Family Therapy for Adolescent Bulimia Nervosa

Bulimia Nervosa Clinical Trial

Official title:

Family Therapy for Adolescent Bulimia Nervosa: A Controlled Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518843
• Other study ID #: 10208 (K23 MH01923)
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2007
• Last updated: September 4, 2013
• Start date: April 2001
• Est. completion date: May 2006

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• psychotic illness acute suicidality medical illness that impacts weight pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

Intervention

Behavioral:
• FBT-BN
Mobilizing parents to curtail binge eating and purging
• SPT
Supportive the individual patient to explore factors that might underlie the eating disorder

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge eating and purging frequency measured by the Eating Disorder Examination		28 days
Secondary	EDE Subscales		28 days

External Links

•   Eating Disorders Website, University of Chicago, Summary of protocol