Adaptive Family Treatment for Adolescent Anorexia Nervosa

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Chicago
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01579682
First received: April 5, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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 Intervention
Anorexia Nervosa
Behavioral: Family-Based Therapy (FBT)
Behavioral: Family-Based Therapy with Intensive Family-Focused treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Family Treatment for Adolescent Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Full remission from AN (%MBW>95) [ Time Frame: End of Treatment (6 months) ] [ Designated as safety issue: No ]
    Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)


Secondary Outcome Measures:
  • Changes in subscale scores of the EDE [ Time Frame: End of Treatment (6 months) ] [ Designated as safety issue: No ]
    Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.


Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579682

Locations
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
Principal Investigator: James D Lock, MD, PhD Stanford University
Principal Investigator: Daniel LeGrange, PhD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01579682     History of Changes
Other Study ID Numbers: SPO 49694, SPO 49798
Study First Received: April 5, 2012
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Eating Disorder
Anorexia Nervosa
Eating Disorder Not Otherwise Specified
Maudsley
Family-Based Therapy
FBT
Family Therapy

Additional relevant MeSH terms:
Anorexia Nervosa
Anorexia
Eating Disorders
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014