RANDOMIZED CONTROLLED TRIAL OF BEHAVIORAL TREATMENT FOR CO-MORBID OBESITY AND DEPRESSION: THE BE ACTIVE TRIAL

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1 RANDOMIZED CONTROLLED TRIAL OF BEHAVIORAL TREATMENT FOR CO-MORBID OBESITY AND DEPRESSION: THE BE ACTIVE TRIAL Sherry Pagoto, PhD Associate Professor of Medicine Division of Preventive and Behavioral Medicine University of Massachusetts Medical School

2 Acknowledgements NIMH R01MH Kristin Schneider, PhD UMass Medical School Brad Appelhans, PhD Rush University Matt Whited, PhD UMass Medical School Molly E. Waring, PhD UMass Medical School Andrew M. Busch, Brown University and The Miriam Hospital Yunsheng Ma, PhD UMass Medical School Barbara Olendzki, RD, MPH UMass Medical School Stephenie Lemon, PhD UMass Medical School Ira Ockene, MD UMass Medical School Sybil Crawford, PhD UMass Medical School

3 Depression and Obesity Up to 37% of women presenting for weight loss treatment are clinically depressed (Pagoto et al 2007) Depression is associated with worse weight loss outcomes (Pagoto et al 2007, Clark et al 1996)

4 Depression and Obesity Research to practice gap clinical trial samples don t look like clinic patients (e.g., mean BDI in Look Ahead was 5.5, general population is ~6.75 and obese people with diabetes is about ~11) Next step is research in people who are more like our clinical patients.

5 The RCT literature: N=1 trial A randomized trial of simultaneous CBT for depression and a behavioral weight loss intervention versus behavioral weight loss intervention alone in 203 women with elevated depression symptoms No differences in weight or depression scores at 6- or 12-months Weight losses still lower than in trials of nondepressed ( kg vs 6.5 kg DPP) Linde et al 2011 Annals of Behavioral Medicine

6 The Be Active! Study A randomized clinical trial of 154 women with major depressive disorder and obesity R01 MH PI: S. Pagoto

7 Our Research Questions Since depression seems to interfere with the ability to lose weight, can we improve weight loss outcomes by treating depression first? Does improving depression associated with greater weight loss?

8 Conditions BA Behavioral Activation Behavioral Weight Loss Treatment ST Behavioral Weight Loss Treatment Time (Months) = Health Education Session

9 Behavioral Activation Shorter than full CBT Efficacy data reveal equivalent efficacy to CBT (Jacobsen et al 1996) and SSRI (Dimidijian et al 2006) NICE guidelines recommend BA as a first line treatment for depression (NICE, 2009) Manual is published (Lejuez, Hopko, Acierno, Daughters & Pagoto, 2011) (I can send to you)

10 Diabetes Prevention Program Lifestyle Intervention 16 visit core during first 6 months 6 monthly visits in second 6 months Delivered by a dietitian and exercise physiologist Weight loss goal = 7%, i.e., 1-2 pounds per week Exercise goal = 150 minutes per week

11 Sample Characteristics N = 154 women recruited from primary care and the community Mean age = 45.9 (sd = 10.83) Mean body mass index = (sd= 3.29) 71% Caucasian All met DSM-IV criteria for major depressive disorder via SCID-IV Mean BDI-II = (sd= 5.79, range 12-38)

12 Outcome measures Primary Outcomes Depression symptoms (BDI-II) Weight (% loss of total baseline body weight) Secondary Outcomes Blood pressure Lipids Dietary intake (daily calories) Physical activity (weekly minutes of moderate intensity activity)

13 Depression Outcomes (BDI-II) * * *p <.05 Note: Raw values, analyses adjusted for antidepressant use

14 Remission Rates (BDI-II) 61.2%*

15 Percent Weight Change 6-months Not significant No group differences in attendance

16 Percent Weight Change 12-months Not significant

17 Is depression not as tied to weight loss as we thought?

18 Differences in Weight Loss by Clinically Significant Improvement in Depression

19 What predicts clinically significant improvement in depression? Baseline physical activity (p <.05) ADHD symptoms (negative) (p<.05) BA condition (p<.05)

20 Be Active (BA) versus DPP

21 Dietary intake (calories/day)

22 Physical Activity (mins/week) program goal

23 Biological measures BA Condition (N = 78) ST Condition (N = 83) p-value Systolic BP (mmhg) 6 mos 12 mos Diastolic BP 6 mos 12 mos Total Cholesterol 6 mos 12 mos HDL (%) 6 mos 12 mos LDL (%) 6 mos 12 mos Total/HDL ratio (%) 6 mos 12 mos -3.1 (1.3) -0.7 (1.2) -2.8 (0.8) -0.3 (0.8) (1.40) (1.53) 2.84 (1.60) 6.80 (1.70) (1.98) 0.49 (2.68) (2.39) (2.11) -2.5 (1.2) -1.9 (1.2) -2.9 (0.8) -2.1 (0.8) (1.34) (1.49) 2.50 (1.53) (1.65) (1.9) (2.61) (2.3) (2.07)

24 Discussion Points 10-sessions of BA lead to greater improvement in depression and remission rates up to 1 year BA administered before a weight loss intervention does not hinder weight loss outcomes even though participants spent less time on weight loss BA Behavioral Activation Behavioral Weight Loss Treatment ST Behavioral Weight Loss Treatment Time (Months)

25 Clinical Implications 10 weeks of BA will significantly improve depression prior to a weight loss attempt Longer than 10 weeks may be needed for cases that aren t improving Continuous monitoring of depression is important Interventions for this population need more intensive exercise intervention (very sedentary)

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