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Adaptive Family Treatment for Adolescent Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT01579682
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : April 13, 2016
University of Chicago
Information provided by (Responsible Party):
James Dale Lock, Stanford University

April 5, 2012
April 18, 2012
April 13, 2016
September 2011
December 2015   (Final data collection date for primary outcome measure)
Full remission from AN (%MBW>95) [ Time Frame: End of Treatment (6 months) ]
Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
Same as current
Complete list of historical versions of study NCT01579682 on ClinicalTrials.gov Archive Site
Changes in subscale scores of the EDE [ Time Frame: End of Treatment (6 months) ]
Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.
Same as current
Not Provided
Not Provided
Adaptive Family Treatment for Adolescent Anorexia Nervosa
Adaptive Family Treatment for Adolescent Anorexia Nervosa
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.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anorexia Nervosa
  • Behavioral: Family-Based Therapy (FBT)
    12 sessions of FBT over the course of 6 months.
  • Behavioral: 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.
  • Experimental: Psychotherapy
    Family-Based Therapy (12 sessions)
    Intervention: Behavioral: Family-Based Therapy (FBT)
  • Experimental: 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).
    Intervention: Behavioral: Family-Based Therapy with Intensive Family-Focused treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
SPO 49694
SPO 49798 ( Other Grant/Funding Number: NIMH )
Not Provided
Not Provided
James Dale Lock, Stanford University
Stanford University
University of Chicago
Principal Investigator: James D Lock, MD, PhD Stanford University
Principal Investigator: Daniel LeGrange, PhD University of Chicago
Stanford University
April 2016

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