Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women

Study Overview
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Brief Summary
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The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself! compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments. Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.

Official Title
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Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women: A Randomized Controlled Trial

Conditions
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Obesity, Depression

Intervention / Treatment
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* Behavioral: Accept Yourself!
* Behavioral: Weight Watchers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV) Body Mass Index (BMI) greater than or equal to 30 Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study) Exclusion Criteria: current substance dependence history of psychotic symptoms high risk of suicide/self-harm current enrollment in a weight-loss program weight loss surgery in the past year current psychotherapy inability to postpone weight loss or depression treatment interventions for the duration of the study taking antipsychotic, tricyclic, or oral corticosteroid medication unwilling to be randomized to the study treatments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accept Yourself! Intervention<br>Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group | Behavioral: Accept Yourself!<br> <br> * Other names: HAES/ACT;|
| Active Comparator: Behavioral Weight Loss<br>Weight Watchers groups | Behavioral: Weight Watchers<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinician assessed depression symptoms | As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D) | At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments. | 
| Change in self-reported depression symptoms | As assessed by Patient Health Questionnaire-9 (PHQ-9) | At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting Lipids |  | At post-treatment (immediately following the three-month intervention) and at 12 month follow-up. | 
| Change in systolic and diastolic blood pressure |  | At post-treatment (immediately following the three-month intervention) and 12 month follow up | 
| Change in fasting blood glucose |  | At post-treatment (immediately following the three-month intervention) and 12 month follow up | 
| Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS) |  | At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments. | 
| Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97) |  | At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments. | 
| Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ) |  | At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments. | 
| Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits) |  | At post-treatment (immediately following the three-month intervention) | 
| Change in weight | Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group). | At post-treatment (immediately following the three-month intervention) and 12 month follow up | 
| Change in self-reported physical activity |  | At post-treatment (immediately following the three-month intervention) and at 12-month follow-up. | 
| Change in cardiovascular fitness as assessed by six-minute walk test |  | At post-treatment (immediately following the three-month intervention) and at 12-month follow-up. |