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

NCT ID: NCT00149786

Last Updated: 2012-04-10

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

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-03-31

Brief Summary

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This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of 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 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.

Conditions

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Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Those adolescents receiving family based therapy

Group Type EXPERIMENTAL

Family Based Therapy

Intervention Type BEHAVIORAL

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

2

Those adolescents receiving individual therapy

Group Type ACTIVE_COMPARATOR

Ego-Oriented Individual Psychotherapy

Intervention Type BEHAVIORAL

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

Interventions

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Family Based Therapy

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

Intervention Type BEHAVIORAL

Ego-Oriented Individual Psychotherapy

Individual therapy 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 EOIP

Eligibility Criteria

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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
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

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James D. Lock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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The University of Chicago, Pritzker School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25440306 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20921118 (View on PubMed)

Other Identifiers

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R01MH070621

Identifier Type: NIH

Identifier Source: secondary_id

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DDTR B4-ARE

Identifier Type: -

Identifier Source: secondary_id

R01MH070621

Identifier Type: NIH

Identifier Source: org_study_id

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