Treatment for Young Adults With Anorexia Nervosa

April 13, 2018 updated by: Temple University

Family-Based Treatment for Weight Restoration in Young Adults With Anorexia Nervosa

Temple University is conducting a National Institute of Health funded research study designed to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa as well as assess the feasibility of this out-patient psychotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anorexia Nervosa (AN) is a serious psychiatric illness that occurs in an estimated 0.5 to 3.7% of women. The illness severely affects physical, emotional, and social functioning. The mortality rates associated with this severely disabling condition are higher than those for any other psychiatric disorder and substantially higher than those expected in the general population. Lower weight at presentation, longer illness duration, and alcohol abuse are associated with a higher risk of mortality.

Treatment-outcome for adult AN is poor with a quarter of adults with AN having poor outcome. In AN, promising outcomes are seen in family-based treatment (FBT) for adolescent patients who present between the ages of 12 to 18 with a short duration of illness. A manualized version of FBT has now been tested in several studies and case series, showing that well over 80% of participants had good or intermediate outcome at post-treatment. Despite its efficacy with adolescents, FBT has not been utilized with young adults.

The purpose of this study is to develop and refine FBT to promote weight gain in young adults with Anorexia Nervosa.

Study Type

Interventional

Enrollment (Actual)

22

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Temple 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

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet DSM-IV criteria for AN (restricting/binge-purge type) (BMI 16.0-18.5)
  • Medically stable for outpatient treatment
  • Availability of at least one supportive adult of choice in study client's environment
  • Stable dose of psychotropic medication (8 weeks) for co-morbid condition

Exclusion Criteria:

  • Associated physical illness that necessitates hospitalization
  • Psychotic illness or other mental illness requiring hospitalization
  • Current dependence on drugs or alcohol
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Previous Family-Based Treatment for Anorexia

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Family Based therapy for young adults
Behavioral: Family Based Therapy for young adults
Individual and Group Therapy Sessions
Other Names:
  • FBT
  • FBT-Y

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight (BMI)
Time Frame: 6 months of treatment
6 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in shape and weight concerns as measured with Eating Disorder Examination subscales
Time Frame: 18 therapy sessions or 6 months of treatment
18 therapy sessions or 6 months of treatment

Collaborators and Investigators

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

Sponsor

Temple University

Collaborators

National Institute of Mental Health (NIMH)

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.

General Publications

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

July 1, 2010

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (ESTIMATE)

August 27, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20550
  • R34MH083914-01 (NIH)

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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