NCT00183586

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

4.9 years

First QC Date

September 13, 2005

Last Update Submit

June 16, 2016

Conditions

Eating Disorders

Keywords

Treatment outcomes studyAnorexiaAnorexia nervosa

Outcome Measures

Primary Outcomes (1)

  • Weight (BMI)

    Measured at end-of-treatment and Months 6 and 12 post-treatment

Secondary Outcomes (1)

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

    Measured at end-of-treatment and Months 6 and 12 post-treatment

Study Arms (2)

1

EXPERIMENTAL

Participants will receive family-based treatment

Behavioral: Family therapy (FT)

2

ACTIVE COMPARATOR

Participants will receive individual adolescent focused therapy

Behavioral: Individual therapy (IT)

Interventions

Family therapy (FT)BEHAVIORAL

FT is a family-based treatment that will be given for a total of 24 hours over the course of 12 months.

Also known as: FBT
1
Individual therapy (IT)BEHAVIORAL

IT is an ego-oriented psychotherapy treatment that will be given for a total of 24 hours over the course of 12 months.

Also known as: EOIT or AFT
2

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meets Diagnostic and Statistical Manual (4th Edition) (DSM-IV) criteria for anorexia nervosa

You may not qualify if:

  • Any psychotic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexiaAnorexia Nervosa

Interventions

Family Therapymethylcobalamin-coenzyme M methyltransferase

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Daniel Le Grange, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2004

Primary Completion

March 1, 2009

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

US(1)