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Clinical Trials/NCT00610753
NCT00610753CompletedPhase 3

Family Therapy in the Treatment of Adolescent Anorexia Nervosa

Stanford University7 sites in 2 countries164 target enrollmentStarted: July 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
164
Locations
7
Primary Endpoint
Percent Ideal Body Weight (%IBW)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of anorexia nervosa with Ideal Body Weight >75%

Exclusion Criteria

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

Arms & Interventions

Family Behavioral Therapy

Experimental

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.

Intervention: Family Behavior Therapy (Behavioral)

Systems Family Therapy

Active Comparator

This therapy focuses primarily on clarifying psychological processes within the family.

Intervention: Systems Family Therapy (Behavioral)

Outcomes

Primary Outcomes

Percent Ideal Body Weight (%IBW)

Time Frame: 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 Outcomes

  • Eating Disorder Psychopathology(9 months and 21 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

William Stewart Agras

Professor Emeritus

Stanford University

Study Sites (7)

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