Clinical trial NCT01190423: Treatment for Young Adults With Anorexia Nervosa
Official title: Family-Based Treatment for Weight Restoration in Young Adults With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: AN
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-08-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Weight (BMI)
timeFrame: 6 months of treatment
Secondary outcomes:
measure: Changes in shape and weight concerns as measured with Eating Disorder Examination subscales
timeFrame: 18 therapy sessions or 6 months of treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Eunice Y Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.