Adaptive Family Treatment for Adolescent Anorexia Nervosa

Not Applicable

Completed

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: Family-Based Therapy (FBT); Behavioral: Family-Based Therapy with Intensive Family-Focused treatment

• Registration Number: NCT01579682
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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Exclusion Criteria

• Previous FBT for AN
• Medical condition that may affect eating or weight

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychotherapy	Family-Based Therapy (FBT)	Family-Based Therapy (12 sessions)
Family-Based Therapy with Intensive Family-Focused Treatment	Family-Based Therapy with Intensive Family-Focused treatment	The patient will receive 4 sessions of Family-Based therapy, and if the participant does not make adequate weight gain within this time period, will be assigned to Intensive Family-Focused Therapy (IFT).

Primary Outcome Measures

Name	Time	Method
Full remission from AN (%MBW>95)	End of Treatment (6 months)	Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)

Secondary Outcome Measures

Name	Time	Method
Changes in subscale scores of the EDE	End of Treatment (6 months)	Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.

Trial Locations

Locations (2)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Stanford University; 🇺🇸 Stanford, California, United States