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CompletedNCT01282736Updated Mar 26, 2019

Guided Self-Help for Binge Eating Disorder

An interventional study of Integrative Response Therapy and Cognitive Behavioral Therapy in Binge Eating Disorder, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jun 2010, registered Jan 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Binge Eating Disorder

Keywords

  • eating disorder
  • binge eating
03

In context

Bulimia

319 studies on the registry are indexed under Bulimia; 53 are open to participants now.

This study's enrollment of 86 is above the median of 61 across 249 interventional studies indexed under Bulimia.

Browse Bulimia studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralIntegrative 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.

  • BehavioralCognitive 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.

06

What researchers measure

Primary outcomes

  1. number of binge days over the previous 28 days

    Assessed via the Eating Disorder Examination

    Time frame: 16 weeks post-treatment

Secondary outcomes

  1. emotion driven urges to eat

    Assessed via the Emotional Eating Scale

    Time frame: 16 weeks post-treatment, 6 and 12 month follow-up

  2. adaptation time intervals and response accuracy for emotion related stimuli

    Assessed via the Emotion Conflict Adaptation Task

    Time frame: 16 weeks post-treatment

  3. depression

    Assessed via the Beck Depression Inventory

    Time frame: 16 weeks post-treatment, 6 and 12 month follow-up

  4. self-esteem

    Assessed via the Rosenberg Self-Esteem Scale

    Time frame: 16 weeks post-treatment, 6 and 12 month follow-up

  5. quality of life

    Assessed via the Quality of Well-Being Scale

    Time frame: post-treatment, 6 and 12 month follow-up

  6. use of health services

    Assessed via the Health Care Diary

    Time frame: at (approximately) 1 month intervals throughout 16 week intervention (4 times total)

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01282736
Lead sponsor
Stanford University
Responsible party
Sponsor
First posted
Jan 25, 2011
Start date
Jun 2010
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Mar 26, 2019

Study contacts

Athena Robinson
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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