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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

September 6, 2005
April 9, 2012
October 2004
March 2008   (final data collection date for primary outcome measure)
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 ]
  • Scores on the Eating Disorders Examination from baseline to end of treatment
  • Weight increase to 90% or higher from baseline to end of treatment
Complete list of historical versions of study NCT00149786 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa
Treatment of Adolescents With Anorexia Nervosa

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

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Eating Disorders
  • Behavioral: Family Based Therapy
    Family therapy will be given for a total of 24 hours over the course of 12 months.
    Other Name: FBT
  • 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
  • Experimental: 1
    Those adolescents receiving family based therapy
    Intervention: Behavioral: Family Based Therapy
  • Active Comparator: 2
    Those adolescents receiving individual therapy
    Intervention: Behavioral: Ego-Oriented Individual Psychotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2009
March 2008   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149786
R01 MH70621, R01MH070621, DDTR B4-ARE
Yes
Stanford University
Stanford University
National Institute of Mental Health (NIMH)
Principal Investigator: James D. Lock, MD, PhD Stanford University
Stanford University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP