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

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ClinicalTrials.gov Identifier: NCT02852538
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
National Eating Disorder Association
Information provided by (Responsible Party):
Christina Wierenga, University of California, San Diego

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
Anorexia Nervosa Behavioral: NEW FED TR Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 : February 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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 Name: Intensive Temperament Based Treatment




Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: 3 months post-treatment ]

Secondary Outcome Measures :
  1. Eating Disorder Examination Total Score [ Time Frame: 3 months post-treatment ]
    Clinical symptoms



Information from the National Library of Medicine

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852538


Contacts
Contact: Amber Scott 614.896.8215 amber.scott@thecenterforbalancedliving.org

Locations
United States, California
University of California San Diego Active, not recruiting
San Diego, California, United States, 92121
United States, Ohio
The Center for Balanced Living Recruiting
Columbus, Ohio, United States, 43235
Contact: Amber Scott    614-896-8215    amber.scott@thecenterforbalancedliving.org   
Sub-Investigator: Laura Hill, PhD         
Sponsors and Collaborators
University of California, San Diego
National Eating Disorder Association
Investigators
Principal Investigator: Christina Wierenga, PhD University of California, San Diego
Study Chair: Laura Hill, PhD The Center for Balanced Living

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christina Wierenga, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02852538     History of Changes
Other Study ID Numbers: 110659
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders