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

Primary Purpose

Eating Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Family therapy (FT)

Individual therapy (IT)

About this trial

This is an interventional diagnostic trial for Eating Disorders focused on measuring Treatment outcomes study, Anorexia, Anorexia nervosa

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets Diagnostic and Statistical Manual (4th Edition) (DSM-IV) criteria for anorexia nervosa Exclusion Criteria: Any psychotic illness

Sites / Locations

The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Participants will receive family-based treatment

Participants will receive individual adolescent focused therapy

Outcomes

Primary Outcome Measures

Weight (BMI)

Secondary Outcome Measures

Changes in shape and weight concerns as measured with Eating Disorder Examination subscales

Full Information

NCT ID

NCT00183586

First Posted

September 13, 2005

Last Updated

June 16, 2016

Sponsor

University of Chicago

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00183586

Brief Title

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

Official Title

Treatment for Adolescent Anorexia Nervosa

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eating Disorders

Keywords

Treatment outcomes study, Anorexia, Anorexia nervosa

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Participants will receive family-based treatment

Arm Title

Arm Type

Active Comparator

Arm Description

Participants will receive individual adolescent focused therapy

Intervention Type

Behavioral

Intervention Name(s)

Family therapy (FT)

Other Intervention Name(s)

FBT

Intervention Description

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

Intervention Name(s)

Individual therapy (IT)

Other Intervention Name(s)

EOIT or AFT

Intervention Description

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

Primary Outcome Measure Information:

Title

Weight (BMI)

Time Frame

Measured at end-of-treatment and Months 6 and 12 post-treatment

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meets Diagnostic and Statistical Manual (4th Edition) (DSM-IV) criteria for anorexia nervosa Exclusion Criteria: Any psychotic illness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Le Grange, PhD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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