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NEW FED TR: Outcomes of a Skill-Based Program for Eating Disorders

Sponsor
University of California, San Diego (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02852538
Collaborator
National Eating Disorders Association (Other)
200
Enrollment
2
Locations
1
Arm
143
Duration (Months)
100
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to measure the effect of a neurobiologically-guided intensive family based treatment for adults with anorexia nervosa.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NEW FED TR
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Innovative Family Based Treatment for Adults With Anorexia Nervosa Using Insights From Neurobiology
Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: NEW FED TR for Anorexia

NEW FED TR

Behavioral: NEW FED TR
NEW FED TR is a five day treatment for adults with anorexia nervosa. It is a neurobiologically informed, interactive, family-based treatment that draws upon the specific etiological traits characterizing anorexia nervosa. It stands for Neurobiological research findings Enhanced With Family/Friends of those with Eating Disorders, addressing Trait Responses that both create a vulnerability to the illness and serve as markers for recovery through treatment (formerly reported as Temperament-Based Treatment).
Other Names:
  • Intensive Temperament Based Treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Body Mass Index [3 months post-treatment]

    Secondary Outcome Measures

    1. Eating Disorder Examination Total Score [3 months post-treatment]

      Clinical symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Current diagnosis of anorexia nervosa

    • Illness onset at least 2 years prior to study

    • Medically stable

    • Identified carer to participate in treatment with participant

    Exclusion Criteria:

    • Developmental or intellectual disorder

    • Diagnosis of substance abuse or dependence in 3 months prior to study

    • Current suicidal thoughts

    • Severe comorbid psychiatric disorder (e.g., psychotic disorder, bipolar disorder)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Diego San Diego California United States 92121
    2 The Center for Balanced Living Columbus Ohio United States 43235

    Sponsors and Collaborators

    • University of California, San Diego
    • National Eating Disorders Association

    Investigators

    • Principal Investigator: Christina Wierenga, PhD, University of California, San Diego
    • Study Chair: Laura Hill, PhD, The Center for Balanced Living

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Christina Wierenga, Associate Professor, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT02852538
    Other Study ID Numbers:
    • 110659
    First Posted:
    Aug 2, 2016
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Anorexia
    Anorexia Nervosa

    Study Results

    No Results Posted as of May 26, 2022