standard care (standard care group, 225), with 205 participants in the CBT-HA group and 212 in the standard care group included in the analyses of the primary endpoints. At 1 year, improvement in health anxiety in the patients in the CBT-HA group was 2·98 points greater than in those in the standard care group (95% CI 1·64-4·33, p<0·0001), and twice as many patients receiving cognitive behaviour therapy achieved normal levels of health anxiety compared with those in the control group (13·9% vs 7·3%; odds ratio 2·15, 95% CI 1·09-4·23, p=0·0273). Similar differences were observed at 6 months and 2 years, and there were concomitant reductions in generalised anxiety and, to a lesser extent, depression. Of nine deaths, six were in the control group; all were due to pre-existing illness. Social functioning or health-related quality of life did not differ significantly between groups. Equivalence in total 2-year costs was not achieved, but the difference was not significant (adjusted mean difference £156, 95% CI -1446 to 1758, p=0·848). Interpretation: This form of adapted cognitive behaviour therapy for health anxiety led to sustained symptomatic benefit over 2 years, with no significant effect on total costs. It deserves wider application in medical care. Funding: National Institute for Health Research Health Technology Assessment Programme.

Lancet (London, England) · randomised controlled trial · 96 citationsread the source →

Teaching Surgery Residents the Skills to Communicate Difficult News to Patient and Family Members: A Literature Review.

Background: Trainees and practicing physicians alike find breaking bad, sad, or difficult news to a patient or family member as one of the most challenging communication tasks they perform. Interpersonal and communication skills are a core competency for resident training. However, in disciplines where technical skills have a major emphasis, such as surgery, the teaching of communication skills may not be a priority. Objective: The objective of our study is to review literature in order to identify best practices and learning modalities used to teach surgery trainees the communication skills regarding delivery of difficult news to patients and family members. Methods: The criteria for inclusion in this literature review were that the study (1) addresses surgeons' training (nontechnical skills) in breaking difficult news to patient and/or families, (2) describes a teaching modality or intervention targeted to teach surgery residents how to deliver difficult news to patient/family, and (3) is published in English. Results: Articles (n = 225) were screened for final eligibility. After discarding duplicates and noneligible studies, and after abstract/full-text review, 18 articles were included in the final analysis. Most studies are single site; address general surgery residents at varying training levels; and include case-specific, outpatient, and intensive care unit (ICU) settings. There is a paucity of studies in the trauma and unexpected death setting. There is a recent trend to use Objective Structured Clinical Examination (OSCE) both to teach and assess communication skills. Variable tools are used to assess this competency as described. Conclusion: Simulation and OSCE format have emerged as modalities of choice both to teach surgery residents how to deliver difficult news and to assess achievement of this competency. There is a gap in the literature regarding teaching and assessing surgery resident communication skills in delivering difficult news after unexpected events in the trauma and operating room settings.

Journal of palliative medicine · review · 29 citationsread the source →

Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery.

Background: Surgery is the cornerstone in curative treatment of colorectal cancer. Unfortunately, surgery itself can adversely affect patient health. 'Enhanced Recovery After Surgery' programmes, which include multimodal interventions, have improved patient outcomes substantially. However, these are mainly applied peri- and postoperatively. Multimodal prehabilitation includes multiple preoperative interventions to prepare patients for surgery with the aim of increasing resilience, thereby improving postoperative outcomes. Objectives: To determine the effects of multimodal prehabilitation programmes on functional capacity, postoperative complications, and quality of life in adult patients undergoing surgery for colorectal cancer. Search methods: We searched CENTRAL, MEDLINE, Embase and PsycINFO in January 2021. We also searched trial registries up to March 2021. Selection criteria: We included randomised controlled trials (RCTs) in adult patients with non-metastatic colorectal cancer, scheduled for surgery, comparing multimodal prehabilitation programmes (defined as comprising at least two preoperative interventions) with no prehabilitation. We focused on the following outcomes: functional capacity (i.e. 6-minute walk test, VO2peak, handgrip strength), postoperative outcomes (i.e. complications, mortality, length of hospital stay, emergency department visits, re-admissions), health-related quality of life, compliance, safety of prehabilitation, and return to normal activities. Data collection and analysis: Two authors independently selected studies, extracted data, assessed risk of bias and used GRADE to assess the certainty of the evidence. Any disagreements were solved with discussion and consensus. We pooled data to perform meta-analyses, where possible. Main results: We included three RCTs that enrolled 250 participants with non-metastatic colorectal cancer, scheduled for elective (mainly laparoscopic) surgery. Included trials were conducted in tertiary care centres and recruited patients during periods ranging from 17 months to 45 months. A total of 130 participants enrolled in a preoperative four-week trimodal prehabilitation programme consisting of exercise, nutritional intervention, and anxiety reduction techniques. Outcomes of these participants were compared to those of 120 participants who started an identical but postoperative programme. Postoperatively, prehabilitation may improve functional capacity, determined with the 6-minute walk test at four and eight weeks (mean difference (MD) 26.02, 95% confidence interval (CI) -13.81 to 65.85; 2 studies; n = 131; and MD 26.58, 95% CI -8.88 to 62.04; 2 studies; n = 140); however, the certainty of evidence is low and very low, respectively, due to serious risk of bias, imprecision, and inconsistency. After prehabilitation, the functional capacity before surgery improved, with a clinically relevant mean difference of 24.91 metres (95% CI 11.24 to 38.57; 3 studies; n = 225). The certainty of evidence was moderate due to downgrading for serious risk of bias. The effects of prehabilitation on the number of complications (RR 0.95, 95% CI 0.70 to 1.29; 3 studies; n = 250), emergency department visits (RR 0.72, 95% CI 0.39 to 1.32; 3 studies; n = 250) and re-admissions (RR 1.20, 95% CI 0.54 to 2.65; 3 studies; n = 250) were small or even trivial. The certainty of evidence was low due to downgrading for serious risk of bias and imprecision. The effects on VO2peak, handgrip strength, length of hospital stay, mortality rate, health-related quality of life, return to normal activities, safety of the programme, and compliance rate could not be analysed quantitatively due to missing or insufficient data. The included studies did not report a difference between groups for health-related quality of life and length of hospital stay. Data on remaining outcomes were not reported or were reported inadequately in the included studies. Authors' conclusions: Prehabilitation may result in an improved functional capacity, determined with the 6-minute walk test both preoperatively and postoperatively. A solid effect on the number of omplications, postoperative emergency department visits and re-admissions could not be established. The certainty of evidence ranges from moderate to very low, due to downgrading for serious risk of bias, imprecision and inconsistency. In addition, only three heterogeneous studies were included in this review. Therefore, the findings of this review should be interpreted with caution. Numerous relevant RCTs are ongoing and will be included in a future update of this review.

The Cochrane database of systematic reviews · review · 55 citationsread the source →

Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery.

Background: Surgery is the cornerstone in curative treatment of colorectal cancer. Unfortunately, surgery itself can adversely affect patient health. 'Enhanced Recovery After Surgery' programmes, which include multimodal interventions, have improved patient outcomes substantially. However, these are mainly applied peri- and postoperatively. Multimodal prehabilitation includes multiple preoperative interventions to prepare patients for surgery with the aim of increasing resilience, thereby improving postoperative outcomes. Objectives: To determine the effects of multimodal prehabilitation programmes on functional capacity, postoperative complications, and quality of life in adult patients undergoing surgery for colorectal cancer. Search methods: We searched CENTRAL, MEDLINE, Embase and PsycINFO in January 2021. We also searched trial registries up to March 2021. Selection criteria: We included randomised controlled trials (RCTs) in adult patients with non-metastatic colorectal cancer, scheduled for surgery, comparing multimodal prehabilitation programmes (defined as comprising at least two preoperative interventions) with no prehabilitation. We focused on the following outcomes: functional capacity (i.e. 6-minute walk test, VO2peak, handgrip strength), postoperative outcomes (i.e. complications, mortality, length of hospital stay, emergency department visits, re-admissions), health-related quality of life, compliance, safety of prehabilitation, and return to normal activities. Data collection and analysis: Two authors independently selected studies, extracted data, assessed risk of bias and used GRADE to assess the certainty of the evidence. Any disagreements were solved with discussion and consensus. We pooled data to perform meta-analyses, where possible. Main results: We included three RCTs that enrolled 250 participants with non-metastatic colorectal cancer, scheduled for elective (mainly laparoscopic) surgery. Included trials were conducted in tertiary care centres and recruited patients during periods ranging from 17 months to 45 months. A total of 130 participants enrolled in a preoperative four-week trimodal prehabilitation programme consisting of exercise, nutritional intervention, and anxiety reduction techniques. Outcomes of these participants were compared to those of 120 participants who started an identical but postoperative programme. Postoperatively, prehabilitation may improve functional capacity, determined with the 6-minute walk test at four and eight weeks (mean difference (MD) 26.02, 95% confidence interval (CI) -13.81 to 65.85; 2 studies; n = 131; and MD 26.58, 95% CI -8.88 to 62.04; 2 studies; n = 140); however, the certainty of evidence is low and very low, respectively, due to serious risk of bias, imprecision, and inconsistency. After prehabilitation, the functional capacity before surgery improved, with a clinically relevant mean difference of 24.91 metres (95% CI 11.24 to 38.57; 3 studies; n = 225). The certainty of evidence was moderate due to downgrading for serious risk of bias. Prehabilitation may also result in fewer complications (RR 0.95, 95% CI 0.70 to 1.29; 3 studies; n = 250) and fewer emergency department visits (RR 0.72, 95% CI 0.39 to 1.32; 3 studies; n = 250). The certainty of evidence was low due to downgrading for serious risk of bias and imprecision. On the other hand, prehabilitation may also result in a higher re-admission rate (RR 1.20, 95% CI 0.54 to 2.65; 3 studies; n = 250). The certainty of evidence was again low due to downgrading for risk of bias and imprecision. The effect on VO2peak, handgrip strength, length of hospital stay, mortality rate, health-related quality of life, return to normal activities, safety of the programme, and compliance rate could not be analysed quantitatively due to missing or insufficient data. The included studies did not report a difference between groups for health-related quality of life and length of hospital stay. Data on remaining outcomes were not reported or were reported inadequately in the included studies. Authors' conclusions: Prehabilitation may result in an improved functional capacity, determined with the 6-minute walk test both preoperatively and postoperatively. Complication rates and the number of emergency department visits postoperatively may also diminish due to a prehabilitation programme, while the number of re-admissions may be higher in the prehabilitation group. The certainty of evidence ranges from moderate to very low, due to downgrading for serious risk of bias, imprecision and inconsistency. In addition, only three heterogeneous studies were included in this review. Therefore, the findings of this review should be interpreted with caution. Numerous relevant RCTs are ongoing and will be included in a future update of this review.

The Cochrane database of systematic reviews · systematic review · 86 citationsread the source →

Negative emotions and behaviour: The role of regulatory emotional self-efficacy.

The objective of this study is to test a longitudinal model that analyses the direct effect of negative emotions (anger, depression and anxiety, wave 1) on prosocial and aggressive behaviour (wave 2) in adolescents. And the indirect effect of negative emotions (wave 1) on prosocial and aggressive behaviour (wave 2) through regulatory emotional self-efficacy. Data was obtained from 417 adolescents in a two-wave longitudinal study (225 girls, M age = 14.70 years) from schools located in Valencia, Spain. SEM was employed to explore longitudinal models. The results showed that anger had a direct relationship with prosocial behaviour and aggression, measured two years later. However, the depression and anxiety states did not predict prosociality and aggressiveness. The mediation role of regulatory emotional self-efficacy between negative emotion and behaviours was only partially confirmed. Finally, only the perception of self-efficacy in expressing positive affect is related to prosociality and aggressiveness.

Journal of adolescence · 42 citationsread the source →

Goal adjustment influence on psychological well-being following advanced breast cancer diagnosis.

Objective: A diagnosis of advanced breast cancer (ABC) challenges a woman's ambitions. This longitudinal study explored (1) if goal adjustment disposition influenced psychological adjustment patterns among women with ABC and (2) if dispositional hope and optimism moderate effects of goal adjustment on psychological adjustment. Methods: One hundred ninety three out of 225 women with ABC were assessed while they were awaiting/receiving initial chemotherapy, then again at 6 weeks, 3 months, 6 months, and 12 months post-baseline. Goal disengagement, goal reengagement, optimism, hope, and psychological adjustment (anxiety, depression, and positive affect) were assessed at baseline; psychological adjustment was reassessed at each follow-up. Latent growth curve modeling was used to examine the change of psychological adjustment and test the study objectives. Results: High goal disengagement, low reengagement, and high optimism were associated with lower initial anxiety, while high goal disengagement and optimism predicted a slower rate of change in anxiety. High goal disengagement, reengagement, and optimism were associated with lower initial depression. High goal reengagement, optimism, and hope were associated with initial positive affect scores, while optimism predicted its rate of change. Optimism moderated the effect of goal disengagement on anxiety and depression, whereas hope moderated the effect of goal reengagement on positive affect. Conclusion: Goal disengagement and reengagement are two relatively independent processes influencing psychological well-being. These findings will help clinicians to tailor specific interventions to help women coping with the diagnosis of ABC.

Psycho-oncology · 22 citationsread the source →

Unpacking Profiles of School Burnout in High-Achieving Students in Türkiye: A MSEM Analysis.

Although high-achieving students are often perceived as well-adjusted, there is limited understanding of the varied ways they experience school burnout. Prior research tends to treat burnout as a uniform phenomenon, overlooking subgroups that may differ in psychological risk and academic outcomes. This study addresses this gap by identifying distinct profiles of school burnout and examining their psychological and academic correlates in high-achieving adolescents, defined by their mean grade of 85 or above out of 100 and placement in the top 2%, which earned them admission to science high schools based on their performance on Türkiye's High School Entrance Exam (LGS). Participants included 443 students (225 females, 50.8%) aged 14 to 19 years (M = 15.9, SD = 1.11). Given the broad age range spanning early to late adolescence, developmental variability in academic expectations and emotional regulation is likely, which may influence how students experience burnout. Using Mixture Structural Equation Modeling (MSEM), in which latent profiles and structural pathways were estimated simultaneously, the study found that parental achievement pressure, self-oriented perfectionism, and socially prescribed perfectionism predicted fear of failure, which in turn negatively impacted grade point average. Both fear of failure and grade point average were significant predictors of burnout, with fear increasing burnout and grade point average serving as a protective factor. Latent Profile Analysis revealed three distinct student profiles: "Calm but Underachieving", "Burnout Under Pressure", and "Self-Driven High Achiever". Three-step regression analyses revealed that psychological symptoms varied meaningfully across profiles. Specifically, the "Calm but Underachieving" group had significantly higher odds of depression compared to the "Self-Driven High Achiever" group, despite reporting lower stress levels. Meanwhile, anxiety levels did not significantly differ across any profile, indicating that anxiety may be a more generalized emotional response among students regardless of their academic engagement. These findings underscore the importance of considering developmental differences and psychological risks unique to high-achieving adolescents. By identifying distinct burnout profiles, this study provides nuanced insights that address gaps in current understanding and support the development of targeted mental health interventions for high-achieving adolescents.

Journal of youth and adolescenceread the source →

Mediating role of social skills in the longitudinal relationship between intrapersonal perfectionism and psychological well-being of preadolescents.

Intrapersonal perfectionism is the dispositional tendency to impose perfectionistic expectations on oneself and is considered a bidimensional construct that consists of standards perfectionism and discrepancy perfectionism. Although scholars established the links between standards perfectionism and psychological adjustment and between discrepancy perfectionism and psychopathology, the mechanisms that explain these associations remain relatively unknown. Thus, a better understanding of these mechanisms, especially in children, is warranted given their high prevalence in this developmental population and potential destructiveness on psychological well-being. The present study examined whether social skills with peers mediated the link between the dimensions of interpersonal perfectionism and psychological outcomes due to the salience of social skills acquisition in middle childhood. The study included 225 students (nfemale = 114; nmale = 111) with ages ranging from 7 to 10 years at Time 1 (T1; Mage = 8.55, SD = 1.15) and from 8 to 11 years at Time 2 (T2; Mage = 9.52, SD = 1.10). Participants provided responses on measures concerning standards perfectionism, discrepancy perfectionism, social skills, and psychological well-being at both time points. Longitudinal structural equation modeling indicated that standards perfectionism was positively associated with increases in social skills over time and psychological well-being, whereas discrepancy perfectionism was linked with decreases in social skills over time followed by psychological maladjustment. The study discusses implications for interventions and treatments.

Journal of school psychologyread the source →

Using Participatory Design Methodologies to Co-Design and Culturally Adapt the Spanish Version of the Mental Health eClinic: Qualitative Study.

Background: The Mental Health eClinic (MHeC) aims to deliver best-practice clinical services to young people experiencing mental health problems by making clinical care accessible, affordable, and available to young people whenever and wherever they need it most. The original MHeC consists of home page with a visible triage system for those requiring urgent help; a online physical and mental health self-report assessment; a results dashboard; a booking and videoconferencing system; and the generation of a personalized well-being plan. Populations who do not speak English and reside in English-speaking countries are less likely to receive mental health care. In Australia, international students have been identified as disadvantaged compared with their peers; have weaker social support networks; and have higher rates of psychological distress. This scenario is acquiring significant relevance as Spanish-speaking migration is rapidly growing in Australia, and the mental health services for culturally and linguistically diverse populations are limited. Having a Spanish version (MHeC-S) of the Mental Health eClinic would greatly benefit these students. Objective: We used participatory design methodologies with users (young people aged 16-30 years, supportive others, and health professionals) to (1) conduct workshops with users to co-design and culturally adapt the MHeC; (2) inform the development of the MHeC-S alpha prototype; (3) test the usability of the MHeC-S alpha prototype; (4) translate, culturally adapt, and face-validate the MHeC-S self-report assessment; and (5) collect information to inform its beta prototype. Methods: A research and development cycle included several participatory design phases: co-design workshops; knowledge translation; language translation and cultural adaptation; and rapid prototyping and user testing of the MHeC-S alpha prototype. Results: We held 2 co-design workshops with 17 users (10 young people, 7 health professionals). A total of 15 participated in the one-on-one user testing sessions (7 young people, 5 health professionals, 3 supportive others). We collected 225 source documents, and thematic analysis resulted in 5 main themes (help-seeking barriers, technology platform, functionality, content, and user interface). A random sample of 106 source documents analyzed by 2 independent raters revealed almost perfect agreement for functionality (kappa=.86; P<.001) and content (kappa=.92; P<.001) and substantial agreement for the user interface (kappa=.785; P<.001). In this random sample, no annotations were coded for help-seeking barriers or the technology platform. Language was identified as the main barrier to getting medical or psychological services, and smartphones were the most-used device to access the internet. Acceptability was adequate for the prototype's 5 main elements: home page and triage system, self-report assessment, dashboard of results, booking and video visit system, and personalized well-being plan. The data also revealed gaps in the alpha prototype, such as the need for tailored assessment tools and a greater integration with Spanish-speaking services and communities. Spanish-language apps and e-tools, as well as online mental health information, were lacking. Conclusions: Through a research and development process, we co-designed and culturally adapted, developed and user tested, and evaluated the MHeC-S. By translating and culturally adapting the MHeC to Spanish, we aimed to increase accessibility and availability of e-mental health care in the developing world, and assist vulnerable populations that have migrated to English-speaking countries.

Journal of medical Internet research · 58 citationsread the source →

Work-Family Guilt in Spanish Parents: Analysis of the Measurement, Antecedents and Outcomes from a Gender Perspective.

This research work had three objectives: (1) to analyze the psychometric properties of the Spanish version of the Work-Family Guilt Scale, (2) to examine its invariance according to gender, and (3) to study the relationship between work-family guilt (WFG) and the different proposed antecedent (e.g., hours spent working, social support, rumination, and personality) or consequential factors (e.g., life satisfaction), noting any gender differences. The incidental sample comprised 225 parents who were in paid work and had at least one child attending nursery school (49.1% women; age of total sample = 36.88 on average). Multiple-group and confirmatory factor analyses, correlations, multiple regression, and moderation analyses were carried out. The WFGS reflected the same factorial structure in men and women, with two main factors: work interfering with family guilt (WIFG) and family interfering with work guilt (FIWG). No gender differences were found. The discrepancy associated with perfectionism was the only variable that was found to be a predictor of FIWG. The major predictors of WIFG were brooding from rumination and the number of hours spent working. WIFG was also associated with lower life satisfaction in women. The implications of these results are discussed, stressing the need to promote work-family reconciliation policies.

International journal of environmental research and public health · 4 citationsread the source →

Cost effectiveness and cost-utility analysis of a group-based diet intervention for treating major depression - the HELFIMED trial.

Background/objectives: Major depression has a negative impact on quality of life, increasing the risk of premature death. It imposes social and economic costs on individuals, families and society. Mental illness is now the leading cause globally of disability/lost quality life and premature mortality. Finding cost-effective treatments for depression is a public health priority. We report an economic evaluation of a dietary intervention for treating major depression. Methods: This economic evaluation drew on the HELFIMED RCT, a 3-month group-based Mediterranean-style diet (MedDiet) intervention (including cooking workshops), against a social group-program for people with major depression. We conducted (i) a cost-utility analysis, utility scores measured at baseline, 3-months and 6-months using the AQoL8D, modelled to 2 years (base case); (ii) a cost-effectiveness analysis, differential cost/case of depression resolved (to normal/mild) measured by the DASS. Differential program costs were calculated from resources use costed in AUD2017. QALYs were discounted at 3.5%pa. Results: Best estimate differential cost/QALY gain per person, MedDiet relative to social group was AUD2775. Probabilistic sensitivity analysis, varying costs, utility gain, model period found 95% likelihood cost/QALY less than AUD20,000. Estimated cost per additional case of depression resolved, MedDiet group relative to social group was AUD2,225. Conclusions: A MedDiet group-program for treating major depression was highly cost-effective relative to a social group-program, measured in terms of cost/QALY gain and cost per case of major depression resolved. Supporting access by persons with major depression to group-based dietary programs should be a policy priority. A change to funding will be needed to realise the potential benefits.

Nutritional neuroscience · 27 citationsread the source →

Cervical cancer screening practices among women in Ghana: evidence from wave 2 of the WHO study on global AGEing and adult health.

Background: Cervical cancer is the third most common cancer that affects women worldwide. It has been and remains the leading cause of cancer mortality among women in Ghana. Despite the fact that cervical cancer is preventable through early detection and treatment of precancerous lesions, anecdotal evidence from gynaecological clinics in Ghana indicates that most patients present with a late stage of the disease. This study assesses the cervical cancer screening practices among women in Ghana. Methods: Data from the World Health Organization's (WHO) multi-country Study on AGEing and adult health (SAGE) wave 2 conducted between 2014 and 2015 in Ghana was used. We employed binary logistic regression models to analyse data on 2711 women to examine factors associated with having pelvic examination among women aged ≥18 years. Among those who had pelvic examination, we applied binary logistic regression models to analyse factors associated with receiving Pap smear test as a subgroup analysis. Results: Of the 2711 women aged 18 years or older surveyed, 225 (8.3%) had ever had a pelvic examination and only 66 (2.4%) of them reported ever having done a Pap smear test. For those who had pelvic examination, only 26.94% had Pap smear test. Ethnic group, marital status, father's educational level and difficulty with self-care were independently associated with undergoing pelvic examination. Only age and healthcare involvement were independently associated with pelvic examination within the past 5 years to the survey. Marital status, satisfaction with healthcare and healthcare involvement were independently associated with Pap smear test. Conclusion: Even though cervical cancer is preventable through early detection of precancerous lesions using Pap smear test, the patronage of this screening test is still very low in Ghana. Factors influencing the low patronage in Ghana include the marital status of women, their level of satisfaction with healthcare as well as their level of involvement with healthcare. These may be the consequences of a weak health system and the lack of a national policy on cervical cancer screening.

BMC women's health · 55 citationsread the source →

Intrinsic, identified, and controlled types of motivation for school subjects in young elementary school children

BACKGROUND: There are two approaches to the differential examination of school motivation. The first is to examine motivation towards specific school subjects (between school subject differentiation). The second is to examine school motivation as a multidimensional concept that varies in terms of not only intensity but also quality (within school subject differentiation). These two differential approaches have led to important discoveries and provided a better understanding of student motivational dynamics. However, little research has combined these two approaches. AIMS: This study examines young elementary students' motivations across school subjects (writing, reading, and maths) from the stance of self-determination theory. First, we tested whether children self-report different levels of intrinsic, identified, and controlled motivation towards specific school subjects. Second, we verified whether children self-report differentiated types of motivation across school subjects. SAMPLE: Participants were 425 French-Canadian children (225 girls, 200 boys) from three elementary schools. Children were in Grades 1 (N=121), 2 (N=126), and 3 (N=178). RESULTS: Results show that, for a given school subject, young elementary students self-report different levels of intrinsic, identified, and controlled motivation. Results also indicate that children self-report different levels of motivation types across school subjects. Our findings also show that most differentiation effects increase across grades. Some gender effects were also observed. CONCLUSION: These results highlight the importance of distinguishing among types of school motivation towards specific school subjects in the early elementary years.

British Journal of Educational Psychology · 554 citationsread the source →