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Guided Self-Help for Binge Eating Disorder

Primary Purpose

Binge Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrative Response Therapy
Cognitive Behavioral Therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring eating disorder, binge eating

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrative Response Therapy

Cognitive Behavioral Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

number of binge days over the previous 28 days
Assessed via the Eating Disorder Examination

Secondary Outcome Measures

emotion driven urges to eat
Assessed via the Emotional Eating Scale
adaptation time intervals and response accuracy for emotion related stimuli
Assessed via the Emotion Conflict Adaptation Task
depression
Assessed via the Beck Depression Inventory
self-esteem
Assessed via the Rosenberg Self-Esteem Scale
quality of life
Assessed via the Quality of Well-Being Scale
use of health services
Assessed via the Health Care Diary

Full Information

First Posted
January 14, 2011
Last Updated
March 22, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01282736
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder
Keywords
eating disorder, binge eating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrative Response Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrative Response Therapy
Intervention Description
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
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of binge days over the previous 28 days
Description
Assessed via the Eating Disorder Examination
Time Frame
16 weeks post-treatment
Secondary Outcome Measure Information:
Title
emotion driven urges to eat
Description
Assessed via the Emotional Eating Scale
Time Frame
16 weeks post-treatment, 6 and 12 month follow-up
Title
adaptation time intervals and response accuracy for emotion related stimuli
Description
Assessed via the Emotion Conflict Adaptation Task
Time Frame
16 weeks post-treatment
Title
depression
Description
Assessed via the Beck Depression Inventory
Time Frame
16 weeks post-treatment, 6 and 12 month follow-up
Title
self-esteem
Description
Assessed via the Rosenberg Self-Esteem Scale
Time Frame
16 weeks post-treatment, 6 and 12 month follow-up
Title
quality of life
Description
Assessed via the Quality of Well-Being Scale
Time Frame
post-treatment, 6 and 12 month follow-up
Title
use of health services
Description
Assessed via the Health Care Diary
Time Frame
at (approximately) 1 month intervals throughout 16 week intervention (4 times total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athena Robinson
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Links:
URL
http://psychiatry.stanford.edu/research/eating.html
Description
For further study related information, please visit this website.

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Guided Self-Help for Binge Eating Disorder

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