Comparing the Effectiveness of Three Types of Therapy for the Treatment of Anorexia Nervosa in Adolescents
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ClinicalTrials.gov Identifier: NCT00183586 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : June 20, 2016
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Condition or disease | Intervention/treatment | Phase |
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Eating Disorders | Behavioral: Family therapy (FT) Behavioral: Individual therapy (IT) | Phase 2 |
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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Participants will receive family-based treatment
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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
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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 |
- Weight (BMI) [ Time Frame: Measured at end-of-treatment and Months 6 and 12 post-treatment ]
- 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 ]

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Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meets Diagnostic and Statistical Manual (4th Edition) (DSM-IV) criteria for anorexia nervosa
Exclusion Criteria:
- Any psychotic illness

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
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Daniel Le Grange, PhD | University of Chicago |
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 |
Treatment outcomes study Anorexia Anorexia nervosa |
Anorexia Feeding and Eating Disorders Anorexia Nervosa Mental Disorders Signs and Symptoms, Digestive |