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

June 16, 2016 updated by: University of Chicago

Treatment for Adolescent Anorexia Nervosa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Any psychotic illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • EOIT or AFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight (BMI)
Time Frame: Measured at end-of-treatment and Months 6 and 12 post-treatment
Measured at end-of-treatment and Months 6 and 12 post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured at end-of-treatment and Months 6 and 12 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Daniel Le Grange, PhD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 16, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH070620 (U.S. NIH Grant/Contract)
  • DDTR B4-ARE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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