Open Trial of Family-Based Treatment for Anorexia Nervosa
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family-Based Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa focused on measuring Adolescents, Anorexia, Eating disorder, Family therapy
Eligibility Criteria
Inclusion Criteria:
- Age 12-17
- Diagnosis of full or subthreshold anorexia nervosa
- At least one parent or guardian willing to participate in treatment
Exclusion Criteria:
- Bipolar Disorder, Psychotic Disorder, Substance Dependence
- Mental Retardation
- Acute suicidal risk
- Acute or unstable, poorly controlled chronic medical illness
- Weight below 75% ideal body weight
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Family therapy
Arm Description
Outcomes
Primary Outcome Measures
weight
Secondary Outcome Measures
Full Information
NCT ID
NCT00417521
First Posted
December 28, 2006
Last Updated
September 25, 2013
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT00417521
Brief Title
Open Trial of Family-Based Treatment for Anorexia Nervosa
Official Title
Pilot Study of Manualized Family Therapy for Adolescents With Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial seeks to investigate the feasibility and effectiveness of delivering a newly manualized family-based treatment for adolescents with anorexia nervosa
Detailed Description
This open trial seeks to investigate the feasibility and effectiveness of delivering a newly manualized family-based treatment for adolescents with anorexia nervosa at a site beyond the treatment's origin. Adolescents ages 12-17 with anorexia nervosa or subthreshold anorexia nervosa were treated with up to one year of this approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Adolescents, Anorexia, Eating disorder, Family therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Family-Based Treatment
Primary Outcome Measure Information:
Title
weight
Time Frame
end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 12-17
Diagnosis of full or subthreshold anorexia nervosa
At least one parent or guardian willing to participate in treatment
Exclusion Criteria:
Bipolar Disorder, Psychotic Disorder, Substance Dependence
Mental Retardation
Acute suicidal risk
Acute or unstable, poorly controlled chronic medical illness
Weight below 75% ideal body weight
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Jones
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Open Trial of Family-Based Treatment for Anorexia Nervosa
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