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

Not Applicable

Completed

• Conditions: Depression; Obesity

• Registration Number: NCT02501239
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Study Start: 2015-08-12
• Primary Completion: 2017-05-07
• Study Completion: 2017-05-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in systolic and diastolic blood pressure	At post-treatment (immediately following the three-month intervention) and 12 month follow up
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 self-reported physical activity	At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Change in fasting Lipids	At post-treatment (immediately following the three-month intervention) and at 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.
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.
Change in weight	At post-treatment (immediately following the three-month intervention) and 12 month follow up	Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States