Depression, Obesity
Conditions
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.
Interventions
BEHAVIORALAccept Yourself!
BEHAVIORALWeight Watchers
Sponsors
Hitchcock Foundation
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 fasting Lipids | 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). |
| 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. | — |
| 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 systolic and diastolic blood pressure | At post-treatment (immediately following the three-month intervention) and 12 month follow up | — |
Countries
United States
Outcome results
None listed