NCT02501239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

August 12, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2017

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

July 14, 2015

Last Update Submit

April 24, 2018

Conditions

DepressionObesity

Outcome Measures

Primary Outcomes (2)

  • Change in clinician assessed depression symptoms

    As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)

    At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.

  • Change in self-reported depression symptoms

    As assessed by Patient Health Questionnaire-9 (PHQ-9)

    At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.

Secondary Outcomes (10)

  • Change in fasting Lipids

    At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.

  • Change in systolic and diastolic blood pressure

    At post-treatment (immediately following the three-month intervention) and 12 month follow up

  • 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.

  • +5 more secondary outcomes

Study Arms (2)

Accept Yourself! Intervention

EXPERIMENTAL

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

Behavioral: Accept Yourself!

Behavioral Weight Loss

ACTIVE COMPARATOR

Weight Watchers groups

Behavioral: Weight Watchers

Interventions

Accept Yourself!BEHAVIORAL
Also known as: HAES/ACT
Accept Yourself! Intervention
Weight WatchersBEHAVIORAL
Behavioral Weight Loss

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (1)

  • 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.

    PMID: 35987548DERIVED

MeSH Terms

Conditions

DepressionObesity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Margit I Berman, Ph.D

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 17, 2015

Study Start

August 12, 2015

Primary Completion

May 7, 2017

Study Completion

May 7, 2017

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(1)