Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia

April 26, 2017 updated by: James Dale Lock, Stanford University
This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be randomly assigned to one of two groups: one group will receive FBT and CRT, and the other group will receive FBT and art therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

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

11 years to 19 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 Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English

Exclusion Criteria:

  • Previous FBT or CRT for AN Medical Instability 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: FBT and CRT
Family-Based Treatment combined with Cognitive Remediation Therapy (15 sessions of each)
Behavioral: FBT and CRT
Other Names:
  • Family-Based Treatment (FBT) combined with Cognitive Remediation Therapy (CRT)
Experimental: FBT and art therapy
Family-Based Treatment combined with art therapy (15 sessions of each)
Behavioral: FBT and art therapy
Other Names:
  • Family-Based Treatment (FBT) combined with art therapy.

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)

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

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

November 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34MH101281 (U.S. NIH Grant/Contract)
  • Grant Funding Number (NIH) (Other Grant/Funding Number: SPO#109319)

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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