Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 17, 2014
Last verified: November 2014

April 5, 2012
November 17, 2014
September 2011
September 2015   (final data collection date for primary outcome measure)
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)
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) ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
90
September 2015
September 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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01579682
SPO 49694, SPO 49798
Yes
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
November 2014

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