Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women
Primary Purpose
Depression, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accept Yourself!
Weight Watchers
Sponsored by
About this trial
This is an interventional treatment trial for Depression
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Accept Yourself! Intervention
Behavioral Weight Loss
Arm Description
Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group
Weight Watchers groups
Outcomes
Primary Outcome Measures
Change in clinician assessed depression symptoms
As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)
Change in self-reported depression symptoms
As assessed by Patient Health Questionnaire-9 (PHQ-9)
Secondary Outcome Measures
Change in fasting Lipids
Change in systolic and diastolic blood pressure
Change in fasting blood glucose
Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)
Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)
Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)
Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)
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).
Change in self-reported physical activity
Change in cardiovascular fitness as assessed by six-minute walk test
Full Information
NCT ID
NCT02501239
First Posted
July 14, 2015
Last Updated
April 24, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Hitchcock Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02501239
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 12, 2015 (Actual)
Primary Completion Date
May 7, 2017 (Actual)
Study Completion Date
May 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Hitchcock Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Accept Yourself! Intervention
Arm Type
Experimental
Arm Description
Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group
Arm Title
Behavioral Weight Loss
Arm Type
Active Comparator
Arm Description
Weight Watchers groups
Intervention Type
Behavioral
Intervention Name(s)
Accept Yourself!
Other Intervention Name(s)
HAES/ACT
Intervention Type
Behavioral
Intervention Name(s)
Weight Watchers
Primary Outcome Measure Information:
Title
Change in clinician assessed depression symptoms
Description
As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)
Time Frame
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
Title
Change in self-reported depression symptoms
Description
As assessed by Patient Health Questionnaire-9 (PHQ-9)
Time Frame
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
Secondary Outcome Measure Information:
Title
Change in fasting Lipids
Time Frame
At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
Title
Change in systolic and diastolic blood pressure
Time Frame
At post-treatment (immediately following the three-month intervention) and 12 month follow up
Title
Change in fasting blood glucose
Time Frame
At post-treatment (immediately following the three-month intervention) and 12 month follow up
Title
Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)
Time Frame
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
Title
Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)
Time Frame
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
Title
Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)
Time Frame
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
Title
Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)
Time Frame
At post-treatment (immediately following the three-month intervention)
Title
Change in weight
Description
Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).
Time Frame
At post-treatment (immediately following the three-month intervention) and 12 month follow up
Title
Change in self-reported physical activity
Time Frame
At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Title
Change in cardiovascular fitness as assessed by six-minute walk test
Time Frame
At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margit I Berman, Ph.D
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35987548
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.
Results Reference
derived
Learn more about this trial
Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women
We'll reach out to this number within 24 hrs