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Family Therapy for Adolescent Bulimia Nervosa

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ClinicalTrials.gov Identifier: NCT00518843
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : September 5, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

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 Design

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
Primary Completion Date : May 2006
Study Completion Date : May 2006
Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00518843


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

Additional Information:
Responsible Party: University of Chicago
ClinicalTrials.gov 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
purging

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