Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00149786
First received: September 6, 2005
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Adolescents With Anorexia Nervosa

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Scores on the Eating Disorders Examination [ Time Frame: Measured at Year 1 of treatment and Year 1 of follow-up ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2004
Study Completion Date: March 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149786

Locations
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
Principal Investigator: James D. Lock, MD, PhD Stanford University
  More Information

Additional Information:
Stanford University Eating Disorders Research information  This link exits the ClinicalTrials.gov site

No publications provided by Stanford University

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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00149786     History of Changes
Other Study ID Numbers: R01 MH70621, R01MH070621, DDTR B4-ARE
Study First Received: September 6, 2005
Last Updated: April 9, 2012
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Anorexia Nervosa
Adolescents
Family therapy
Individual therapy

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Eating Disorders
 Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013