Guided Self-Help for Binge Eating Disorder
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|ClinicalTrials.gov Identifier: NCT01282736|
Recruitment Status : Unknown
Verified May 2013 by Athena Robinson, Stanford University.
Recruitment status was: Active, not recruiting
First Posted : January 25, 2011
Last Update Posted : May 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Binge Eating Disorder||Behavioral: Integrative Response Therapy Behavioral: Cognitive Behavioral Therapy||Not Applicable|
The focus of this proposal is on BED among an adult population. Guided self-help treatments (GSH) for BED appear promising and may be more readily disseminated than efficacious specialty treatments such as Cognitive Behavioral Therapy (CBT) and Interpersonal Psychotherapy (IPT) given the latter's administration costs and time requirements. The proposed study uses a new group-based, guided self-help BED treatment called Integrative Response Therapy (IRT). IRT is primarily based upon the affect regulation theory of binge eating (e.g., binge eating is an attempt to alter distressing emotional states), while adding cognitive restructuring techniques. IRT teaches effective ways to cope with aversive emotions and reframe faulty cognitions while reducing vulnerabilities that are likely to lead to problematic emotional responding & cognitions such as physical needs (e.g., hunger, sleep deprivation), interpersonal conflict, and, when possible, unpleasant external events. IRT's primary goal is to significantly decrease episodes of binge eating and associated eating disorder pathology.
CBT-GSH is a frequently used manual-based form of GSH that has demonstrated efficacy. CBT, based on the restraint model, intervenes via behavioral techniques to replace restrained eating with more regular eating patterns and cognitive techniques to restructure an individual's problematic thoughts that over-evaluate shape and weight. Research literature indicates that CBT-GSH is a viable self-help BED treatment that appears to be superior to wait-list control conditions, equivalent to IPT, a specialty treatment, and superior to Behavioral Weight Loss treatment at 2-year follow-up. There are then, a number of reasons for further research on GSH in general and CBT-gsh specifically.
The proposed study will lay the groundwork for identifying which GSH treatment should be investigated in a subsequent, larger trial that would evaluate a clinically relevant algorithm for the treatment of BED.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Integrative Response Therapy and Cognitive Behavioral Therapy Guided Self-Help for Binge Eating Disorder|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||May 2015|
Experimental: Integrative Response Therapy
IRT 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.
Behavioral: Integrative Response Therapy
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.
Active Comparator: Cognitive Behavioral Therapy
Cognitive 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.
Behavioral: Cognitive Behavioral Therapy
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.
- number of binge days over the previous 28 days [ Time Frame: 16 weeks post-treatment ]Assessed via the Eating Disorder Examination
- emotion driven urges to eat [ Time Frame: 16 weeks post-treatment, 6 and 12 month follow-up ]Assessed via the Emotional Eating Scale
- adaptation time intervals and response accuracy for emotion related stimuli [ Time Frame: 16 weeks post-treatment ]Assessed via the Emotion Conflict Adaptation Task
- depression [ Time Frame: 16 weeks post-treatment, 6 and 12 month follow-up ]Assessed via the Beck Depression Inventory
- self-esteem [ Time Frame: 16 weeks post-treatment, 6 and 12 month follow-up ]Assessed via the Rosenberg Self-Esteem Scale
- quality of life [ Time Frame: post-treatment, 6 and 12 month follow-up ]Assessed via the Quality of Well-Being Scale
- use of health services [ Time Frame: at (approximately) 1 month intervals throughout 16 week intervention (4 times total) ]Assessed via the Health Care Diary
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): NCT01282736
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Athena Robinson||Stanford University|