Guided Self-Help for Binge Eating Disorder

NCT ID: NCT01282736

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Binge Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Integrative Response Therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athena Robinson

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-01122011-7362

Identifier Type: -

Identifier Source: org_study_id