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Does an integrated collaborative care intervention improve weight loss and depressive symptoms among patients with obesity and depression?
In this randomized clinical trial that included 409 patients with obesity and depression, an intervention that integrated behavioral weight loss treatment and problem-solving therapy with as-needed antidepressant medications resulted in statistically significant reductions in body mass index compared with usual care (−0.7 vs −0.1, respectively) and depressive symptoms (−0.3 vs −0.1 on the 20-item Depression Symptom Checklist; score range, 0-4) at 12 months.
A collaborative care intervention integrating behavioral weight loss treatment and problem-solving therapy with as-needed antidepressant medication led to statistically significant reductions in body mass index and depressive symptoms compared with usual care; however, the effect sizes were modest and of uncertain clinical importance.
Coexisting obesity and depression exacerbate morbidity and disability, but effective treatments remain elusive.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02246413
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Corresponding Author: Jun Ma, MD, PhD, Institute of Health Research and Policy, University of Illinois, 1747 W Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608 (firstname.lastname@example.org).
Accepted for Publication: February 1, 2019.
Author Contributions: Dr Ma had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Ma, Lewis, Lavori.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Ma, Rosas, Lv, Xiao, Lewis.
Critical revision of the manuscript for important intellectual content: Ma, Rosas, Xiao, Snowden, Venditti, Lewis, Goldhaber-Fiebert, Lavori.
Statistical analysis: Xiao, Lavori.
Obtained funding: Ma, Lewis.
Administrative, technical, or material support: Rosas, Lv, Snowden, Venditti, Lewis.
Supervision: Ma, Rosas, Venditti.
Conflict of Interest Disclosures: Dr Lavori reported receiving personal fees from Palo Alto Medical Foundation Research Institute. No other disclosures were reported.
Funding/Support: This research was supported by award R01HL119453 from the National Heart, Lung, and Blood Institute and internal funding from the Palo Alto Medical Foundation Research Institute and the University of Illinois, Chicago.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Data Sharing Statement: See Supplement 5.
Additional Contributions: We thank Wayne Katon, MD (deceased), who contributed significantly to the conception and design of the study. We also thank the following paid research team members who contributed to the conduct of the study: Elizabeth Jameiro, MD, Nancy Wittels, MS, Veronica Luna, BS, Andrea Blonstein, MBA, RD, Kristen M. J. Azar, MSN/MPH (all from Sutter Health); Hoang Nguyen (Blue Shield of California); Lenard I. Lesser, MD, MSHS (One Medical); and Elizabeth Ward, MD (Pacific Coast Psychiatric Associates). We also thank the data and safety monitoring board members who received compensation for their time: William L. Haskell, PhD (chair), Manisha Desai, PhD, Sandra Tsai, MD, Mickey Trockel, MD, Manpreet Singh, MD, MS (all from Stanford University), and Alex Leow, MD, PhD (University of Illinois, Chicago). The data and safety monitoring board reviewed the study protocol initially and data quality and safety monitoring reports semiannually thereafter. We extend special thanks to the participants and their families who made this study possible.
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