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Trial record 43 of 1505 for:    depression AND (woman OR women OR female)

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

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ClinicalTrials.gov Identifier: NCT02501239
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
Hitchcock Foundation
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Depression Obesity Behavioral: Accept Yourself! Behavioral: Weight Watchers Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Accept Yourself! Intervention
Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group
Behavioral: Accept Yourself!
Other Name: HAES/ACT
Active Comparator: Behavioral Weight Loss
Weight Watchers groups
Behavioral: Weight Watchers



Primary Outcome Measures :
  1. Change in clinician assessed depression symptoms [ Time Frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments. ]
    As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)

  2. Change in self-reported depression symptoms [ Time Frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments. ]
    As assessed by Patient Health Questionnaire-9 (PHQ-9)


Secondary Outcome Measures :
  1. Change in fasting Lipids [ Time Frame: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up. ]
  2. Change in systolic and diastolic blood pressure [ Time Frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up ]
  3. Change in fasting blood glucose [ Time Frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up ]
  4. 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. ]
  5. 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. ]
  6. 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. ]
  7. 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) ]
  8. Change in weight [ Time Frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up ]
    Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).

  9. Change in self-reported physical activity [ Time Frame: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up. ]
  10. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501239


Contacts
Contact: Margit I Berman, Ph.D. 603-650-4724 Margit.I.Berman@dartmouth.edu
Contact: Mark T Hegel, Ph.D. 603-650-6188 Mark.T.Hegel@hitchcock.org

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Margit I Berman, Ph.D.    603-650-4724    Margit.I.Berman@dartmouth.edu   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Hitchcock Foundation
Investigators
Principal Investigator: Margit I Berman, Ph.D Dartmouth College

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02501239     History of Changes
Other Study ID Numbers: D15151
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Depression
Depressive Disorder
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Body Weight Changes