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Treatment for Young Adults With Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Based Therapy for young adults
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring AN

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet DSM-IV criteria for AN (restricting/binge-purge type) (BMI 16.0-18.5)
  • Medically stable for outpatient treatment
  • Availability of at least one supportive adult of choice in study client's environment
  • Stable dose of psychotropic medication (8 weeks) for co-morbid condition

Exclusion Criteria:

  • Associated physical illness that necessitates hospitalization
  • Psychotic illness or other mental illness requiring hospitalization
  • Current dependence on drugs or alcohol
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Previous Family-Based Treatment for Anorexia

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Family Based therapy for young adults

Arm Description

Outcomes

Primary Outcome Measures

Weight (BMI)

Secondary Outcome Measures

Changes in shape and weight concerns as measured with Eating Disorder Examination subscales

Full Information

First Posted
August 25, 2010
Last Updated
April 13, 2018
Sponsor
Temple University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01190423
Brief Title
Treatment for Young Adults With Anorexia Nervosa
Official Title
Family-Based Treatment for Weight Restoration in Young Adults With Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Temple University is conducting a National Institute of Health funded research study designed to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa as well as assess the feasibility of this out-patient psychotherapy.
Detailed Description
Anorexia Nervosa (AN) is a serious psychiatric illness that occurs in an estimated 0.5 to 3.7% of women. The illness severely affects physical, emotional, and social functioning. The mortality rates associated with this severely disabling condition are higher than those for any other psychiatric disorder and substantially higher than those expected in the general population. Lower weight at presentation, longer illness duration, and alcohol abuse are associated with a higher risk of mortality. Treatment-outcome for adult AN is poor with a quarter of adults with AN having poor outcome. In AN, promising outcomes are seen in family-based treatment (FBT) for adolescent patients who present between the ages of 12 to 18 with a short duration of illness. A manualized version of FBT has now been tested in several studies and case series, showing that well over 80% of participants had good or intermediate outcome at post-treatment. Despite its efficacy with adolescents, FBT has not been utilized with young adults. The purpose of this study is to develop and refine FBT to promote weight gain in young adults with Anorexia Nervosa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
AN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Based therapy for young adults
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Family Based Therapy for young adults
Other Intervention Name(s)
FBT, FBT-Y
Intervention Description
Individual and Group Therapy Sessions
Primary Outcome Measure Information:
Title
Weight (BMI)
Time Frame
6 months of treatment
Secondary Outcome Measure Information:
Title
Changes in shape and weight concerns as measured with Eating Disorder Examination subscales
Time Frame
18 therapy sessions or 6 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet DSM-IV criteria for AN (restricting/binge-purge type) (BMI 16.0-18.5) Medically stable for outpatient treatment Availability of at least one supportive adult of choice in study client's environment Stable dose of psychotropic medication (8 weeks) for co-morbid condition Exclusion Criteria: Associated physical illness that necessitates hospitalization Psychotic illness or other mental illness requiring hospitalization Current dependence on drugs or alcohol Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight Previous Family-Based Treatment for Anorexia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eunice Y Chen, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27037965
Citation
Chen EY, Weissman JA, Zeffiro TA, Yiu A, Eneva KT, Arlt JM, Swantek MJ. Family-Based Therapy for Young Adults with Anorexia Nervosa Restores Weight. Int J Eat Disord. 2016 Jul;49(7):701-7. doi: 10.1002/eat.22513. Epub 2016 Apr 1.
Results Reference
result
Links:
URL
http://sites.temple.edu/tedp
Description
For More Information About The Study

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Treatment for Young Adults With Anorexia Nervosa

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