Treatment for Young Adults With Anorexia Nervosa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Temple University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01190423
First received: August 25, 2010
Last updated: March 26, 2013
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Anorexia Nervosa
Behavioral: Out-Patient Psychotherapy Treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family-Based Treatment for Weight Restoration in Young Adults With Anorexia Nervosa

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Weight (BMI) [ Time Frame: 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in shape and weight concerns as measured with Eating Disorder Examination subscales [ Time Frame: 18 therapy sessions or 6 months of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Based Treatment Behavioral: Out-Patient Psychotherapy Treatment
Individual and Group Therapy Sessions
Other Names:
  • FBT
  • FBT-Y

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190423

Contacts
Contact: Eunice Y Chen, PhD (215) 204-2645 eunice.chen@temple.edu

Locations
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Eunice Y Chen, PhD    215-204-2645    eunice.chen@temple.edu   
Principal Investigator: Eunice Y Chen, PhD         
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Eunice Y Chen, PhD Temple University
  More Information

Additional Information:
No publications provided

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01190423     History of Changes
Other Study ID Numbers: 20550, R34MH083914-01
Study First Received: August 25, 2010
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
AN

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014