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Completed

NCT Number: NCT01282736

Guided Self-Help for Binge Eating Disorder

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrative Response Therapy

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

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.

Primary outcomes

  1. number of binge days over the previous 28 days

    Time frame: 16 weeks post-treatment

    Assessed via the Eating Disorder Examination

Secondary outcomes

  1. emotion driven urges to eat

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

    Assessed via the Emotional Eating Scale

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

    Time frame: 16 weeks post-treatment

    Assessed via the Emotion Conflict Adaptation Task

  3. depression

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

    Assessed via the Beck Depression Inventory

  4. self-esteem

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

    Assessed via the Rosenberg Self-Esteem Scale

  5. quality of life

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

    Assessed via the Quality of Well-Being Scale

  6. use of health services

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

    Assessed via the Health Care Diary

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Comparison of Integrative Response Therapy and Cognitive Behavioral Therapy Guided Self-Help for Binge Eating Disorder

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 25, 2011
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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