Family Therapy for Adolescent Bulimia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518843
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : September 5, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Behavioral: FBT-BN Behavioral: SPT Phase 2

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:

  1. To adapt and pilot a recently developed family therapy manual for adolescent AN for use in the treatment of adolescent BN patients.
  2. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family Therapy for Adolescent Bulimia Nervosa: A Controlled Comparison
Study Start Date : April 2001
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: FBT-BN
Family-based treatment
Behavioral: FBT-BN
Mobilizing parents to curtail binge eating and purging
Active Comparator: SPT
Individual Supportive Psychotherapy
Behavioral: SPT
Supportive the individual patient to explore factors that might underlie the eating disorder

Primary Outcome Measures :
  1. Binge eating and purging frequency measured by the Eating Disorder Examination [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. EDE Subscales [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • DSM-IV criteria for bulimia nervosa or partial bulimia nervosa

Exclusion Criteria:

  • psychotic illness acute suicidality medical illness that impacts weight pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00518843

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institute of Mental Health (NIMH)
Principal Investigator: Daniel Le Grange, PhD The University of Chiacgo

Additional Information:
Responsible Party: University of Chicago Identifier: NCT00518843     History of Changes
Other Study ID Numbers: 10208 (K23 MH01923)
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
binge eating

Additional relevant MeSH terms:
Bulimia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders