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Adaptive Family Treatment for Adolescent Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Based Therapy (FBT)
Family-Based Therapy with Intensive Family-Focused treatment
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Eating Disorder, Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Maudsley, Family-Based Therapy, FBT, Family Therapy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Psychotherapy

Family-Based Therapy with Intensive Family-Focused Treatment

Arm Description

Family-Based Therapy (12 sessions)

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).

Outcomes

Primary Outcome Measures

Full remission from AN (%MBW>95)
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
Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.

Full Information

First Posted
April 5, 2012
Last Updated
April 12, 2016
Sponsor
Stanford University
Collaborators
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01579682
Brief Title
Adaptive Family Treatment for Adolescent Anorexia Nervosa
Official Title
Adaptive Family Treatment for Adolescent Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Eating Disorder, Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Maudsley, Family-Based Therapy, FBT, Family Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychotherapy
Arm Type
Experimental
Arm Description
Family-Based Therapy (12 sessions)
Arm Title
Family-Based Therapy with Intensive Family-Focused Treatment
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Family-Based Therapy (FBT)
Intervention Description
12 sessions of FBT over the course of 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Family-Based Therapy with Intensive Family-Focused treatment
Intervention Description
FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.
Primary Outcome Measure Information:
Title
Full remission from AN (%MBW>95)
Description
Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
Time Frame
End of Treatment (6 months)
Secondary Outcome Measure Information:
Title
Changes in subscale scores of the EDE
Description
Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.
Time Frame
End of Treatment (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Lock, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel LeGrange, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Links:
URL
http://edresearch.stanford.edu
Description
Related information

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Adaptive Family Treatment for Adolescent Anorexia Nervosa

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