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OpenTrials
Completed

NCT Number: NCT00518843

Family Therapy for Adolescent Bulimia Nervosa

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.

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Key information

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • psychotic illness acute suicidality medical illness that impacts weight pregnant

Treatment and study plan

FBT-BN

Behavioral

Mobilizing parents to curtail binge eating and purging

SPT

Behavioral

Supportive the individual patient to explore factors that might underlie the eating disorder

Primary outcomes

  1. Binge eating and purging frequency measured by the Eating Disorder Examination

    Time frame: 28 days

Secondary outcomes

  1. EDE Subscales

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Family Therapy for Adolescent Bulimia Nervosa: A Controlled Comparison

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Aug 21, 2007
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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