NCT01190423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

5.8 years

First QC Date

August 25, 2010

Last Update Submit

April 13, 2018

Conditions

Anorexia Nervosa

Keywords

AN

Outcome Measures

Primary Outcomes (1)

  • Weight (BMI)

    6 months of treatment

Secondary Outcomes (1)

  • Changes in shape and weight concerns as measured with Eating Disorder Examination subscales

    18 therapy sessions or 6 months of treatment

Study Arms (1)

Family Based therapy for young adults

EXPERIMENTAL
Behavioral: Family Based Therapy for young adults

Interventions

Family Based Therapy for young adultsBEHAVIORAL

Individual and Group Therapy Sessions

Also known as: FBT, FBT-Y
Family Based therapy for young adults

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related 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.

    PMID: 27037965RESULT

Related Links

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Eunice Y Chen, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 27, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

US(1)