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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02852538
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : April 28, 2021
National Eating Disorders 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2015
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arm Intervention/treatment
Experimental: NEW FED TR for Anorexia
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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)

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 identifier (NCT number): NCT02852538

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Contact: Amber Scott 614.896.8215

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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   
Sub-Investigator: Laura Hill, PhD         
Sponsors and Collaborators
University of California, San Diego
National Eating Disorders Association
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Principal Investigator: Christina Wierenga, PhD University of California, San Diego
Study Chair: Laura Hill, PhD The Center for Balanced Living
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Christina Wierenga, Associate Professor, University of California, San Diego Identifier: NCT02852538    
Other Study ID Numbers: 110659
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders