Family Therapy for Adolescent Bulimia Nervosa
Primary Purpose
Bulimia Nervosa
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FBT-BN
SPT
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa focused on measuring binge eating, purging
Eligibility Criteria
Inclusion Criteria:
- DSM-IV criteria for bulimia nervosa or partial bulimia nervosa
Exclusion Criteria:
- psychotic illness acute suicidality medical illness that impacts weight pregnant
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FBT-BN
SPT
Arm Description
Family-based treatment
Individual Supportive Psychotherapy
Outcomes
Primary Outcome Measures
Binge eating and purging frequency measured by the Eating Disorder Examination
Secondary Outcome Measures
EDE Subscales
Full Information
NCT ID
NCT00518843
First Posted
August 17, 2007
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00518843
Brief Title
Family Therapy for Adolescent Bulimia Nervosa
Official Title
Family Therapy for Adolescent Bulimia Nervosa: A Controlled Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary hypotheses are:
A procedurally distinct family therapy is an effective and essential way to reduce bingeing and purging in adolescents with BN, and leads to the long-term amelioration of bulimic symptoms.
Family therapy is an effective way to bring about meaningful improvements in family interaction.
Family therapy will produce significantly larger reductions in bulimic symptoms and improved family interaction in adolescents with BN compared to a control supportive psychotherapy.
Detailed Description
Bulimia nervosa (BN) is a disabling eating disorder and affects as many as 2% of young women. It is a major source of psychiatric and medical morbidity that often impairs several areas of functioning. Even more alarming is the fact that BN is occurring with increasing frequency among adolescents and preadolescents. Applying stringent diagnostic criteria for BN, studies have found 2-5% of adolescent girls surveyed qualify for diagnosis of BN. Research specific to treatment of child and adolescent eating disorders remains limited. No psychological treatment has been systematically evaluated in the treatment of adolescents with BN. However, a series of studies from the Maudsley Hospital in London have shown that family therapy (the 'Maudsley Approach') is effective in the treatment of adolescents with anorexia nervosa (AN). These studies have shown that involving the parents and siblings in treatment has beneficial effects on reversing the course of the eating disorder as well as improving family interaction. A preliminary report from the Maudsley group has also shown that the 'Maudsley Approach' may be helpful in the treatment of adolescents with BN. Because most young adolescents still live with their families of origin, this raises the interesting clinical question that adolescent BN patients can also be successfully treated with family therapy.
The proposed study has two specific aims:
To adapt and pilot a recently developed family therapy manual for adolescent AN for use in the treatment of adolescent BN patients.
To compare the efficacy of this conceptually and procedurally distinct family therapy treatment with individual control psychotherapy.
To achieve these aims, we propose a five-year controlled treatment study to be carried out at The University of Chicago. Eighty newly referred adolescent patients meeting DSM-IV diagnostic criteria for BN will be randomly allocated to one of two groups: 1) family therapy or 2) the individual supportive control treatment. All patients will receive the same medical evaluation and monitoring throughout the study period. Assessment of psychiatric and medical outcome measures will be carried out at the onset of treatment, during treatment, at the end of treatment, and again at one-year follow-up. The clinical outcome variables assessed will include the EDE, KSADS, RSE, and EE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
binge eating, purging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FBT-BN
Arm Type
Experimental
Arm Description
Family-based treatment
Arm Title
SPT
Arm Type
Active Comparator
Arm Description
Individual Supportive Psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
FBT-BN
Intervention Description
Mobilizing parents to curtail binge eating and purging
Intervention Type
Behavioral
Intervention Name(s)
SPT
Intervention Description
Supportive the individual patient to explore factors that might underlie the eating disorder
Primary Outcome Measure Information:
Title
Binge eating and purging frequency measured by the Eating Disorder Examination
Time Frame
28 days
Secondary Outcome Measure Information:
Title
EDE Subscales
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV criteria for bulimia nervosa or partial bulimia nervosa
Exclusion Criteria:
psychotic illness acute suicidality medical illness that impacts weight pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Le Grange, PhD
Organizational Affiliation
The University of Chiacgo
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Family Therapy for Adolescent Bulimia Nervosa
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