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

NCT ID: NCT00183586

Last Updated: 2016-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Participants will receive family-based treatment

Group Type EXPERIMENTAL

Family therapy (FT)

Intervention Type BEHAVIORAL

FT is a family-based treatment that will be given for a total of 24 hours over the course of 12 months.

2

Participants will receive individual adolescent focused therapy

Group Type ACTIVE_COMPARATOR

Individual therapy (IT)

Intervention Type BEHAVIORAL

IT is an ego-oriented psychotherapy treatment that will be given for a total of 24 hours over the course of 12 months.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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FBT EOIT or AFT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Any psychotic illness
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Le Grange, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH070620

Identifier Type: NIH

Identifier Source: secondary_id

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DDTR B4-ARE

Identifier Type: -

Identifier Source: secondary_id

R01MH070620

Identifier Type: NIH

Identifier Source: org_study_id

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