Treatment for Young Adults With Anorexia Nervosa

NCT ID: NCT01190423

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Family Based therapy for young adults

Group Type EXPERIMENTAL

Family Based Therapy for young adults

Intervention Type BEHAVIORAL

Individual and Group Therapy Sessions

Interventions

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Family Based Therapy for young adults

Individual and Group Therapy Sessions

Intervention Type BEHAVIORAL

Other Intervention Names

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FBT FBT-Y

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eunice Y Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27037965 (View on PubMed)

Related Links

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http://sites.temple.edu/tedp

For More Information About The Study

Other Identifiers

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R34MH083914-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20550

Identifier Type: -

Identifier Source: org_study_id

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