Adaptive Family Treatment for Adolescent Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Adaptive Family Treatment for Adolescent Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579682
• Other study ID #: SPO 49694
• Secondary ID: SPO 49798
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: April 12, 2016
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• 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 English-speaking parent who is willing to participate

• Medically Stable

• Adequate transportation to clinic

• Proficient at speaking, reading, and writing English

Exclusion Criteria:

• Previous FBT for AN

• Medical condition 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

Intervention

Behavioral:
• Family-Based Therapy (FBT)
12 sessions of FBT over the course of 6 months.
• Family-Based Therapy with Intensive Family-Focused treatment
FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full remission from AN (%MBW>95)	Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)	End of Treatment (6 months)	No
Secondary	Changes in subscale scores of the EDE	Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.	End of Treatment (6 months)	No

External Links

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