Treatment for Young Adults With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190423
• Other study ID #: 20550
• Secondary ID: R34MH083914-01
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: April 13, 2018
• Start date: July 2010
• Est. completion date: April 2016

Study information

• Verified date: April 2018
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• Family Based Therapy for young adults
Individual and Group Therapy Sessions

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen EY, Weissman JA, Zeffiro TA, Yiu A, Eneva KT, Arlt JM, Swantek MJ. Family-Based Therapy for Young Adults with Anorexia Nervosa Restores Weight. Int J Eat Disord. 2016 Jul;49(7):701-7. doi: 10.1002/eat.22513. Epub 2016 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (BMI)		6 months of treatment
Secondary	Changes in shape and weight concerns as measured with Eating Disorder Examination subscales		18 therapy sessions or 6 months of treatment

External Links

•   For More Information About The Study