Family Therapy for Adolescent Bulimia Nervosa

September 4, 2013 updated by: University of Chicago

Family Therapy for Adolescent Bulimia Nervosa: A Controlled Comparison

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Binge eating and purging frequency measured by the Eating Disorder Examination
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
EDE Subscales
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Le Grange, PhD, The University of Chiacgo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

August 17, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 10208 (K23 MH01923)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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