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Treatment for Young Adults With Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT01190423
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : August 26, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: Out-Patient Psychotherapy Treatment Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family-Based Treatment for Weight Restoration in Young Adults With Anorexia Nervosa
Study Start Date : July 2010
Primary Completion Date : April 2016
Study Completion Date : April 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: Family Based Treatment Behavioral: Out-Patient Psychotherapy Treatment
Individual and Group Therapy Sessions
Other Names:
  • FBT
  • FBT-Y

Outcome Measures

Primary Outcome Measures :
  1. Weight (BMI) [ Time Frame: 6 months of treatment ]

Secondary Outcome Measures :
  1. Changes in shape and weight concerns as measured with Eating Disorder Examination subscales [ Time Frame: 18 therapy sessions or 6 months of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190423

United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Temple University
National Institute of Mental Health (NIMH)
Principal Investigator: Eunice Y Chen, PhD Temple University
More Information

Additional Information:
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01190423     History of Changes
Other Study ID Numbers: 20550
R34MH083914-01 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016

Keywords provided by Temple University:

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