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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
Interventions
Behavioral: Accept Yourself!
Behavioral: Weight Watchers
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

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
Arm && Interventions
GroupInterventionDescription
Accept Yourself! InterventionAccept Yourself!Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group
Behavioral Weight LossWeight WatchersWeight Watchers groups
Primary Outcome Measures
NameTimeMethod
Change in self-reported depression symptomsAt 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)

Change in clinician assessed depression symptomsAt 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)

Secondary Outcome Measures
NameTimeMethod
Change in cardiovascular fitness as assessed by six-minute walk testAt post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Change in systolic and diastolic blood pressureAt 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 activityAt post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Change in fasting LipidsAt post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
Change in fasting blood glucoseAt 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 weightAt 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

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