Clinical trial NCT01282736: Guided Self-Help for Binge Eating Disorder
Official title: Comparison of Integrative Response Therapy and Cognitive Behavioral Therapy Guided Self-Help for Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Keywords: eating disorder
binge eating
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.
* Be literate in English (this is required for inclusion because sessions will be conducted in English and written and visual materials are in English).
* Have a Primary Health Care Provider.

Exclusion Criteria:

* Current psychosis or severe depression with suicidal risk; a severity that would likely require additional psychotherapeutic or psychopharmacologic treatment or interfere with participation in this group therapy or with day to day functioning. Depressive disorders not meeting the intensity factor of the exclusion criteria may be entered to the study.
* 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

Primary outcomes:
measure: number of binge days over the previous 28 days
timeFrame: 16 weeks post-treatment
Secondary outcomes:
measure: emotion driven urges to eat
timeFrame: 16 weeks post-treatment, 6 and 12 month follow-up
measure: adaptation time intervals and response accuracy for emotion related stimuli
timeFrame: 16 weeks post-treatment
measure: depression
timeFrame: 16 weeks post-treatment, 6 and 12 month follow-up
measure: self-esteem
timeFrame: 16 weeks post-treatment, 6 and 12 month follow-up
measure: quality of life
timeFrame: post-treatment, 6 and 12 month follow-up
measure: use of health services
timeFrame: at (approximately) 1 month intervals throughout 16 week intervention (4 times total)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Athena Robinson
role: PRINCIPAL_INVESTIGATOR
References: