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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

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

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

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

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