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

Eating Disorders Clinical Trial

Official title:

Treatment of Adolescents With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149786
• Other study ID #: R01MH070621
• Secondary ID: R01MH070621DDTR
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2005
• Last updated: April 9, 2012
• Start date: October 2004
• Est. completion date: March 2009

Study information

• Verified date: April 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Eating Disorders

Intervention

Behavioral:
• Family Based Therapy
Family therapy will be given for a total of 24 hours over the course of 12 months.
• Ego-Oriented Individual Psychotherapy
Individual therapy will be given for a total of 24 hours over the course of 12 months.

Locations

Country	Name	City	State
United States	The University of Chicago, Pritzker School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on the Eating Disorders Examination		Measured at Year 1 of treatment and Year 1 of follow-up	No

External Links

•   Stanford University Eating Disorders Research information