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Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.

Background: Obesity is associated with a reduction in life expectancy and an increase in mortality from cardiovascular diseases, cancer, and other causes. We therefore assessed the efficacy and safety of two doses of phentermine plus topiramate controlled-release combination as an adjunct to diet and lifestyle modification for weight loss and metabolic risk reduction in individuals who were overweight and obese, with two or more risk factors. Methods: In this 56-week phase 3 trial, we randomly assigned overweight or obese adults (aged 18-70 years), with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) to placebo, once-daily phentermine 7·5 mg plus topiramate 46·0 mg, or once-daily phentermine 15·0 mg plus topiramate 92·0 mg in a 2:1:2 ratio in 93 centres in the USA. Drugs were administered orally. Patients were randomly assigned by use of a computer-generated algorithm that was implemented through an interactive voice response system, and were stratified by sex and diabetic status. Investigators, patients, and study sponsors were masked to treatment. Primary endpoints were the percentage change in bodyweight and the proportion of patients achieving at least 5% weight loss. Analysis was by intention to treat. This study is registered with Clinical Trials.gov, number NCT00553787. Findings: Of 2487 patients, 994 were assigned to placebo, 498 to phentermine 7·5 mg plus topiramate 46·0 mg, and 995 to phentermine 15·0 mg plus topiramate 92·0 mg; 979, 488, and 981 patients, respectively, were analysed. At 56 weeks, change in bodyweight was -1·4 kg (least-squares mean -1·2%, 95% CI -1·8 to -0·7), -8·1 kg (-7·8%, -8·5 to -7·1; p<0·0001), and -10·2 kg (-9·8%, -10·4 to -9·3; p<0·0001) in the patients assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively. 204 (21%) patients achieved at least 5% weight loss with placebo, 303 (62%; odds ratio 6·3, 95% CI 4·9 to 8·0; p<0·0001) with phentermine 7·5 mg plus topiramate 46·0 mg, and 687 (70%; 9·0, 7·3 to 11·1; p<0·0001) with phentermine 15·0 mg plus topiramate 92·0 mg; for ≥10% weight loss, the corresponding numbers were 72 (7%), 182 (37%; 7·6, 5·6 to 10·2; p<0·0001), and 467 (48%; 11·7, 8·9 to 15·4; p<0·0001). The most common adverse events were dry mouth (24 [2%], 67 [13%], and 207 [21%] in the groups assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively), paraesthesia (20 [2%], 68 [14%], and 204 [21%], respectively), constipation (59 [6%], 75 [15%], and 173 [17%], respectively), insomnia (47 [5%], 29 [6%], and 102 [10%], respectively), dizziness (31 [3%], 36 [7%], 99 [10%], respectively), and dysgeusia (11 [1%], 37 [7%], and 103 [10%], respectively). 38 (4%) patients assigned to placebo, 19 (4%) to phentermine 7·5 mg plus topiramate 46·0 mg, and 73 (7%) to phentermine 15·0 mg plus topiramate 92·0 mg had depression-related adverse events; and 28 (3%), 24 (5%), and 77 (8%), respectively, had anxiety-related adverse events. Interpretation: The combination of phentermine and topiramate, with office-based lifestyle interventions, might be a valuable treatment for obesity that can be provided by family doctors. Funding: Vivus.

Lancet (London, England) · randomised controlled trial · 667 citationsread the source →

Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: a randomized controlled trial.

Purpose: The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer. Patients and methods: Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27. Results: Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period. Conclusion: Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 244 citationsread the source →

Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial.

Background: Treatment-resistant major depressive disorder is common; repetitive transcranial magnetic stimulation (rTMS) by use of high-frequency (10 Hz) left-side dorsolateral prefrontal cortex stimulation is an evidence-based treatment for this disorder. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered in 3 min, versus 37·5 min for a standard 10 Hz treatment session. We aimed to establish the clinical effectiveness, safety, and tolerability of iTBS compared with standard 10 Hz rTMS in adults with treatment-resistant depression. Methods: In this randomised, multicentre, non-inferiority clinical trial, we recruited patients who were referred to specialty neurostimulation centres based at three Canadian university hospitals (Centre for Addiction and Mental Health and Toronto Western Hospital, Toronto, ON, and University of British Columbia Hospital, Vancouver, BC). Participants were aged 18-65 years, were diagnosed with a current treatment-resistant major depressive episode or could not tolerate at least two antidepressants in the current episode, were receiving stable antidepressant medication doses for at least 4 weeks before baseline, and had an HRSD-17 score of at least 18. Participants were randomly allocated (1:1) to treatment groups (10 Hz rTMS or iTBS) by use of a random permuted block method, with stratification by site and number of adequate trials in which the antidepressants were unsuccessful. Treatment was delivered open-label but investigators and outcome assessors were masked to treatment groups. Participants were treated with 10 Hz rTMS or iTBS to the left dorsolateral prefrontal cortex, administered on 5 days a week for 4-6 weeks. The primary outcome measure was change in 17-item Hamilton Rating Scale for Depression (HRSD-17) score, with a non-inferiority margin of 2·25 points. For the primary outcome measure, we did a per-protocol analysis of all participants who were randomly allocated to groups and who attained the primary completion point of 4 weeks. This trial is registered with ClinicalTrials.gov, number NCT01887782. Findings: Between Sept 3, 2013, and Oct 3, 2016, we randomly allocated 205 participants to receive 10 Hz rTMS and 209 participants to receive iTBS. 192 (94%) participants in the 10 Hz rTMS group and 193 (92%) in the iTBS group were assessed for the primary outcome after 4-6 weeks of treatment. HRSD-17 scores improved from 23·5 (SD 4·4) to 13·4 (7·8) in the 10 Hz rTMS group and from 23·6 (4·3) to 13·4 (7·9) in the iTBS group (adjusted difference 0·103 [corrected], lower 95% CI -1·16; p=0·0011), which indicated non-inferiority of iTBS. Self-rated intensity of pain associated with treatment was greater in the iTBS group than in the 10 Hz rTMS group (mean score on verbal analogue scale 3·8 [SD 2·0] vs 3·4 [2·0] out of 10; p=0·011). Dropout rates did not differ between groups (10 Hz rTMS: 13 [6%] of 205 participants; iTBS: 16 [8%] of 209 participants); p=0·6004). The most common treatment-related adverse event was headache in both groups (10 Hz rTMS: 131 [64%] of 204; iTBS: 136 [65%] of 208). Interpretation: In patients with treatment-resistant depression, iTBS was non-inferior to 10 Hz rTMS for the treatment of depression. Both treatments had low numbers of dropouts and similar side-effects, safety, and tolerability profiles. By use of iTBS, the number of patients treated per day with current rTMS devices can be increased several times without compromising clinical effectiveness. Funding: Canadian Institutes of Health Research.

Lancet (London, England) · randomised controlled trial · 938 citationsread the source →

Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial.

Background/objectives: Dementia-related behavioral symptoms and functional dependence result in poor quality of life for persons with dementia and their caregivers. The goal was to determine whether a home-based activity program (Tailored Activity Program; TAP-VA) would reduce behavioral symptoms and functional dependence of veterans with dementia and caregiver burden. Design: Single-blind (interviewer), parallel, randomized, controlled trial (Clinicaltrials.gov: NCT01357564). Setting: Veteran's homes. Participants: Veterans with dementia and their family caregivers (N = 160 dyads). Intervention: Dyads in TAP-VA underwent 8 sessions with occupational therapists to customize activities to the interests and abilities of the veterans and educate their caregivers about dementia and use of customized activity. Caregivers assigned to attention control received up to 8 telephone-based dementia education sessions with a research team member. Measurements: Primary outcomes included number of behaviors and frequency of their occurrence multiplied by severity of occurrence; secondary outcomes were functional dependence, pain, emotional well-being, caregiver burden (time spent caregiving, upset with behaviors) and affect at 4 (primary endpoint) and 8 months. Results: Of 160 dyads (n = 76 TAP-VA; n = 84 control), 111 completed 4-month interviews (n = 51 TAP-VA; n = 60 control), and 103 completed 8-month interviews (n = 50 TAP-VA; n = 53 control). At 4 months, compared to controls, the TAP-VA group showed reductions in number (difference in mean change from baseline = -0.68, 95% CI = -1.23 to -0.13) and frequency by severity (-24.3, 95% CI = -45.6 to -3.1) of behavioral symptoms, number of activities needing assistance with (-0.80, 95% CI = -1.41 to -0.20), functional dependence level (4.09, 95% CI = 1.06, 7.13), and pain (-1.18, 95% CI = -2.10 to -0.26). Caregivers of veterans in TAP-VA reported less behavior-related distress. Benefits did not extend to 8 months. Conclusion: TAP-VA had positive immediate effects and no adverse events. Because TAP-VA reduces behavioral symptoms, slows functional dependence, and alleviates pain and caregiver distress, it is a viable treatment option for families.

Journal of the American Geriatrics Society · randomised controlled trial · 70 citationsread the source →

Advocacy interventions to reduce or eliminate violence and promote the physical and psychosocial well-being of women who experience intimate partner abuse.

Background: Intimate partner abuse is common worldwide, damaging the short- and long-term physical, mental, and emotional health of survivors and children. Advocacy may contribute to reducing abuse, empowering women to improve their situation by providing informal counselling and support for safety planning and increasing access to different services. Advocacy may be a stand-alone service, accepting referrals from healthcare providers, or part of a multi-component (and possibly multi-agency) intervention provided by service staff or others. Objectives: To assess the effects of advocacy interventions within or outside healthcare settings in women who have experienced intimate partner abuse. Search methods: In April 2015, we searched CENTRAL, Ovid MEDLINE, EMBASE, and 10 other databases. We also searched WHO ICTRP, mRCT, and UK Clinical Research Network (UKCRN), and examined relevant websites and reference lists with forward citation tracking of included studies. For the original review we handsearched six key journals. We also contacted first authors of eligible papers and experts in the field. Selection criteria: Randomised or quasi-randomised controlled trials comparing advocacy interventions for women with experience of intimate partner abuse versus no intervention or usual care (if advocacy was minimal and fewer than 20% of women received it). Data collection and analysis: Two review authors independently assessed risk of bias and undertook data extraction. We contacted authors for missing information needed to calculate statistics for the review and looked for adverse events. Main results: We included 13 trials involving 2141 participants aged 15 to 65 years, frequently having low socioeconomic status. The studies were quite heterogeneous in terms of methodology, study processes and design, including with regard to the duration of follow-up (postintervention to three years), although this was not associated with differences in effect. The studies also had considerable clinical heterogeneity in relation to staff delivering advocacy; setting (community, shelter, antenatal, healthcare); advocacy intensity (from 30 minutes to 80 hours); and abuse severity. Three trials evaluated advocacy within multi-component interventions. Eleven measured some form of abuse (eight scales), six assessed quality of life (three scales), and six measured depression (three scales). Countries and ethnic groups varied (one or more minority ethnic groups in the USA or UK, and local populations in Hong Kong and Peru). Setting was associated with intensity and duration of advocacy. Risk of bias was high in five studies, moderate in five, and low in three. The quality of evidence (considering multiple factors such as risk of bias, study size, missing data) was moderate to low for brief advocacy and very low for intensive advocacy. Incidence of abuse Physical abuseModerate quality pooled data from two healthcare studies (moderate risk of bias) and one community study (low risk of bias), all with 12-month follow-up data, showed no effect on physical abuse for brief (< 12 hours) advocacy interventions (standardised mean difference (SMD) 0.00, 95% confidence interval (CI) - 0.17 to 0.16; n = 558). One antenatal study (low risk of bias) showed an association between brief advocacy and reduced minor physical abuse at one year (mean difference (MD) change - 1.00, 95% CI - 1.82 to - 0.18; n = 110). An antenatal, multi-component study showed a greater likelihood of physical abuse ending (odds ratio (OR) 0.42, 95% CI 0.23 to 0.75) immediately after advocacy (number needed to treat (NNT) = 8); we cannot exclude impact from other components. Low to very low quality evidence from two intensive advocacy trials (12 hours plus duration) showed reduced severe physical abuse in women leaving a shelter at 24 months (OR 0.39, 95% CI 0.20 to 0.77; NNT = 8), but not at 12 or 36 months. Sexual abuseMeta-analysis of two studies (n = 239) showed no effect of advocacy on sexual abuse (SMD - 0.12, 95% CI - 0.37 to 0.14), agreeing with the change score (MD - 0.07, 95% CI - 0.30 to 0.16) from a third study and the OR (0.96, 95% CI 0.44 to 2.12) from a fourth antenatal, multi-component study. Emotional abuseOne study in antenatal care, rated at low risk of bias, showed reduced emotional abuse at ≤ 12-month follow-up (MD (change score) - 4.24, 95% CI - 6.42 to - 2.06; n = 110). Psychosocial health Quality of lifeMeta-analysis of two studies (high risk of bias) showed intensive advocacy slightly improved overall quality of life of women recruited from shelters (MD 0.23, 95% CI 0.00 to 0.46; n = 343) at 12-month follow-up, with greater improvement in perceived physical quality of life from a primary care study (high risk of bias; MD 4.90, 95% CI 0.98 to 8.82) immediately postintervention. Depression Meta-analysis of two studies in healthcare settings, one at high risk of bias and one at moderate risk, showed that fewer women developed depression (OR 0.31, 95% CI 0.15 to 0.65; n = 149; NNT = 4) with brief advocacy. One study at high risk of bias reported a slight reduction in depression in pregnant women immediately after the intervention (OR 0.51, 95% CI 0.20 to 1.29; n = 103; NNT = 8).There was no evidence that intensive advocacy reduced depression at ≤ 12-month follow-up (MD - 0.14, 95% CI - 0.33 to 0.05; 3 studies; n = 446) or at two years (SMD - 0.12, 95% CI - 0.36 to 0.12; 1 study; n = 265). Adverse effectsTwo women died, one who was murdered by her partner and one who committed suicide. No evidence links either death to study participation. Authors' conclusions: Results suggest some benefits from advocacy. However, most studies were underpowered. Clinical and methodological heterogeneity largely precluded pooling of trials. Therefore, there is uncertainty about the magnitude of benefit, the impact of abuse severity, and the setting. Based on the evidence reviewed, intensive advocacy may improve short-term quality of life and reduce physical abuse one to two years after the intervention for women recruited from domestic violence shelters or refuges. Brief advocacy may provide small short-term mental health benefits and reduce abuse, particularly in pregnant women and for less severe abuse.

The Cochrane database of systematic reviews · meta-analysis · 114 citationsread the source →

Exercise training for bronchiectasis.

Background: Bronchiectasis is characterised by excessive sputum production, chronic cough, and acute exacerbations and is associated with symptoms of dyspnoea and fatigue, which reduce exercise tolerance and impair quality of life. Exercise training in isolation or in conjunction with other interventions is beneficial for people with other respiratory diseases, but its effects in bronchiectasis have not been well established. Objectives: To determine effects of exercise training compared to usual care on exercise tolerance (primary outcome), quality of life (primary outcome), incidence of acute exacerbation and hospitalisation, respiratory and mental health symptoms, physical function, mortality, and adverse events in people with stable or acute exacerbation of bronchiectasis. Search methods: We identified trials from the Cochrane Airways Specialised Register, ClinicalTrials.gov, and the World Health Organization trials portal, from their inception to October 2020. We reviewed respiratory conference abstracts and reference lists of all primary studies and review articles for additional references. Selection criteria: We included randomised controlled trials in which exercise training of at least four weeks' duration (or eight sessions) was compared to usual care for people with stable bronchiectasis or experiencing an acute exacerbation. Co-interventions with exercise training including education, respiratory muscle training, and airway clearance therapy were permitted if also applied as part of usual care. Data collection and analysis: Two review authors independently screened and selected trials for inclusion, extracted outcome data, and assessed risk of bias. We contacted study authors for missing data. We calculated mean differences (MDs) using a random-effects model. We used the GRADE approach to assess the certainty of evidence. Main results: We included six studies, two of which were published as abstracts, with a total of 275 participants. Five studies were undertaken with people with clinically stable bronchiectasis, and one pilot study was undertaken post acute exacerbation. All studies included co-interventions such as instructions for airway clearance therapy and/or breathing strategies, provision of an educational booklet, and delivery of educational sessions. The duration of training ranged from six to eight weeks, with a mix of supervised and unsupervised sessions conducted in the outpatient or home setting. No studies of children were included in the review; however we identified two studies as currently ongoing. No data were available regarding physical activity levels or adverse events. For people with stable bronchiectasis, evidence suggests that exercise training compared to usual care improves functional exercise tolerance as measured by the incremental shuttle walk distance, with a mean difference (MD) between groups of 87 metres (95% confidence interval (CI) 43 to 132 metres; 4 studies, 161 participants; low-certainty evidence). Evidence also suggests that exercise training improves six-minute walk distance (6MWD) (MD between groups of 42 metres, 95% CI 22 to 62; 1 study, 76 participants; low-certainty evidence). The magnitude of these observed mean changes appears clinically relevant as they exceed minimal clinically important difference (MCID) thresholds for people with chronic lung disease. Evidence suggests that quality of life improves following exercise training according to St George's Respiratory Questionnaire (SGRQ) total score (MD -9.62 points, 95% CI -15.67 to -3.56 points; 3 studies, 160 participants; low-certainty evidence), which exceeds the MCID of 4 points for this outcome. A reduction in dyspnoea (MD 1.0 points, 95% CI 0.47 to 1.53; 1 study, 76 participants) and fatigue (MD 1.51 points, 95% CI 0.80 to 2.22 points; 1 study, 76 participants) was observed following exercise training according to these domains of the Chronic Respiratory Disease Questionnaire. However, there was no change in cough-related quality of life as measured by the Leicester Cough Questionnaire (LCQ) (MD -0.09 points, 95% CI -0.98 to 0.80 points; 2 studies, 103 participants; moderate-certainty evidence), nor in anxiety or depression. Two studies reported longer-term outcomes up to 12 months after intervention completion; however exercise training did not appear to improve exercise capacity or quality of life more than usual care. Exercise training reduced the number of acute exacerbations of bronchiectasis over 12 months in people with stable bronchiectasis (odds ratio 0.26, 95% CI 0.08 to 0.81; 1 study, 55 participants). After an acute exacerbation of bronchiectasis, data from a single study (N = 27) suggest that exercise training compared to usual care confers little to no effect on exercise capacity (MD 11 metres, 95% CI -27 to 49 metres; low-certainty evidence), SGRQ total score (MD 6.34 points, 95%CI -17.08 to 29.76 points), or LCQ score (MD -0.08 points, 95% CI -0.94 to 0.78 points; low-certainty evidence) and does not reduce the time to first exacerbation (hazard ratio 0.83, 95% CI 0.31 to 2.22). Authors' conclusions: This review provides low-certainty evidence suggesting improvement in functional exercise capacity and quality of life immediately following exercise training in people with stable bronchiectasis; however the effects of exercise training on cough-related quality of life and psychological symptoms appear to be minimal. Due to inadequate reporting of methods, small study numbers, and variation between study findings, evidence is of very low to moderate certainty. Limited evidence is available to show longer-term effects of exercise training on these outcomes.

The Cochrane database of systematic reviews · meta-analysis · 29 citationsread the source →

Support for healthy breastfeeding mothers with healthy term babies.

Background: There is extensive evidence of important health risks for infants and mothers related to not breastfeeding. In 2003, the World Health Organization recommended that infants be breastfed exclusively until six months of age, with breastfeeding continuing as an important part of the infant's diet until at least two years of age. However, current breastfeeding rates in many countries do not reflect this recommendation. Objectives: 1. To describe types of breastfeeding support for healthy breastfeeding mothers with healthy term babies. 2. To examine the effectiveness of different types of breastfeeding support interventions in terms of whether they offered only breastfeeding support or breastfeeding support in combination with a wider maternal and child health intervention ('breastfeeding plus' support).  3. To examine the effectiveness of the following intervention characteristics on breastfeeding support:      a. type of support (e.g. face-to-face, telephone, digital technologies, group or individual support, proactive or reactive);      b. intensity of support (i.e. number of postnatal contacts);      c. person delivering the intervention (e.g. healthcare professional, lay person);     d. to examine whether the impact of support varied between high- and low-and middle-income countries. Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register (which includes results of searches of CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP)) (11 May 2021) and reference lists of retrieved studies. Selection criteria: Randomised or quasi-randomised controlled trials comparing extra support for healthy breastfeeding mothers of healthy term babies with usual maternity care. Support could be provided face-to-face, over the phone or via digital technologies. All studies had to meet the trustworthiness criteria.  DATA COLLECTION AND ANALYSIS: We used standard Cochrane Pregnancy and Childbirth methods. Two review authors independently selected trials, extracted data, and assessed risk of bias and study trustworthiness.  The certainty of the evidence was assessed using the GRADE approach. Main results: This updated review includes 116 trials of which 103 contribute data to the analyses. In total more than 98,816 mother-infant pairs were included.  Moderate-certainty evidence indicated that 'breastfeeding only' support probably reduced the number of women stopping breastfeeding for all primary outcomes: stopping any breastfeeding at six months (Risk Ratio (RR) 0.93, 95% Confidence Interval (CI) 0.89 to 0.97); stopping exclusive breastfeeding at six months (RR 0.90, 95% CI 0.88 to 0.93); stopping any breastfeeding at 4-6 weeks (RR 0.88, 95% CI 0.79 to 0.97); and stopping exclusive breastfeeding at 4-6 (RR 0.83 95% CI 0.76 to 0.90). Similar findings were reported for the secondary breastfeeding outcomes except for any breastfeeding at two months and 12 months when the evidence was uncertain if 'breastfeeding only' support helped reduce the number of women stopping breastfeeding.  The evidence for 'breastfeeding plus' was less consistent. For primary outcomes there was some evidence that 'breastfeeding plus' support probably reduced the number of women stopping any breastfeeding (RR 0.94, 95% CI 0.91 to 0.97, moderate-certainty evidence) or exclusive breastfeeding at six months (RR 0.79, 95% CI 0.70 to 0.90).  'Breastfeeding plus' interventions may have a beneficial effect on reducing the number of women stopping exclusive breastfeeding at 4-6 weeks, but the evidence is very uncertain (RR 0.73, 95% CI 0.57 to 0.95). The evidence suggests that 'breastfeeding plus' support probably results in little to no difference in the number of women stopping any breastfeeding at 4-6 weeks (RR 0.94, 95% CI 0.82 to 1.08, moderate-certainty evidence). For the secondary outcomes, it was uncertain if 'breastfeeding plus' support helped reduce the number of women stopping any or exclusive breastfeeding at any time points.  There were no consistent findings emerging from the narrative synthesis of the non-breastfeeding outcomes (maternal satisfaction with care, maternal satisfaction with feeding method, infant morbidity, and maternal mental health), except for a possible reduction of diarrhoea in intervention infants.  We considered the overall risk of bias of trials included in the review was mixed. Blinding of participants and personnel is not feasible in such interventions and as studies utilised self-report breastfeeding data, there is also a risk of bias in outcome assessment.   We conducted meta-regression to explore substantial heterogeneity for the primary outcomes using the following categories: person providing care; mode of delivery; intensity of support; and income status of country.  It is possible that moderate levels (defined as 4-8 visits) of 'breastfeeding only' support may be associated with a more beneficial effect on exclusive breastfeeding at 4-6 weeks and six months. 'Breastfeeding only' support may also be more effective in reducing women in low- and middle-income countries (LMICs) stopping exclusive breastfeeding at six months compared to women in high-income countries (HICs). However, no other differential effects were found and thus heterogeneity remains largely unexplained. The meta-regression suggested that there were no differential effects regarding person providing support or mode of delivery, however, power was limited.  AUTHORS' CONCLUSIONS: When 'breastfeeding only' support is offered to women, the duration and in particular, the exclusivity of breastfeeding is likely to be increased. Support may also be more effective in reducing the number of women stopping breastfeeding at three to four months compared to later time points.  For 'breastfeeding plus' interventions the evidence is less certain. Support may be offered either by professional or lay/peer supporters, or a combination of both. Support can also be offered face-to-face, via telephone or digital technologies, or a combination and may be more effective when delivered on a schedule of four to eight visits. Further work is needed to identify components of the effective interventions and to deliver interventions on a larger scale.

The Cochrane database of systematic reviews · systematic review · 92 citationsread the source →

Development of emotional and behavioral regulation in children born extremely preterm and very preterm: biological and social influences.

This study describes the development of emotional and behavioral regulation in a regional cohort of children born extremely preterm (<28 weeks gestational age, n = 39), very preterm (<34 weeks gestational age, n = 56), and full term (n = 103). At 2 and 4 years, children born at younger gestational ages demonstrated poorer self-regulation across multiple contexts spanning observed interactions, formal cognitive testing, and parental report of child behavior at home. Among children born preterm, the 2 strongest predictors of impairments in self-regulation were the presence of moderate-to-severe cerebral white matter abnormalities on neonatal magnetic resonance and a less sensitive parenting style when children were aged 2 years. Findings support the importance of early neurological development and parenting for developing regulation in children born very preterm.

Child development · 150 citationsread the source →

Comparative effectiveness of cognitive behavioural therapy, modafinil, and their combination for treating fatigue in multiple sclerosis (COMBO-MS): a randomised, statistician-blinded, parallel-arm trial.

Background: Fatigue is one of the most disabling symptoms reported by people with multiple sclerosis. Although behavioural and pharmacological interventions might be partly beneficial, their combined effects have not been evaluated for multiple sclerosis fatigue, or examined with sufficient consideration of characteristics that might affect treatment response. In this comparative effectiveness research trial, we compared the effectiveness of cognitive behavioural therapy (CBT), modafinil, and their combination for treating multiple sclerosis fatigue. Methods: This randomised, analyst-blinded, parallel-arm, comparative effectiveness trial was done at two universities in the USA. Adults (aged ≥18 years) with multiple sclerosis and problematic fatigue (Fatigue Severity Scale [FSS] score ≥4) were randomly assigned (1:1:1), using a web-based treatment assignment system with minimisation, to receive CBT, modafinil, or both for 12 weeks. Statisticians were masked to group assignment, but participants, study neurologists, CBT interventionalists, and coordinators were not masked to treatment assignment. The primary outcome was the change in Modified Fatigue Impact Scale (MFIS) from baseline to 12 weeks, assessed using multiple linear regression, adjusted for age, sex, study site, anxiety, pain, baselines MFIS score, and physical activity. Analyses were done by intent to treat. The trial was registered with clinicaltrials.gov, NCT03621761, and is completed. Findings: Between Nov 15, 2018, and June 2, 2021, 336 participants were randomly assigned treatment (114 assigned to CBT, 114 assigned to modafinil, and 108 assigned to combination therapy). At 12 weeks, CBT (n=103), modafinil (n=107), and combination therapy (n=102) were associated with clinically meaningful within-group MFIS reductions of 15·20 (SD 11·90), 16·90 (15·90), and 17·30 (16·20) points, respectively. Change in MFIS scores from baseline to 12 weeks did not differ between groups: relative to combination therapy, the adjusted total mean difference in MFIS change score was 1·88 (95% CI -2·21 to 5·96) for CBT and 1·20 (-2·83 to 5·23) for modafinil. Most common adverse events for modafinil-containing treatment groups included insomnia (eight [7%] for modafinil and eight [7%] for combination therapy) and anxiety (three [3%] for modafinil and nine [8%] for combination therapy). Interpretation: Modafinil, CBT, and combination therapy were associated with similar reductions in the effects of multiple sclerosis fatigue at 12 weeks. Combination therapy was not associated with augmented improvement compared with the individual interventions. Further research is needed to determine whether effects of these interventions on multiple sclerosis-related fatigue is influenced by sleep hygiene and sleepiness. No serious adverse events related to the study drug were encountered. Funding: Patient-Centered Outcomes Research Institute and National Multiple Sclerosis Society.

The Lancet. Neurology · randomised controlled trial · 6 citationsread the source →

Effects of a 4-week transitional care programme for discharged stroke survivors in Hong Kong: a randomised controlled trial.

Stroke rehabilitation involves care issues concerning the physical, psychosocial and spiritual aspects. Hospital-based rehabilitation has its limitations because many of the care issues only emerge when patients return home. Transitional care models supporting patients after discharge from the hospital have proved to be effective among chronically ill patients, but limited studies were conducted among stroke survivors. This study was a randomised controlled trial conducted to test the effectiveness of a transitional care programme (TCP) which was a nurse-led 4-week programme designed based on the assessment-intervention-evaluation Omaha System framework. Between August 2010 and October 2011, 108 stroke patients who were discharged home, able to communicate, and had slight to moderate neurological deficits and disability were randomised into control (n = 54) and intervention groups (n = 54). Data on the patient-related and clinical outcomes were collected at baseline, 4 weeks when the TCP was completed and 8 weeks after discharge from hospital. Repeated measures analysis of variance with intention-to-treat strategy was used to examine the outcomes. There were significant between-group differences in quality of life, the primary outcome measure of this study, in both physical (F(1, 104) = 10.15, P = 0.002) and mental (F(1, 104) = 8.41, P = 0.005) domains, but only the physical domain achieved a significant time × intervention interaction effect (F(1, 103) = 7.73, P = 0.006). The intervention group had better spiritual-religion-personal measures, higher satisfaction, higher Modified Barthel Index scores and lower depression scores when compared with the control group. They also had lower hospital readmission and use of emergency room rates, but only the use of emergency room had significant difference when compared to control. This study is original in testing a transitional model among stroke patients discharged from hospital. The TCP shares common features that have been proved to be effective when applied to chronically ill patients, and the duration of 4 weeks seems to be adequate to bring about immediate effects.

Health & social care in the community · randomised controlled trial · 66 citationsread the source →

A Randomized Stepped Care Intervention Trial Targeting Posttraumatic Stress Disorder for Surgically Hospitalized Injury Survivors

In Brief Objective: To test the effectiveness of a stepped care intervention model targeting posttraumatic stress disorder (PTSD) symptoms after injury. Background: Few investigations have evaluated interventions for injured patients with PTSD and related impairments that can be feasibly implemented in trauma surgical settings. Methods: The investigation was a pragmatic effectiveness trial in which 207 acutely injured hospitalized trauma survivors were screened for high PTSD symptom levels and then randomized to a stepped combined care management, psychopharmacology, and cognitive behavioral psychotherapy intervention (n = 104) or usual care control (n = 103) conditions. The symptoms of PTSD and functional limitations were reassessed at 1, 3, 6, 9, and 12 months after the index injury admission. Results: Regression analyses demonstrated that over the course of the year after injury, intervention patients had significantly reduced PTSD symptoms when compared with controls [group by time effect, CAPS (Clinician-Administered PTSD Scale): F(2, 185) = 5.50, P < 0.01; PCL-C (PTSD Checklist Civilian Version): F(4, 185) = 5.45, P < 0.001]. Clinically and statistically significant PTSD treatment effects were observed at the 6-, 9-, and 12-month postinjury assessments. Over the course of the year after injury, intervention patients also demonstrated significant improvements in physical function [MOS SF-36 PCS (Medical Outcomes Study Short Form 36 Physical Component Summary) main effect: F(1, 172) = 9.87, P < 0.01]. Conclusions: Stepped care interventions can reduce PTSD symptoms and improve functioning over the course of the year after surgical injury hospitalization. Orchestrated investigative and policy efforts could systematically introduce and evaluate screening and intervention procedures for PTSD at US trauma centers. (Trial Registration: clinicaltrials.gov identifier: NCT00270959) Acutely injured surgically hospitalized trauma survivors were screened for high posttraumatic stress disorder (PTSD) symptom levels and then randomized to a stepped-care intervention (n = 104) or a usual-care intervention (n = 103). Intervention patients demonstrated clinically and statistically significant reductions in PTSD symptoms and improved physical function over the course of the year after injury. Orchestrated investigative and policy efforts could systematically introduce and evaluate screening and intervention procedures for PTSD at US trauma centers.

Annals of Surgery · randomised controlled trial · 229 citationsread the source →

Cognitive Behavior Therapy Versus Other Psychosocial Treatments for Schizophrenia

Cognitive behavioral therapy (CBT) is now a recommended treatment for people with schizophrenia. In CBT, links are made between the person’s feelings and patterns of thinking that underpin their distress. At present, a variety of interventions have been labeled as CBT and it is difficult to provide a single, unambiguous definition. In recognition, the review authors have constructed criteria that are felt to be both workable and to capture the elements of good practice in CBT. Cognitive behavioral therapy is becoming increasingly available for people with schizophrenia, with recent recommendations of treatment guidelines in, for example, the United Kingdom suggesting that CBT should be more widely available for people with schizophrenia. It should be noted that many of the trials of CBT for psychosis have incorporated additional active therapeutic elements (eg, psychoeducation and relapse prevention) that would be considered adjunctive to techniques that are specifically targeted at eliciting belief change (eg, guided discovery or behavioral experiments). The comparison arm of the trials reported other psychosocial therapies, such as supportive therapy, psychoeducation, family therapy, and other “talking therapies.” The full review distinguishes between trials that described “active” psychosocial interventions (eg, family therapy) aimed at a meaningful symptom reduction and those trials that have used “nonactive” psychosocial interventions (eg, supportive therapy), which act as merely a control for the nonspecific effects of therapy (eg, time spent with therapist). Outcomes are presented separately for active and nonactive psychosocial interventions and the pooled effect of these trials is also presented. We searched the Cochrane Schizophrenia Group Trials Register (March 2010) that is based on regular searches of CINAHL, EMBASE, MEDLINE, and PsycINFO. We inspected all references of the selected articles for further relevant trials, and, where appropriate, contacted authors. All relevant randomized controlled trials of CBT for people with schizophrenia-like illnesses. Studies were reliably selected and assessed for methodological quality. Two review authors, working independently, extracted data. We analyzed dichotomous data on an intention-to-treat basis and continuous data with 65% completion rate are presented. Where possible, for dichotomous outcomes, we estimated a risk ratio (RR) with the 95% confidence interval (CI) along with the number needed to treat/harm. Thirty articles described 20 trials. Trials were often small and of limited quality. In figure 1 the various risks of bias are presented as percentages across all included studies. Risk of bias chart. The main findings of this review are summarized in table 1. When CBT was compared with other psychosocial therapies, no difference was found for outcomes relevant to adverse effect/events (2 RCTs, n = 202, RR death 0.57 CI 0.12–2.60). Relapse was not either reduced over any time period (5 RCTs, n = 183, RR long term 0.91 CI 0.63–1.32) nor was rehospitalization (5 RCTs, n = 294, RR in longer term 0.86 CI 0.62–1.21). Various global mental state measures failed to show difference (4 RCTs, n = 244, RR no important change in mental state 0.84 CI 0.64–1.09). More specific measures of mental state failed to show differential effects on positive or negative symptoms of schizophrenia, but there may be some long-term effect for affective symptoms (2 RCTs, n = 105, mean difference (MD) Beck Depression Inventory (BDI) −6.21 CI −10.81 to −1.61). Few trials report on social functioning or quality of life. Findings do not convincingly favor either of the interventions (2 RCTs, n = 103, MD Social Functioning Scale (SFS) 1.32 CI −4.90 to 7.54; n = 37, MD EuroQOL −1.86 CI −19.20 to 15.48). For the outcome of leaving the study early, we found no significant advantage when CBT was compared with either nonactive control therapies (4 RCTs, n = 433, RR 0.88 CI 0.63–1.23) or active therapies (6 RCTs, n = 339, RR 0.75 CI 0.40–1.43). Summary of Findings a The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 Medium risk: roughly equates with that of the trial control groups. 2Limitation in design—rated “serious”: studies short, randomization poorly described, blinding at outcome—single at best and untested. 3Imprecision—rated “serious”: one small study. 4Imprecision—rated “serious”: no other studies made any report of adverse effects. 5Publication bias: rated “likely”: all trials were small—searches may fail to identify other small less positive trials. 6Long term: defined as over 1 year. 7Indirectness—rated “serious”: various measures used with differing criteria. 8Indirectness—rated “serious”: scale derived data—not “employment” as stated in protocol. Summary of Findings a The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio. GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 Medium risk: roughly equates with that of the trial control groups. 2Limitation in design—rated “serious”: studies short, randomization poorly described, blinding at outcome—single at best and untested. 3Imprecision—rated “serious”: one small study. 4Imprecision—rated “serious”: no other studies made any report of adverse effects. 5Publication bias: rated “likely”: all trials were small—searches may fail to identify other small less positive trials. 6Long term: defined as over 1 year. 7Indirectness—rated “serious”: various measures used with differing criteria. 8Indirectness—rated “serious”: scale derived data—not “employment” as stated in protocol. The use of CBT has been associated with some reduction in symptoms, particularly affective problems associated with having such a serious illness. However, there is considerable variability in the findings of the various studies and, at present, it is not possible to assert any substantial benefit for cognitive behavioral therapy over other psychological therapies. Full details are published in the Cochrane Review (Jones, 2012).

Schizophrenia Bulletin · cohort or longitudinal · 173 citationsread the source →

Randomized controlled trial of once-per-week intermittent fasting for health improvement: the WONDERFUL trial.

Aims: Low-density lipoprotein cholesterol (LDL-C) predicts heart disease onset and may be reduced by intermittent fasting. Some studies, though, reported that fasting increased LDL-C; however, no study evaluated LDL-C as the primary endpoint. This randomized controlled trial evaluated the effect of low-frequency intermittent fasting on LDL-C and other biomarkers. Methods and results: Adults aged 21-70 years were enrolled who were not taking a statin, had modestly elevated LDL-C, had ≥1 metabolic syndrome feature or type 2 diabetes, and were not taking anti-diabetic medication (N = 103). Water-only 24-h fasting was performed twice weekly for 4 weeks and then once weekly for 22 weeks; controls ate ad libitum. The primary outcome was 26-week LDL-C change score. Secondary outcomes (requiring P ≤ 0.01) were 26-week changes in homeostatic model assessment of insulin resistance (HOMA-IR), Metabolic Syndrome Score (MSS), brain-derived neurotrophic factor (BDNF), and MicroCog general cognitive proficiency index (GCPi). Intermittent fasting (n = 50) and control (n = 53) subjects were, respectively, aged 49.3 ± 12.0 and 47.0 ± 9.8 years, predominantly female (66.0% and 67.9%), and overweight (103 ± 24 and 100 ± 21 kg) and had modest LDL-C elevation (124 ± 19 and 128 ± 20 mg/dL). Drop-outs (n = 12 fasting, n = 20 control) provided an evaluable sample of n = 71 (n = 38 fasting, n = 33 control). Intermittent fasting did not change LDL-C (0.2 ± 16.7 mg/dL) vs. control (2.5 ± 19.4 mg/dL; P = 0.59), but it improved HOMA-IR (-0.75 ± 0.79 vs. -0.10 ± 1.06; P = 0.004) and MSS (-0.34 ± 4.72 vs. 0.31 ± 1.98, P = 0.006). BDNF (P = 0.58), GCPi (P = 0.17), and weight (-1.7 ± 4.7 kg vs. 0.2 ± 3.5 kg, P = 0.06) were unchanged. Conclusions: A low-frequency intermittent fasting regimen did not reduce LDL-C or improve cognitive function but significantly reduced both HOMA-IR and MSS. Trial registration: clinicaltrials.gov, NCT02770313.

European heart journal open · 30 citationsread the source →

Shift work disorder among oil rig workers in the North Sea.

Study objectives: Shift work disorder (SWD) is a circadian rhythm sleep disorder caused by work hours during the usual sleep period. The main symptoms are excessive sleepiness and insomnia temporally associated with the working schedule. The aim of the present study was to examine SWD among shift workers in the North Sea. Design and participants: A total of 103 shift workers (2 weeks on 7 nights/7days, 12-h shifts, 4 weeks off), mean age 39.8 years, working at an oil rig in the North Sea responded to a questionnaire about SWD. They also completed the Pittsburgh Sleep Quality Index, Bergen Insomnia Scale, Epworth Sleepiness Scale, Composite Morningness Questionnaire, Subjective Health Complaint Inventory, Demand/Control, and Instrumental Mastery Oriented Coping (based on the Utrecht Coping list). Most of these instruments were administered during the first day of the 2-week working period, thus reflecting symptoms and complaints during the 4-week non-work period. The shift workers were also compared to day workers at the oil rig. Results: Twenty-four individuals were classified as suffering from SWD, yielding a prevalence for SWD of 23.3%. During the 4-week non-work period, individuals with SWD reported significantly poorer sleep quality, as measured by the Pittsburgh Sleep Quality Index, and more subjective health complaints than individuals not having SWD. There were no differences between the 2 groups in sleepiness, insomnia, circadian preference, psychological demands, or control. Individuals with SWD reported significantly lower scores on coping. The reports of shift workers without SWD were similar to those of day workers regarding sleep, sleepiness, subjective health complaints, and coping. Conclusions: The prevalence of SWD was relatively high among these shift workers. Individuals with SWD reported poorer sleep quality and more subjective health complaints in the non-work period than shift workers not having SWD.

Sleep · 92 citationsread the source →

Compassion for others, self-compassion, quality of life and mental well-being measures and their association with compassion fatigue and burnout in student midwives: A quantitative survey.

Background: compassion fatigue and burnout can impact on the performance of midwives, with this quantitative paper exploring the relationship between self-compassion, burnout, compassion fatigue, self-judgement, self-kindness, compassion for others, professional quality of life and well-being of student midwives. Method: a quantitative survey measured relationships using questionnaires: (1) Professional Quality of Life Scale; (2) Self-Compassion Scale; (3) Short Warwick and Edinburgh Mental Well-being Scale; (4) Compassion For Others Scale. Participants: a purposive and convenience sample of student midwives (n=103) studying at university participated in the study. Results: just over half of the sample reported above average scores for burnout. The results indicate that student midwives who report higher scores on the self-judgement sub-scale are less compassionate towards both themselves and others, have reduced well-being, and report greater burnout and compassion fatigue. Student midwives who report high on measures of self-compassion and well-being report less compassion fatigue and burnout. Conclusion: student midwives may find benefit from 'being kinder to self' in times of suffering, which could potentially help them to prepare for the emotional demands of practice and study. Implications: developing, creating and cultivating environments that foster compassionate care for self and others may play a significant role in helping midwives face the rigours of education and clinical practice during their degree programme.

Midwifery · 91 citationsread the source →

Implementation and evaluation of a harm-reduction model for clinical care of substance using pregnant women.

Background: Methamphetamine (MA) use during pregnancy is associated with many pregnancy complications, including preterm birth, small for gestational age, preeclampsia, and abruption. Hawaii has lead the nation in MA use for many years, yet prior to 2007, did not have a comprehensive plan to care for pregnant substance-using women. In 2006, the Hawaii State Legislature funded a pilot perinatal addiction clinic. The Perinatal Addiction Treatment Clinic of Hawaii was built on a harm-reduction model, encompassing perinatal care, transportation, child-care, social services, family planning, motivational incentives, and addiction medicine. We present the implementation model and results from our first one hundred three infants (103) seen over 3 years of operation of the program. Methods: Referrals came from community health centers, hospitals, addiction treatment facilities, private physician offices, homeless outreach services and self-referral through word-of-mouth and bus ads. Data to describe sample characteristics and outcome was obtained prospectively and retrospectively from chart abstraction and delivery data. Drug use data was obtained from the women's self-report and random urine toxicology during the pregnancy, as well as urine toxicology at the time of birth on mothers, and urine and meconium toxicology on the infants. Post-partum depression was measured in mothers with the Edinburgh Post-Partum depression scale. Data from Path clinic patients were compared with a representative cohort of women delivering at Kapiolani Medical Center for Women and Children during the same time frame, who were enrolled in another study of pregnancy outcomes. Ethical approval for this study was obtained through the University of Hawaii Committee for Human Studies. Results: Between April 2007 and August 2010, 213 women with a past or present history of addiction were seen, 132 were pregnant and 97 delivered during that time. 103 live-born infants were delivered. There were 3 first-trimester Spontaneous Abortions, two 28-week intrauterine fetal deaths, and two sets of twins and 4 repeat pregnancies. Over 50% of the women had lost custody of previous children due to substance use. The majority of women who delivered used methamphetamine (86%), either in the year before pregnancy or during pregnancy. Other drugs include marijuana (59.8%), cocaine (33%), opiates (9.6%), and alcohol (15.2%). Of the women served, 85% smoked cigarettes upon enrollment. Of the 97 women delivered during this period, all but 4 (96%) had negative urine toxicology at the time of delivery. Of the 103 infants, 13 (12.6%) were born preterm, equal to the state and national average, despite having many risk factors for prematurity, including poverty, poor diet, smoking and polysubstance use. Overwhelmingly, the women are parenting their children, > 90% retained custody at 8 weeks. Long-term follow-up showed that women who maintained custody chose long-acting contraceptive methods; while those who lost custody had a very high (> 50%) repeat pregnancy rate at 9 months post delivery. Conclusion: Methamphetamine use during pregnancy doesn't exist is isolation. It is often combined with a multitude of other adverse circumstances, including poverty, interpersonal violence, psychiatric comorbidity, polysubstance use, nutritional deficiencies, inadequate health care and stressful life experiences. A comprehensive harm reduction model of perinatal care, which aims to ameliorate some of these difficulties for substance-using women without mandating abstinence, provides exceptional birth outcomes and can be implemented with limited resources.

Harm reduction journal · 42 citationsread the source →

Do Children with Better Inhibitory Control Donate More? Differentiating between Early and Middle Childhood and Cool and Hot Inhibitory Control.

Inhibitory control may play an important part in prosocial behavior, such as donating behavior. However, it is not clear at what developmental stage inhibitory control becomes associated with donating behavior and which aspects of inhibitory control are related to donating behavior during development in early to middle childhood. The present study aimed to clarify these issues with two experiments. In Experiment 1, 103 3- to 5-year-old preschoolers completed cool (Stroop-like) and hot (delay of gratification) inhibitory control tasks and a donating task. The results indicated that there were no relationships between cool or hot inhibitory control and donating behavior in the whole group and each age group of the preschoolers. In Experiment 2, 140 elementary school children in Grades 2, 4, and 6 completed cool (Stroop-like) and hot (delay of gratification) inhibitory control tasks and a donating task. The results showed that inhibitory control was positively associated with donating behavior in the whole group. Cool and hot inhibitory control respectively predicted donating behavior in the second and sixth graders. Therefore, the present study reveals that donating behavior increasingly relies on specific inhibitory control, i.e., hot inhibitory control as children grow in middle childhood.

Frontiers in psychology · 12 citationsread the source →

Functional impairment in the remission phase of bipolar disorder.

Objectives: The purpose of this study was to evaluate functional impairment in a group of patients with bipolar disorder in remission and to determine the extent of relationships between overall functioning and current depressive, manic and panic spectrum symptoms. Method: A subset of the patient population at the Pittsburgh site of the Systematic Treatment Enhancement Program in Bipolar Disorder (STEP-BD) study was evaluated in this study. The subsample comprises 103 male and female subjects with bipolar I disorder (n = 70), bipolar II disorder (n = 24), schizoaffective disorder - bipolar type (n = 4), or bipolar disorder NOS (n = 5). Subjects were evaluated in a period of remission (at least 4 weeks with no more than two depressive or manic symptoms). Subjects were assessed for overall functional status using the Work and Social Adjustment Scale (WSAS) and for current bipolar and panic spectrum symptoms using the Mood Spectrum Self-Report questionnaire (MOODS-SR) and Panic-Agoraphobic Spectrum Self-Report questionnaire (PAS-SR). Results: The median WSAS total score in these remitted subjects was 14, indicating significant functional impairment. Regressing WSAS on current depressive, manic, and panic spectrum total scores, we observed a highly significant depressive spectrum effect (t = 4.9, df = 94, p < 0.0001), but non-significant panic and manic spectrum effects (t = 1.3, df = 94, p = 0.19 and t = -1.8, df = 94, p = 0.07, respectively). Conclusion: Bipolar disorder is associated with functional deficits even during periods of sustained and substantial remission. The degree of functional impairment is correlated with the degree of depressive spectrum symptoms.

Bipolar disorders · 136 citationsread the source →

A longitudinal study of emotional intelligence training for otolaryngology residents and faculty.

Importance: Emotions underlie and influence physician communications and relationships with patients and colleagues. Training programs to enhance emotional attunement, or emotional intelligence (EI), for physicians and assess training effects are scarce. Objective: To assess whether an EI training program for otolaryngology residents and faculty affects patient satisfaction. Design, setting, and participants: Prospective longitudinal, cohort study of physician residents and faculty in an EI training program at the Department of Otolaryngology, University of Kansas Medical Center, with annual training from 2005 to 2011. Interventions: Three levels of interventions included 4 years of repeated EI assessment, 7 years of highly interactive EI training with high-risk/high-stress simulations, and ongoing modeling and mentoring of EI skills by faculty. Main outcomes and measures: Four levels of outcome of the EI training were assessed with the following questions: Did participants enjoy the program? Could they apply the training to their practice? Did it change their behavior? Did it affect patient satisfaction? The Emotional Quotient Inventory (EQ-i) was administered to faculty and residents, and the Press Ganey Patient Satisfaction Survey was completed by patients. Results: Ninety-seven percent of participants (103 of 106) reported that they enjoyed the programs, and 98% (104 of 106) reported that they have or could have applied what they learned. Participants demonstrated improvement in mean EQ-i scores from 102.19 (baseline/pretraining) to 107.29 (posttraining and assessment 1 year later; change, 6.71; 95% CI, 3.44-9.98). This increase was sustained in successive years, and these results were supported with linear growth curve analysis. The total department mean EQ-i score in pretraining year 2005 was 104.29 ("average" range), with posttraining scores in the "high average" range (112.46 in 2006, 111.67 in 2007, and 113.15 in 2008). An increase in EQ-i scores and EI training corresponded with an increase in patient satisfaction scores. Percentile rank patient satisfaction scores before EI training ranged from 85% to 90%; after training, scores ranged from 92% to 99%. Conclusions and relevance: Emotional intelligence training positively influences patient satisfaction and may enhance medical education and health care outcome.

JAMA otolaryngology-- head & neck surgery · 60 citationsread the source →

Effective interactions: Communication and high levels of marital satisfaction

Of all the significant relationships in the lives of human-beings, the marital relationship remains one of the most central and important to their well-being. For this rapid review the authors accessed four online databases (PsycINFO, PsychARTICLES, JSTOR Journals, and ScienceDirect) to examine the evidence on aspects of communication which contribute to high levels of marital satisfaction and to synthesise these findings. The search yielded 103 unique articles, of which 15 were ultimately included. Principal results found the following activities to relate to high marital satisfaction: 1) communication activities such as engaging in small talk and providing verbal and non-verbal messages of affection; 2) “positive” exchanges which include any interactions perceived by both parties as constructive; 3) effective conflict management including the use of responses of recalibration and reaffirmation (R-R response), the use of we-pronouns, and the Listener-Speaker technique; 4) possessing and implementing effective communication skills such as using “I” instead of “you” messages; and 5) using “positive” communication skills such as clarification to elicit “positive” affect such as feeling understood. The evidence suggests that mental health professionals working with married couples should seek to promote quality dyadic communication as part of treatment interventions.

Journal of Psychology in Africa · 39 citationsread the source →