Guided Self-Help for Binge Eating Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Athena Robinson, Stanford University
ClinicalTrials.gov Identifier:
NCT01282736
First received: January 14, 2011
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention
Binge Eating Disorder
Behavioral: Integrative Response Therapy
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Integrative Response Therapy and Cognitive Behavioral Therapy Guided Self-Help for Binge Eating Disorder

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • number of binge days over the previous 28 days [ Time Frame: 16 weeks post-treatment ] [ Designated as safety issue: No ]
    Assessed via the Eating Disorder Examination


Secondary Outcome Measures:
  • emotion driven urges to eat [ Time Frame: 16 weeks post-treatment, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    Assessed via the Emotional Eating Scale

  • adaptation time intervals and response accuracy for emotion related stimuli [ Time Frame: 16 weeks post-treatment ] [ Designated as safety issue: No ]
    Assessed via the Emotion Conflict Adaptation Task

  • depression [ Time Frame: 16 weeks post-treatment, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    Assessed via the Beck Depression Inventory

  • self-esteem [ Time Frame: 16 weeks post-treatment, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    Assessed via the Rosenberg Self-Esteem Scale

  • quality of life [ Time Frame: post-treatment, 6 and 12 month follow-up ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Assessed via the Health Care Diary


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282736

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Athena Robinson Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Athena Robinson, Instructor, Stanford University
ClinicalTrials.gov Identifier: NCT01282736     History of Changes
Other Study ID Numbers: SU-01122011-7362
Study First Received: January 14, 2011
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
eating disorder
binge eating

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014