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Effect of Integrated Behavioral Weight Loss Treatment and Problem-Solving Therapy on Body Mass Index and Depressive Symptoms Among Patients With Obesity and Depression: The RAINBOW Randomized Clinical Trial.

ABSTRACT: Importance:Coexisting obesity and depression exacerbate morbidity and disability, but effective treatments remain elusive. Objective:To test the hypothesis that an integrated collaborative care intervention would significantly improve both obesity and depression at 12 months compared with usual care. Design, Setting, and Participants:The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized clinical trial enrolled 409 adults with body mass indices (BMIs) of 30 or greater (?27 for Asian adults) and 9-item Patient Health Questionnaire (PHQ-9) scores of 10 or greater. Primary care patients at a health system in Northern California were recruited from September 30, 2014, to January 12, 2017; the date of final 12-month follow-up was January 17, 2018. Interventions:All participants randomly assigned to the intervention (n?=?204) or the usual care control group (n?=?205) received medical care from their personal physicians as usual, received information on routine services for obesity and depression at their clinic, and received wireless physical activity trackers. Intervention participants also received a 12-month intervention that integrated a Diabetes Prevention Program-based behavioral weight loss treatment with problem-solving therapy for depression and, if indicated, antidepressant medications. Main Outcomes and Measures:The co-primary outcome measures were BMI and 20-item Depression Symptom Checklist (SCL-20) scores (range, 0 [best] to 4 [worst]) at 12 months. Results:Among 409 participants randomized (mean age of 51.0 years [SD, 12.1 years]; 70% were women; mean BMI of 36.7 [SD, 6.4]; mean PHQ-9 score of 13.8 [SD, 3.1]; and mean SCL-20 score of 1.5 [SD, 0.5]), 344 (84.1%) completed 12-month follow-up. At 12 months, mean BMI declined from 36.7 (SD, 6.9) to 35.9 (SD, 7.1) among intervention participants compared with a change in mean BMI from 36.6 (SD, 5.8) to 36.6 (SD, 6.0) among usual care participants (between-group mean difference, -0.7 [95% CI, -1.1 to -0.2]; P?=?.01). Mean SCL-20 score declined from 1.5 (SD, 0.5) to 1.1 (SD, 1.0) at 12 months among intervention participants compared with a change in mean SCL-20 score from 1.5 (SD, 0.6) to 1.4 (SD, 1.3) among usual care participants (between-group mean difference, -0.2 [95% CI, -0.4 to 0]; P?=?.01). There were 47 adverse events or serious adverse events that involved musculoskeletal injuries (27 in the intervention group and 20 in the usual care group). Conclusions and Relevance:Among adults with obesity and depression, a collaborative care intervention integrating behavioral weight loss treatment, problem-solving therapy, and as-needed antidepressant medications significantly improved weight loss and depressive symptoms at 12 months compared with usual care; however, the effect sizes were modest and of uncertain clinical importance. Trial Registration:ClinicalTrials.gov Identifier: NCT02246413.

SUBMITTER: Ma J

PROVIDER: S-EPMC6439596 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Project description:Depressive symptoms and binge eating are both prevalent in weight management populations and may be associated with reduced benefit from behavioral weight loss, including higher attrition, more perceived barriers, lower weight loss, and increased weight regain. These two potential risk factors for poor behavioral weight loss outcomes may also be associated with each other as depressive symptoms may trigger binge eating, and binge eating-related distress could increase depressive symptoms. The depressive symptom-binge eating link has not been well studied in weight management samples, and psychological processes involved in this relationship have not yet been elucidated. Psychological flexibility, an individual's ability to be connected with and conscious of the present moment and to engage in values-consistent behavior even in the presence of difficult internal experiences, may be one psychological process that changes the depressive symptom-binge eating relationship. High psychological flexibility may be a protective factor in the association of depressive symptoms with binge eating. This study examined the relationship between depressive symptom and binge eating and a potential interactive role of psychological flexibility. Participants (N = 468, 76% female) completed self-report questionnaires of binge eating, depressive symptoms, and psychological flexibility at baseline prior to initiating behavioral weight loss. Depressive symptoms were positively associated with binge eating (B = 1.00, p < 0.001). Psychological flexibility had an interactive role (B = -0.03, p = 0.005). Among participants with minimal to mild depressive symptoms, those with higher psychological flexibility had less severe binge eating. Findings suggest that psychological flexibility may be a protective factor in the association between depressive symptoms and binge eating in the majority of individuals initiating behavioral weight loss. Psychological flexibility is a psychological process to consider targeting for enhancing efficacy of weight loss treatment, especially among individuals with minimal to mild depressive symptoms and binge eating behavior.

Project description:BackgroundDespite a high prevalence of antenatal depression in low- and middle-income countries, there is very little evidence for contextually adapted psychological interventions delivered in rural African settings. The aims of this study are (1) to examine the feasibility of procedures for a future fully powered efficacy trial of contextually adapted brief problem solving therapy (PST) for antenatal depression in rural Ethiopia, and (2) to investigate the acceptability, fidelity and feasibility of delivery of PST in routine antenatal care.MethodsDesign: A randomised, controlled, feasibility trial and mixed method process evaluation.ParticipantsConsecutive women attending antenatal clinics in two primary care facilities in rural Ethiopian districts. Eligibility criteria: (1) disabling levels of depressive symptoms (Patient Health Questionnaire (PHQ-9) score of five or more and positive for the 10th disability item); (2) gestational age 12-34 weeks; (3) aged 16 years and above; (4) planning to live in the study area for at least 6 months; (5) no severe medical or psychiatric conditions.InterventionFour sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks.Controlenhanced usual care (EUC).Sample sizen = 50. Randomisation: individual randomisation stratified by intimate partner violence (IPV). Allocation: central phone allocation. Outcome assessors and statistician masked to allocation status. Primary feasibility trial outcome: dropout rate. Primary future efficacy trial outcome: change in PHQ-9 score, assessed 9 weeks after recruitment.Secondary outcomesanxiety symptoms, trauma symptoms, intimate partner violence, disability, healthcare costs at 9 weeks; postnatal outcomes (perinatal and neonatal complications, onset of breast feeding, child health) assessed 4-6 weeks postnatal. Other trial feasibility indicators: recruitment, number and duration of sessions attended. Audio-recording of randomly selected sessions and in-depth interviews with purposively selected participants, healthcare providers and supervisors will be analysed thematically to explore the acceptability and feasibility of the trial procedures and fidelity of the delivery of PST.DiscussionThe findings of the study will be used to inform the design of a fully powered efficacy trial of brief PST for antenatal depression in routine care in rural Ethiopia.Trial registrationThe protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578 .

Project description:Evidence for the feasibility of brief psychological interventions for pregnant women experiencing intimate partner violence (IPV) in rural, low-income country settings is scarce. In rural Ethiopia, the prevalence of antenatal depressive symptoms and lifetime IPV are 29% and 61%, respectively. We aimed to assess the feasibility and related implementation outcomes of brief problem-solving therapy (PST) adapted for pregnant women experiencing IPV (PST-IPV) in rural Ethiopia, and of a randomised, controlled feasibility study design. We recruited 52 pregnant women experiencing depressive symptoms and past-year IPV from two antenatal care (ANC) services. Consenting women were randomised to PST-IPV (n = 25), 'standard' PST (not adapted for women experiencing IPV; n = 12) or enhanced usual care (information about sources of support; n = 15). Masked data collectors conducted outcome assessments nine weeks post-enrolment. Addis Ababa University (#032/19/CDT) and King's College London (#HR-18/19-9230) approved the study. Fidelity to randomisation was impeded by strong cultural norms about what constituted IPV. However, recruitment was feasible (recruitment rate: 1.5 per day; 37% of women screened were eligible). The intervention and trial were acceptable to women (4% declined initial screening, none declined to participate, and 76% attended all four sessions of either active intervention). PST-IPV was acceptable to ANC providers: none dropped out. Sessions lasting up to a mean 52 minutes raised questions about the appropriateness of the model to this context. Competence assessments recommended supplementary communication skills training. Fidelity assessments indicated high adherence, quality, and responsiveness but assessing risks and social networks, and discussing confidentiality needed improvement. Adjustments to optimise a future, fully powered, randomised controlled trial include staggering recruitment in line with therapist availability, more training on the types of IPV and how to discuss them, automating randomisation, a supervision cascade model, and conducting post-intervention outcome assessments immediately and three months postpartum. Registration: Pan African Clinical Trials Registry #PACTR202002513482084 (13/12/2019): https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9601.

Project description:IntroductionMany adults with overweight or obesity experience subclinical symptoms of depression, but little is known about how such symptoms are associated with physical activity (PA) or the experience of PA during behavioral weight loss (BWL) treatment.MethodsIn the current study, adults recruited from the community (N = 320) received 18 months of group-based BWL treatment and wore accelerometers at months 0, 6, and 18 to objectively measure PA. Participants with a mood disorder that was not well controlled were not eligible for the study and were referred for individual treatment. Depressive symptoms, PA barriers, discomfort avoidance, and self-control were self-reported with validated measures.ResultsAt baseline, the majority of participants indicated some depressive symptoms, mostly at subclinical levels. Results of multilevel models suggest that depressive symptoms were not significantly associated with concurrent measures of PA engagement (minutes/week) or sedentary behavior (minutes/week) at a given time point (i.e., baseline, 6 months, or 18 months). Results of cross-level interactions suggest that baseline depressive symptoms did not moderate the change in PA or sedentary behavior across time. Concurrent depressive symptoms and PA barriers were significantly and positively associated at a given time point (i.e., baseline, 6 months, or 18 months); however, baseline depressive symptoms did not moderate the improvement in perceived PA barriers across time. At baseline, higher discomfort avoidance and lower self-control each independently and partially mediated the relationship between depressive symptoms and PA barriers.ConclusionResults suggest that, among BWL samples in which most participants do not have clinically significant depressive symptoms, the likelihood of adopting and sustaining PA does not depend on the extent of depressive symptoms, but those with elevated symptoms may benefit from approaches that address their perception that engaging in PA is especially challenging.

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Effect of Integrated Behavioral Weight Loss Treatment and Problem-Solving Therapy on Body Mass Index and Depressive Symptoms Among Patients With Obesity and Depression: The RAINBOW Randomized Clinical Trial.

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