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| 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 |
| 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) |
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 |
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| 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 | |
| Principal Investigator: | William Stewart Agras | Stanford University |
More Information
| 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 |
|
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive |
Signs and Symptoms Eating Disorders Mental Disorders |