Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chicago, Illinois 60637


Purpose:

This study will compare specific family therapy, standard family systems therapy, and standard individual psychotherapy to determine which is most effective in treating adolescent anorexia nervosa.


Study summary:

In adolescents, anorexia nervosa severely affects physical, emotional, and social development. Despite the seriousness and prevalence of adolescent anorexia nervosa, few studies have focused on the effectiveness of various types of psychotherapy treatment. Family-based therapy may be an effective approach to treating adolescent anorexia nervosa. This study will compare specific family therapy (FT), standard family systems therapy (FS), and standard individual psychotherapy (IT) to determine which is most effective in treating adolescent anorexia nervosa. The study also aims to determine potential predictors and moderators of outcomes, as well as the cost-benefit ratio of each treatment. Participants in this open-label study will be randomly assigned to one of three treatment groups. Group 1 will receive FT, Group 2 will receive FS, and Group 3 will receive IT. All participants will receive a total of 24 hours of their assigned therapy over a period of 12 months. Study visits will occur at baseline, immediately post-intervention, and again six months and one year post-intervention. Weight change will be assessed, as well as changes in concerns about weight and shape. The cost-benefit ratio of the treatments will also be evaluated.


Criteria:

Inclusion Criteria: - Meets Diagnostic and Statistical Manual (4th Edition) (DSM-IV) criteria for anorexia nervosa Exclusion Criteria: - Any psychotic illness


Study is Available At:


Original ID:

R01MH070620


NCT ID:

NCT00183586


Secondary ID:

R01MH070620


Study Acronym:


Brief Title:

Comparing the Effectiveness of Three Types of Therapy for the Treatment of Anorexia Nervosa in Adolescents


Official Title:

Treatment for Adolescent Anorexia Nervosa


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

121


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel Le Grange, PhD
Principal Investigator
University of Chicago

Study Dates

Start Date:April 2004
Primary Completion Date:March 2009
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 16, 2016
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Changes in shape and weight concerns as measured with Eating Disorder Examination subscales
Time Frame:Measured at end-of-treatment and Months 6 and 12 post-treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Weight (BMI)
Time Frame:Measured at end-of-treatment and Months 6 and 12 post-treatment
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Family therapy (FT)
Description:FT is a family-based treatment that will be given for a total of 24 hours over the course of 12 months.
Arm Name:1
Other Name:FBT
Intervention Type:Behavioral
Name:Individual therapy (IT)
Description:IT is an ego-oriented psychotherapy treatment that will be given for a total of 24 hours over the course of 12 months.
Arm Name:2
Other Name:EOIT or AFT

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Participants will receive individual adolescent focused therapy
Study Arm Type:Experimental
Arm Name:1
Description:Participants will receive family-based treatment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.