DepressionNCT02501239
Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women
A study testing Accept Yourself! and Weight Watchers in people with Depression and Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Obesity
- What is being tested?
- Accept Yourself! and Weight Watchers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2015to 7 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
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
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.
- Conditions
- Depression, Obesity
- Being tested
- Accept Yourself!, Weight Watchers
- Medical subject headings
- Depression, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accept Yourself!Behavioural
Also called HAES/ACT
Weight WatchersBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Accept Yourself! Intervention | Experimental | Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group Receives: Behavioral: Accept Yourself! |
| Behavioral Weight Loss | Active comparator | Weight Watchers groups Receives: Behavioral: Weight Watchers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinician assessed depression symptoms
As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)
Measured: 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)
Measured: 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
Measured: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
Change in systolic and diastolic blood pressure
Measured: At post-treatment (immediately following the three-month intervention) and 12 month follow up
Change in fasting blood glucose
Measured: 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)
Measured: 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)
Measured: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)
Measured: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)
Measured: At post-treatment (immediately following the three-month intervention)
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).
Measured: At post-treatment (immediately following the three-month intervention) and 12 month follow up
Change in self-reported physical activity
Measured: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Change in cardiovascular fitness as assessed by six-minute walk test
Measured: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study start12 Aug 2015
- Primary completion7 May 2017
- Study completion7 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hitchcock Foundation
- Responsible party
- Principal investigator, Margit I. Berman, Dartmouth-Hitchcock Medical Center
- Investigators
- Margit I Berman, Ph.D, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501239
- Sponsor's protocol ID
- D15151
- Status last verified
- Apr 2018
- First submitted
- 14 Jul 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35987548
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02501239
- Acronym / sponsor ID
- D15151
- Conditions
- Depression, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Hitchcock Foundation
- Study start
- 12 Aug 2015 (actual)
- Primary completion
- 7 May 2017 (actual)
- Study completion
- 7 May 2017 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accept Yourself! Intervention | Experimental | Behavioral: Accept Yourself!Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group |
| Behavioral Weight Loss | Active comparator | Behavioral: Weight WatchersWeight Watchers groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accept Yourself!Also: HAES/ACT | Behavioural | Accept Yourself! Intervention |
| Weight Watchers | Behavioural | Behavioral Weight Loss |
Primary outcome
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)
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)
10 secondary outcomes
Change in fasting Lipids
Time frame: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
Change in systolic and diastolic blood pressure
Time frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up
Change in fasting blood glucose
Time frame: 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)
Time frame: 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)
Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
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.
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)
Change in weight
Time frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up
Change in self-reported physical activity
Time frame: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Derived from this study: PubMed 35987548Berman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margit I Berman, Ph.D principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accept Yourself! and Weight Watchers in people with Depression and Obesity, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.