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Completed

NCT Number: NCT00183586

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

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.

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Key information

Conditions

Eating Disorders Anorexia Anorexia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any psychotic illness

Treatment and study plan

Family therapy (FT)

Behavioral

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

Individual therapy (IT)

Behavioral

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

Primary outcomes

  1. Weight (BMI)

    Time frame: Measured at end-of-treatment and Months 6 and 12 post-treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treatment for Adolescent Anorexia Nervosa

Important dates

Study start
2004
Primary completion
2009
First posted
Sep 16, 2005
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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