Adaptive Family Treatment for Adolescent Anorexia Nervosa

April 12, 2016 updated by: James Dale Lock, Stanford University
Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous FBT for AN
  • Medical condition that may affect eating or weight

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychotherapy
Family-Based Therapy (12 sessions)
Behavioral: Family-Based Therapy (FBT)
12 sessions of FBT over the course of 6 months.
Experimental: Family-Based Therapy with Intensive Family-Focused Treatment
The patient will receive 4 sessions of Family-Based therapy, and if the participant does not make adequate weight gain within this time period, will be assigned to Intensive Family-Focused Therapy (IFT).
Behavioral: Family-Based Therapy with Intensive Family-Focused treatment
FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full remission from AN (%MBW>95)
Time Frame: End of Treatment (6 months)
Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
End of Treatment (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in subscale scores of the EDE
Time Frame: End of Treatment (6 months)
Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.
End of Treatment (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

University of Chicago

Investigators

  • Principal Investigator: James D Lock, MD, PhD, Stanford University
  • Principal Investigator: Daniel LeGrange, PhD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 5, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPO 49694
  • SPO 49798 (Other Grant/Funding Number: NIMH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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