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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00149786
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 10, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of adolescent anorexia nervosa.

Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: Family Based Therapy Behavioral: Ego-Oriented Individual Psychotherapy Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Adolescents With Anorexia Nervosa
Study Start Date : October 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Those adolescents receiving family based therapy
 Behavioral: Family Based Therapy
Family therapy will be given for a total of 24 hours over the course of 12 months.
Other Name: FBT
Active Comparator: 2
Those adolescents receiving individual therapy
 Behavioral: Ego-Oriented Individual Psychotherapy
Individual therapy will be given for a total of 24 hours over the course of 12 months.
Other Name: EOIP


Outcome Measures
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Primary Outcome Measures :
  1. Scores on the Eating Disorders Examination [ Time Frame: Measured at Year 1 of treatment and Year 1 of follow-up ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149786


Locations
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United States, Illinois
The University of Chicago, Pritzker School of Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: James D. Lock, MD, PhD Stanford University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00149786    
Other Study ID Numbers: R01MH070621 ( U.S. NIH Grant/Contract )
R01MH070621 ( U.S. NIH Grant/Contract )
DDTR B4-ARE
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Stanford University:
Anorexia Nervosa
Adolescents
Family therapy
Individual therapy
Additional relevant MeSH terms:
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Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive