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Comparing the Effectiveness of Three Types of Therapy for the Treatment of Anorexia Nervosa in Adolescents

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00183586
First received: September 13, 2005
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
This study will compare specific family therapy, standard family systems therapy, and standard individual psychotherapy to determine which is most effective in treating adolescent anorexia nervosa.

Condition Intervention Phase
Eating Disorders
Behavioral: Family therapy (FT)
Behavioral: Individual therapy (IT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Treatment for Adolescent Anorexia Nervosa

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Weight (BMI) [ Time Frame: Measured at end-of-treatment and Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in shape and weight concerns as measured with Eating Disorder Examination subscales [ Time Frame: Measured at end-of-treatment and Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: April 2004
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive family-based treatment
Behavioral: Family therapy (FT)
FT is a family-based treatment that will be given for a total of 24 hours over the course of 12 months.
Other Name: FBT
Active Comparator: 2
Participants will receive individual adolescent focused therapy
Behavioral: Individual therapy (IT)
IT is an ego-oriented psychotherapy treatment that will be given for a total of 24 hours over the course of 12 months.
Other Name: EOIT or AFT

Detailed Description:

In adolescents, anorexia nervosa severely affects physical, emotional, and social development. Despite the seriousness and prevalence of adolescent anorexia nervosa, few studies have focused on the effectiveness of various types of psychotherapy treatment. Family-based therapy may be an effective approach to treating adolescent anorexia nervosa. This study will compare specific family therapy (FT), standard family systems therapy (FS), and standard individual psychotherapy (IT) to determine which is most effective in treating adolescent anorexia nervosa. The study also aims to determine potential predictors and moderators of outcomes, as well as the cost-benefit ratio of each treatment.

Participants in this open-label study will be randomly assigned to one of three treatment groups. Group 1 will receive FT, Group 2 will receive FS, and Group 3 will receive IT. All participants will receive a total of 24 hours of their assigned therapy over a period of 12 months. Study visits will occur at baseline, immediately post-intervention, and again six months and one year post-intervention. Weight change will be assessed, as well as changes in concerns about weight and shape. The cost-benefit ratio of the treatments will also be evaluated.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets Diagnostic and Statistical Manual (4th Edition) (DSM-IV) criteria for anorexia nervosa

Exclusion Criteria:

  • Any psychotic illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183586

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Daniel Le Grange, PhD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00183586     History of Changes
Other Study ID Numbers: R01MH070620  DDTR B4-ARE 
Study First Received: September 13, 2005
Last Updated: June 16, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
Treatment outcomes study
Anorexia
Anorexia nervosa

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

ClinicalTrials.gov processed this record on September 28, 2016