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Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa
This study is ongoing, but not recruiting participants.

First Received on January 25, 2008.   Last Updated on August 23, 2010   History of Changes
Sponsor: Stanford University
Collaborator: National Institute of Mental Health (NIMH)
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00610753
  Purpose

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


Condition Intervention Phase
Anorexia Nervosa
Behavioral: Family therapy
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family Therapy in the Treatment of Adolescent Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percent Ideal Body Weight (%IBW) [ Time Frame: 9-months and 21-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eating Disorder Psychopathology [ Time Frame: 9 months and 21 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: July 2006
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610753

Locations
United States, California
UCSD Center for Eating Disorder Treatment & Research
San Diego, California, United States, 92037
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Maryland
Sheppard-Pratt Health System
Baltimore, Maryland, United States, 21204
United States, Missouri
Washington University, Department of Psychiatry
St Louis, Missouri, United States, 63110
United States, New York
Department of Psychiatry, Cornell University
White Plains, New York, United States, 10605
United States, Oklahoma
Laureate Psychiatric Clinic & Hospital
Tulsa, Oklahoma, United States, 74136
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: William Stewart Agras Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: William Stewart Agras, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00610753     History of Changes
Other Study ID Numbers: SU-12132007-933, 5 U01 MH076290; SPO#33857
Study First Received: January 25, 2008
Last Updated: August 23, 2010
Health Authority: US:U.S: Institutional Review Board

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012