Guided Self-Help for Binge Eating Disorder
Comparison of Integrative Response Therapy and Cognitive Behavioral Therapy Guided Self-Help for Binge Eating Disorder
1 other identifier
interventional
86
1 country
1
Brief Summary
The proposed study will employ a randomized design to evaluate the efficacy of two group-based guided self-help treatments: Integrative Response Therapy (IRT) and Cognitive Behavior Therapy Guided Self-Help, a treatment of known efficacy, in group-format (CBT-GSHg) in the treatment of Binge Eating Disorder (BED), and explore (1) moderators and mediators of treatment, (2) the relative cost-effectiveness of the two treatments, and (3) between group differences on secondary measures (e.g., eating disorder and general psychopathology).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 14, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 26, 2019
March 1, 2019
4.1 years
January 14, 2011
March 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of binge days over the previous 28 days
Assessed via the Eating Disorder Examination
16 weeks post-treatment
Secondary Outcomes (6)
emotion driven urges to eat
16 weeks post-treatment, 6 and 12 month follow-up
adaptation time intervals and response accuracy for emotion related stimuli
16 weeks post-treatment
depression
16 weeks post-treatment, 6 and 12 month follow-up
self-esteem
16 weeks post-treatment, 6 and 12 month follow-up
quality of life
post-treatment, 6 and 12 month follow-up
- +1 more secondary outcomes
Study Arms (2)
Integrative Response Therapy
EXPERIMENTALIRT is based on affect regulation theories of binge eating and adds emphasis on cognitive restructuring techniques. IRT is a 10 session, group-based, guided-self-help treatment that works to decrease binge eating by primarily enhancing emotion coping skills, in addition to transforming faulty interpretations and reducing vulnerabilities (e.g., interpersonal events) that risk overwhelming emotion and problematic cognitions.
Cognitive Behavioral Therapy
ACTIVE COMPARATORCognitive Behavioral Therapy guided self-help (CBT-GSH), based on the restraint model of binge eating, has been adapted from individual format to a 10 session, group-based therapy for the purpose of this study. The book 'Overcoming Binge Eating' is employed in the present study and consists of Part 1, an educational background on BED, and Part 2, a 6 step treatment program to overcome binge eating.
Interventions
A 10 session manualized version of IRT is employed . Each of the 10 group therapy sessions will be 60 minutes in length. Non-specialty trained Masters-level therapists will lead IRT after undergoing IRT training with the PI.
A 10 session manualized version of CBT-GSH is employed . Each of the 10 group therapy sessions will be 60 minutes in length. Non-specialty trained Masters-level therapists will lead CBT-GSH after undergoing CBT-GSH training with the PI.
Eligibility Criteria
You may qualify if:
- Meet DSM-IV research criteria for Binge Eating Disorder (although frequency criteria will be lessened to that proposed in DSM-V;1 time per week for 3 months).
- Be male or female between 18 and 75 years.
- Be available and committed to attend full treatment and follow-up
- Adequate transportation to the clinic.
- Have a Primary Health Care Provider.
You may not qualify if:
- Current Anorexia or Bulimia Nervosa or purging behaviors over the past six months.
- Current drug and/or alcohol abuse/dependence.
- Current medication primarily indicated for its effect on appetite or weight, unless the participant is willing to withdraw from such medications under supervision of their primary care physician.
- Current chemotherapy.
- Current participation in psychotherapy, unless the participant is willing to discontinue treatment.
- Psychotropic medication use, including antidepressants, are acceptable if doses were stable for at least 1 month prior to assessment.
- Pregnant or plans to become pregnant within the next 12 months.
- BMI greater than 45.
- Planning to have Bariatric surgery within the next 12 months.
- No transportation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athena Robinson
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2011
First Posted
January 25, 2011
Study Start
June 1, 2010
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 26, 2019
Record last verified: 2019-03