Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa

Phase 3

Completed

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: Family Behavior Therapy; Behavioral: Systems Family Therapy

• Registration Number: NCT00610753
• Lead Sponsor: Stanford University

Brief Summary

This study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.

Detailed Description

The long-term objective of this study is to enhance the treatment and outcome of anorexia nervosa (AN). Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa. The focus of this study is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy called behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Although there have been several small scale studies of BFT there has been no controlled comparison with another form of family therapy. Therefore we propose to use systems family therapy (SFT) which has been developed to represent the type of family therapy practiced in the community.

One hundred and sixty adolescents of both genders aged 12-18 years meeting DSM-IV criteria for anorexia nervosa will be entered to the study. Recruitment is projected to extend for 2 years. Participants will be randomly allocated to one of the two types of family therapy. Family therapy will be given for 36-weeks. For the purpose of the present study, patients will be followed for 12-months after the end of family treatment. Hence, each family will participate for approximately 2-years, with a total participation time of some 40-hours. In a sub-study blood will be drawn from those volunteering for genetic analysis focusing on the subset of non-responders to treatments.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-02-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Diagnosis of anorexia nervosa with Ideal Body Weight >75%

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Exclusion Criteria

Current psychotic illness or mental retardation that would prohibit the use of psychotherapy Medically unstable for outpatient treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Behavioral Therapy	Family Behavior Therapy	This intervention focuses on counseling the parents (and other family members) on refeeding their child. When weight is being steadily regained the focus of therapy shifts to allow the child more independence.
Systems Family Therapy	Systems Family Therapy	This therapy focuses primarily on clarifying psychological processes within the family.

Primary Outcome Measures

Name	Time	Method
Percent Ideal Body Weight (%IBW)	9-months and 21-months	Patients weighed in gowns on calibrated balance beam machines and height assessed with a stadiometer. Percent Ideal Body Weight calculated on a study designed calculator.

Secondary Outcome Measures

Name	Time	Method
Eating Disorder Psychopathology	9 months and 21 months	Eating Disorders Examination obtained in a standardized interview assessing: Binge eating, purging, weight and shape concerns. Assessed as the global measure.

Trial Locations

Locations (7)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

UCSD Center for Eating Disorder Treatment & Research; 🇺🇸 San Diego, California, United States

Sheppard-Pratt Health System; 🇺🇸 Baltimore, Maryland, United States

Washington University, Department of Psychiatry; 🇺🇸 St Louis, Missouri, United States

Department of Psychiatry, Cornell University; 🇺🇸 White Plains, New York, United States

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Laureate Psychiatric Clinic & Hospital; 🇺🇸 Tulsa, Oklahoma, United States