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

NCT ID: NCT02501239

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-12

Study Completion Date

2017-05-07

Brief Summary

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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

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Conditions

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Depression Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Accept Yourself! Intervention

Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group

Group Type EXPERIMENTAL

Accept Yourself!

Intervention Type BEHAVIORAL

Behavioral Weight Loss

Weight Watchers groups

Group Type ACTIVE_COMPARATOR

Weight Watchers

Intervention Type BEHAVIORAL

Interventions

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Accept Yourself!

Intervention Type BEHAVIORAL

Weight Watchers

Intervention Type BEHAVIORAL

Other Intervention Names

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HAES/ACT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hitchcock Foundation

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Margit I. Berman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margit I Berman, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35987548 (View on PubMed)

Other Identifiers

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D15151

Identifier Type: -

Identifier Source: org_study_id

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