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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00183586
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 20, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Eating Disorders Behavioral: Family therapy (FT) Behavioral: Individual therapy (IT) Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Treatment for Adolescent Anorexia Nervosa
Study Start Date : April 2004
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Weight (BMI) [ Time Frame: Measured at end-of-treatment and Months 6 and 12 post-treatment ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183586


Locations
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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
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Principal Investigator: Daniel Le Grange, PhD University of Chicago
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00183586    
Other Study ID Numbers: R01MH070620 ( U.S. NIH Grant/Contract )
R01MH070620 ( U.S. NIH Grant/Contract )
DDTR B4-ARE
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Keywords provided by University of Chicago:
Treatment outcomes study
Anorexia
Anorexia nervosa
Additional relevant MeSH terms:
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Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive