NCT00149786

Brief Summary

This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of adolescent anorexia nervosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1

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

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

3.4 years

First QC Date

September 6, 2005

Last Update Submit

April 9, 2012

Conditions

Keywords

Anorexia NervosaAdolescentsFamily therapyIndividual therapy

Outcome Measures

Primary Outcomes (1)

  • Scores on the Eating Disorders Examination

    Measured at Year 1 of treatment and Year 1 of follow-up

Study Arms (2)

1

EXPERIMENTAL

Those adolescents receiving family based therapy

Behavioral: Family Based Therapy

2

ACTIVE COMPARATOR

Those adolescents receiving individual therapy

Behavioral: Ego-Oriented Individual Psychotherapy

Interventions

Family therapy will be given for a total of 24 hours over the course of 12 months.

Also known as: FBT
1

Individual therapy will be given for a total of 24 hours over the course of 12 months.

Also known as: EOIP
2

Eligibility Criteria

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

You may qualify if:

  • Meets DSM-IV criteria for anorexia nervosa
  • Lives with at least one parent who is willing to participate
  • Medically stable
  • Adequate transportation to clinic
  • Proficient at speaking, reading, and writing English

You may not qualify if:

  • Currently undergoing treatment or taking medication that may affect eating or weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago, Pritzker School of Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

  • Le Grange D, Lock J, Accurso EC, Agras WS, Darcy A, Forsberg S, Bryson SW. Relapse from remission at two- to four-year follow-up in two treatments for adolescent anorexia nervosa. J Am Acad Child Adolesc Psychiatry. 2014 Nov;53(11):1162-7. doi: 10.1016/j.jaac.2014.07.014. Epub 2014 Aug 23.

  • Lock J, Le Grange D, Agras WS, Moye A, Bryson SW, Jo B. Randomized clinical trial comparing family-based treatment with adolescent-focused individual therapy for adolescents with anorexia nervosa. Arch Gen Psychiatry. 2010 Oct;67(10):1025-32. doi: 10.1001/archgenpsychiatry.2010.128.

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia Nervosa

Condition Hierarchy (Ancestors)

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

Study Officials

  • James D. Lock, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

October 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2009

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations