search
Back to results

Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FBT and CRT
FBT and art therapy
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, Cognitive Remediation Therapy, CRT

Eligibility Criteria

11 Years - 19 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 Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English

Exclusion Criteria:

  • Previous FBT or CRT for AN Medical Instability Medical condition that may affect eating or weight

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FBT and CRT

FBT and art therapy

Arm Description

Family-Based Treatment combined with Cognitive Remediation Therapy (15 sessions of each)

Family-Based Treatment combined with art therapy (15 sessions of each)

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

Full Information

First Posted
January 31, 2014
Last Updated
April 26, 2017
Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT02054364
Brief Title
Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
Official Title
Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be randomly assigned to one of two groups: one group will receive FBT and CRT, and the other group will receive FBT and art therapy.

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, Cognitive Remediation Therapy, CRT

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
FBT and CRT
Arm Type
Experimental
Arm Description
Family-Based Treatment combined with Cognitive Remediation Therapy (15 sessions of each)
Arm Title
FBT and art therapy
Arm Type
Experimental
Arm Description
Family-Based Treatment combined with art therapy (15 sessions of each)
Intervention Type
Behavioral
Intervention Name(s)
FBT and CRT
Other Intervention Name(s)
Family-Based Treatment (FBT) combined with Cognitive Remediation Therapy (CRT)
Intervention Type
Behavioral
Intervention Name(s)
FBT and art therapy
Other Intervention Name(s)
Family-Based Treatment (FBT) combined with art therapy.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 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 Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English Exclusion Criteria: Previous FBT or CRT for AN Medical Instability Medical condition that may affect eating or weight
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Lock, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

Learn more about this trial

Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia

We'll reach out to this number within 24 hrs