Eating DisordersNCT00071578
Comparing Two Group Therapy Treatments for Binge Eating Disorder
A study testing Group Psychotherapy-Negative Emotion Focus and Group Psychotherapy- Self-Esteem Focus in people with Eating Disorders, run by Stanford University at 1 site in United States.
Trial summary
This study will compare two different approaches for the treatment for Binge Eating Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Group Psychotherapy-Negative Emotion Focus and Group Psychotherapy- Self-Esteem Focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jul 2007
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Binge Eating Disorder
- Reside in the San Francisco Bay Area
- Willing to commit to the study requirements
Who cannot join
- Unstable medical problems
- History of bipolar illness or schizophrenia
- Receiving treatment for an eating disorder (or unwillingness to discontinue treatment upon study entry)
- Membership in weight-loss groups such as Weight Watchers or Jenny Craig (or unwillingness to discontinue membership upon study entry)
- Use of medications affecting weight or appetite. Antidepressants are acceptable, but doses of any psychiatric medication must have been stable for at least 3 months prior to study start
- Breast-feeding
- Require gastric-bypass surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305-5722
About this study
Official title: Comparison of Dialectical Behavior Therapy and Supportive Therapy for Binge Eating Disorder
This study will compare two different approaches for the treatment for Binge Eating Disorder.
Read the detailed description
Binge Eating Disorder (BED) is associated with impairments in physical, psychological, and social functioning. Research has revealed relationships between disordered eating and both low self-esteem and negative emotional states.
Participants in this study will complete assessment interviews regarding their eating disorder and associated problems. Similar assessments will be conducted at the end of the study. Participants will then be randomly assigned to one of two therapy groups. Participants in one group will focus on the role of self-esteem, self-awareness, and personal effectiveness in binge eating. Participants in the other group will focus on the role of negative emotions and binge eating. Both treatments will involve a 30 to 40 minute pre-treatment individual orientation session, followed by 20 weeks of weekly group therapy. Sessions will take place over 22 weeks, or approximately 6 months (18 weekly sessions followed by 2 biweekly sessions). Follow-up assessments will take place at 3 months, 6 months, and 12 months after study completion to assess maintenance of treatment effects.
- Conditions
- Eating Disorders
- Being tested
- Group Psychotherapy-Negative Emotion Focus, Group Psychotherapy- Self-Esteem Focus
- Keywords
- Psychotherapy, Treatment
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Psychotherapy-Negative Emotion FocusBehavioural
20 weekly sessions, 2 hours, group format
Group Psychotherapy- Self-Esteem FocusBehavioural
20 weekly sessions, 2 hours, group format
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group therapy Negative Emotion Focus Receives: Behavioral: Group Psychotherapy-Negative Emotion Focus |
| 2 | Placebo comparator | Group Psychotherapy- Self Esteem Focus Receives: Behavioral: Group Psychotherapy- Self-Esteem Focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of binge eating
Measured: prior 4 weeks
Secondary outcomes (1)
Emotional Eating Scale
Measured: prior 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2003 (estimated)
- Study startOct 2003
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Debra L. Safer, Stanford University
- Investigators
- Debra L Safer, MD, Principal investigator, Stanford University Dept of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071578
- Sponsor's protocol ID
- K23MH066330
- Other IDs
- K23MH066330, DSIR 8K-RTAT
- Status last verified
- Jun 2013
- First submitted
- 29 Oct 2003
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dialectical Behavior Therapy and Supportive Therapy for Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT00071578
- Acronym / sponsor ID
- K23MH066330
- Conditions
- Eating Disorders
- Keywords
- Psychotherapy, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 30 Oct 2003 (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.
This study will compare two different approaches for the treatment for Binge Eating Disorder.
Detailed description
Binge Eating Disorder (BED) is associated with impairments in physical, psychological, and social functioning. Research has revealed relationships between disordered eating and both low self-esteem and negative emotional states.
Participants in this study will complete assessment interviews regarding their eating disorder and associated problems. Similar assessments will be conducted at the end of the study. Participants will then be randomly assigned to one of two therapy groups. Participants in one group will focus on the role of self-esteem, self-awareness, and personal effectiveness in binge eating. Participants in the other group will focus on the role of negative emotions and binge eating. Both treatments will involve a 30 to 40 minute pre-treatment individual orientation session, followed by 20 weeks of weekly group therapy. Sessions will take place over 22 weeks, or approximately 6 months (18 weekly sessions followed by 2 biweekly sessions). Follow-up assessments will take place at 3 months, 6 months, and 12 months after study completion to assess maintenance of treatment effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Group Psychotherapy-Negative Emotion FocusGroup therapy Negative Emotion Focus |
| 2 | Placebo comparator | Behavioral: Group Psychotherapy- Self-Esteem FocusGroup Psychotherapy- Self Esteem Focus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Binge Eating Disorder
- Reside in the San Francisco Bay Area
- Willing to commit to the study requirements
Key exclusion criteria (7 listed)
- Unstable medical problems
- History of bipolar illness or schizophrenia
- Receiving treatment for an eating disorder (or unwillingness to discontinue treatment upon study entry)
- Membership in weight-loss groups such as Weight Watchers or Jenny Craig (or unwillingness to discontinue membership upon study entry)
- Use of medications affecting weight or appetite. Antidepressants are acceptable, but doses of any psychiatric medication must have been stable for at least 3 months prior to study start
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 |
|---|---|---|
| Group Psychotherapy-Negative Emotion Focus20 weekly sessions, 2 hours, group format | Behavioural | 1 |
| Group Psychotherapy- Self-Esteem Focus20 weekly sessions, 2 hours, group format | Behavioural | 2 |
Primary outcome
frequency of binge eating
Time frame: prior 4 weeks
1 secondary outcome
Emotional Eating Scale
Time frame: prior 7 days
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 27 Jun 2013.
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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.
Debra L Safer, MD principal investigator
Stanford University Dept of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Psychotherapy-Negative Emotion Focus and Group Psychotherapy- Self-Esteem Focus in people with Eating Disorders, run by Stanford University 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 3 inclusion and 7 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 27 Jun 2013. 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. Some participants in this study may receive a placebo. 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?
frequency of binge eating (time frame: prior 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2013.