Study of Treatment for Adolescents With Bulimia Nervosa

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00879151
First received: April 7, 2009
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

In the face of scant literature on the subject, the investigators aim to more clearly identify effective treatments for adolescent bulimia nervosa (BN) through a treatment study comparing two current treatments (Cognitive Behavioral Therapy for Adolescents, CBT-A and Family Based Therapy for Bulimia Nervosa, FBT-BN) for the disorder in comparison with a non-specific therapy, Supportive Psychotherapy for Adolescent Bulimia (SPT). Additionally, the investigators hope to provide clinicians with information on treatment efficacy, variables that might influence outcome, and processes that may affect treatment efficacy that will guide them in their efforts to treat adolescent BN.


Condition Intervention
Bulimia
Behavioral: Cognitive Behavioral Therapy for Adolescents
Behavioral: Supportive Psychotherapy
Behavioral: Family Based Therapy for Bulimia Nervosa

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Bulimic Adolescents

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Binge and purge frequency as assessed by the Eating Disorder Examination (EDE) [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the subscale scores of the EDE [ Time Frame: End of Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 158
Study Start Date: January 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychotherapy
Patients are randomized to one of three different types of psychotherapy: Cognitive-Behavioral Therapy for adolescents, Family-Based Therapy for Bulimia Nervosa, and Supportive Psychotherapy. All treatments consist of 18 sessions over a period of approximately 6 months.
Behavioral: Cognitive Behavioral Therapy for Adolescents
The therapist will work with the adolescent to understand triggers to binge eating and purging, such as thoughts, feelings, and interpersonal difficulties. Also, establishing regular eating patterns and eliminating medically harmful behaviors associated with the eating disorder is a primary goal.
Behavioral: Supportive Psychotherapy
SPT focuses on having the patient build a relationship with the therapist and explore their unique individual needs within the context of their life and the experience of having an eating disorder.
Behavioral: Family Based Therapy for Bulimia Nervosa
FBT helps parents to take an active role in guiding their child through eating disorder treatment. In this therapy, the parents are supported in helping their child stop bingeing, purging and engaging in other harmful weight-control behaviors. The way in which the eating disorder has impacted the family and the adolescent's development is also explored.

Detailed Description:

BN is a serious disorder that is characterized by extreme concerns about body weight and shape, dieting, and the disinhibited eating behaviors of binging and purging. There are no published randomized clinical trials of psychotherapy treatment for Bulimia Nervosa in adolescents although it often onsets in this age group. There is evidence that some treatments are effective, but none has been empirically tested. Because Bulimia Nervosa is a serious medical and psychiatric illness it is important to learn efficacious ways to treat this disorder, especially in its early stages. Treatments used in this study are the best known treatments for adults with Bulimia Nervosa. The investigators hope to learn which of two previously studied treatments might be superior to the other, in an effort to guide clinicians in treatment choices. Successfully treating the disorder early on (even in those adolescents with partial BN, characterized by binge eating and purging at least one time per week over a 6 month period) may reduce the number of cases requiring treatment during adulthood, leading to possible reduction in severity of associated psychopathology and lower costs, as well as enable individuals to lead more productive lives.

Given the neglect of adolescent BN in the research literature and the need for information to guide the clinical treatment of this disorder, this study's primary aim is to compare the efficacy of CBT-A to FBT-BN in decreasing binge eating and purging episodes in adolescents with BN and partial BN (defined as binge eating and purging at least one time per week for the past six months).

Participation in this study will last 1 and a half years and will consist of 6 months of treatment and a follow-up session at 6 and 12 months post-treatment. All participants will first undergo baseline assessments, which include interviews and questionnaires about psychological history and BN symptoms, and an Eating Disorder Examination (EDE) interview. All treatment assignments consist of 18 sessions of therapy over the course of 6 months.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants will be adolescents living with at least one of their parents and between the ages of 12 and 18 years of age with a DSM IV diagnosis of BN or partial BN (binge eating and purging at least one time per week over a six month period).
  2. Males meeting inclusion criteria will also be entered into the study. They must have age-adjusted BMI greater than 17.5, or ideal body weight (IBW) > 85%.
  3. Family, for the purposes of this study, includes members of the subject's household, including at least one parent or adult guardian. Single parent families, divorced families, step-parents, and other types of families will be allowed to enter the study.

Exclusion Criteria:

  1. psychotic illness or other mental illness requiring hospitalization; bipolar I disorder, depression with active suicidal thoughts and behavior;
  2. associated physical illness that necessitates hospitalization;
  3. current dependence on drugs or alcohol;
  4. current diagnosis of anorexia nervosa or weight less that 85% IBW;
  5. physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight;
  6. currently taking medication for co-morbid conditions for less than 2-months;
  7. currently taking medications that may induce weight loss, e.g., appetite suppressants such as sibutramine, phentermine, and xenical, unless the participant is willing to withdraw from such medications;
  8. currently taking medications for symptoms of BN and unwilling to discontinue these prior to initiating treatment in the study
  9. previous CBT or FBT treatment for BN
  10. married subjects
  11. emancipated minors
  12. family members will be excluded from engaging in treatment for the following reasons:

    • Current or history of sexual or physical abuse of the patient by family members. Perpetrators of the abuse will be excluded from treatment. Should sexual or physical abuse by a family member occur during the course of treatment, perpetrators will be excluded from ongoing treatment.
    • Substance dependence, psychosis, or severe medical illness that would limit full participation in therapy, or that might put the family member at risk for worsening of their condition during treatment. The decision whether or not to allow these individuals to continue to participate in treatment will be made by the therapist in consultation with the treatment supervisor.
  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: NCT00879151

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Stanford University
University of Chicago
Investigators
Principal Investigator: James D Lock Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00879151     History of Changes
Other Study ID Numbers: SU-02272009-1878, eProtocol Number 132056
Study First Received: April 7, 2009
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bulimia
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014