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

Eating Disorders Clinical Trial

Official title:

Treatment for Adolescent Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183586
• Other study ID #: R01MH070620
• Secondary ID: R01MH070620DDTR
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 16, 2016
• Start date: April 2004

Study information

• Verified date: June 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Any psychotic illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Eating Disorders
• Feeding and Eating Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (BMI)		Measured at end-of-treatment and Months 6 and 12 post-treatment	No
Secondary	Changes in shape and weight concerns as measured with Eating Disorder Examination subscales		Measured at end-of-treatment and Months 6 and 12 post-treatment	No