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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
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Adolescents, Anorexia, Eating disorder, Family therapy

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 28, 2006
    Last Updated
    September 25, 2013
    Sponsor
    New York State Psychiatric Institute
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    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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