Clinical trial NCT02501239: Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women
Official title: Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Obesity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Hitchcock Foundation
First posted: 2015-07-17
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in clinician assessed depression symptoms
timeFrame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
measure: Change in self-reported depression symptoms
timeFrame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
Secondary outcomes:
measure: Change in fasting Lipids
timeFrame: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
measure: Change in systolic and diastolic blood pressure
timeFrame: At post-treatment (immediately following the three-month intervention) and 12 month follow up
measure: Change in fasting blood glucose
timeFrame: At post-treatment (immediately following the three-month intervention) and 12 month follow up
measure: Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)
timeFrame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
measure: Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)
timeFrame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
measure: Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
measure: Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)
timeFrame: At post-treatment (immediately following the three-month intervention)
measure: Change in weight
timeFrame: At post-treatment (immediately following the three-month intervention) and 12 month follow up
measure: Change in self-reported physical activity
timeFrame: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
measure: Change in cardiovascular fitness as assessed by six-minute walk test
timeFrame: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Margit I Berman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berman MI, Park J, Kragenbrink ME, Hegel MT. Accept Yourself! A Pilot Randomized Controlled Trial of a Self-Acceptance-Based Treatment for Large-Bodied Women With Depression. Behav Ther. 2022 Sep;53(5):913-926. doi: 10.1016/j.beth.2022.03.002. Epub 2022 Mar 23.