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Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa

Primary Purpose

Eating Disorders

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Family Based Therapy

Ego-Oriented Individual Psychotherapy

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Anorexia Nervosa, Adolescents, Family therapy, Individual therapy

Eligibility Criteria

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

Inclusion Criteria: Meets DSM-IV criteria for anorexia nervosa Lives with at least one parent who is willing to participate Medically stable Adequate transportation to clinic Proficient at speaking, reading, and writing English Exclusion Criteria: Currently undergoing treatment or taking medication that may affect eating or weight

Sites / Locations

The University of Chicago, Pritzker School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Those adolescents receiving family based therapy

Those adolescents receiving individual therapy

Outcomes

Primary Outcome Measures

Scores on the Eating Disorders Examination

Secondary Outcome Measures

Full Information

NCT ID

NCT00149786

First Posted

September 6, 2005

Last Updated

April 9, 2012

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00149786

Brief Title

Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa

Official Title

Treatment of Adolescents With Anorexia Nervosa

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of 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 the effectiveness of family-based therapy versus ego-oriented individual psychotherapy for the treatment of adolescent anorexia nervosa. Simultaneously, it will examine potential predictors, mediators, and moderators of weight gain, psychological concerns about weight and shape, and changes in family functioning. Participants in this open-label study will be randomly assigned to receive one of two types of therapy: family-based therapy or ego-oriented individual psychotherapy. Both types of therapy will be given for a total of 24 hours over the course of 12 months. Physical and psychological assessments will be completed during study visits at baseline, immediately post-treatment, six months post-treatment, and one year post-treatment. Amount of weight gain will be evaluated, along with changes in weight and body shape concerns, as measured by the Eating Disorder Examination.

6. Conditions and Keywords

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

Eating Disorders

Keywords

Anorexia Nervosa, Adolescents, Family therapy, Individual therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Those adolescents receiving family based therapy

Arm Title

Arm Type

Active Comparator

Arm Description

Those adolescents receiving individual therapy

Intervention Type

Behavioral

Intervention Name(s)

Family Based Therapy

Other Intervention Name(s)

FBT

Intervention Description

Family therapy will be given for a total of 24 hours over the course of 12 months.

Intervention Type

Behavioral

Intervention Name(s)

Ego-Oriented Individual Psychotherapy

Other Intervention Name(s)

EOIP

Intervention Description

Individual therapy will be given for a total of 24 hours over the course of 12 months.

Primary Outcome Measure Information:

Title

Scores on the Eating Disorders Examination

Time Frame

Measured at Year 1 of treatment and Year 1 of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James D. Lock, MD, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Chicago, Pritzker School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25440306

Citation

Le Grange D, Lock J, Accurso EC, Agras WS, Darcy A, Forsberg S, Bryson SW. Relapse from remission at two- to four-year follow-up in two treatments for adolescent anorexia nervosa. J Am Acad Child Adolesc Psychiatry. 2014 Nov;53(11):1162-7. doi: 10.1016/j.jaac.2014.07.014. Epub 2014 Aug 23.

Results Reference

derived

PubMed Identifier

20921118

Citation

Lock J, Le Grange D, Agras WS, Moye A, Bryson SW, Jo B. Randomized clinical trial comparing family-based treatment with adolescent-focused individual therapy for adolescents with anorexia nervosa. Arch Gen Psychiatry. 2010 Oct;67(10):1025-32. doi: 10.1001/archgenpsychiatry.2010.128.

Results Reference

derived

Links:

URL

http://psychiatry.stanford.edu/research/eating.html

Description

Stanford University Eating Disorders Research information

Learn more about this trial

Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa

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