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Adaptive Family Treatment for Adolescent Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01579682
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : April 13, 2016
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
James Dale Lock, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: Family-Based Therapy (FBT) Behavioral: Family-Based Therapy with Intensive Family-Focused treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptive Family Treatment for Adolescent Anorexia Nervosa
Study Start Date : September 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
Experimental: Psychotherapy
Family-Based Therapy (12 sessions)
 Behavioral: Family-Based Therapy (FBT)
12 sessions of FBT over the course of 6 months.
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).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579682


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Stanford University
University of Chicago
Investigators
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Principal Investigator: James D Lock, MD, PhD Stanford University
Principal Investigator: Daniel LeGrange, PhD University of Chicago
More Information
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Additional Information:

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Responsible Party: James Dale Lock, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01579682    
Other Study ID Numbers: SPO 49694
SPO 49798 ( Other Grant/Funding Number: NIMH )
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Keywords provided by James Dale Lock, Stanford University:
Eating Disorder
Anorexia Nervosa
Eating Disorder Not Otherwise Specified
Maudsley
 Family-Based Therapy
FBT
Family Therapy
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders