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

Primary Purpose

Anorexia Nervosa

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEW FED TR
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of California San Diego
  • The Center for Balanced Living

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEW FED TR for Anorexia

Arm Description

NEW FED TR

Outcomes

Primary Outcome Measures

Body Mass Index

Secondary Outcome Measures

Eating Disorder Examination Total Score
Clinical symptoms

Full Information

First Posted
July 26, 2016
Last Updated
June 6, 2023
Sponsor
University of California, San Diego
Collaborators
National Eating Disorders Association
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1. Study Identification

Unique Protocol Identification Number
NCT02852538
Brief Title
Outcomes of a Skill-Based Program for Eating Disorders
Acronym
NEW FED TR
Official Title
An Innovative Family Based Treatment for Adults With Anorexia Nervosa Using Insights From Neurobiology
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Eating Disorders Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NEW FED TR for Anorexia
Arm Type
Experimental
Arm Description
NEW FED TR
Intervention Type
Behavioral
Intervention Name(s)
NEW FED TR
Other Intervention Name(s)
Intensive Temperament Based Treatment
Intervention Description
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).
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
3 months post-treatment
Secondary Outcome Measure Information:
Title
Eating Disorder Examination Total Score
Description
Clinical symptoms
Time Frame
3 months post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Wierenga, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Hill, PhD
Organizational Affiliation
The Center for Balanced Living
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
The Center for Balanced Living
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26246796
Citation
Knatz S, Wierenga CE, Murray SB, Hill L, Kaye WH. Neurobiologically informed treatment for adults with anorexia nervosa: a novel approach to a chronic disorder. Dialogues Clin Neurosci. 2015 Jun;17(2):229-36. doi: 10.31887/DCNS.2015.17.2/sknatz.
Results Reference
background
PubMed Identifier
25377622
Citation
Kaye WH, Wierenga CE, Knatz S, Liang J, Boutelle K, Hill L, Eisler I. Temperament-based treatment for anorexia nervosa. Eur Eat Disord Rev. 2015 Jan;23(1):12-8. doi: 10.1002/erv.2330. Epub 2014 Nov 6.
Results Reference
background
PubMed Identifier
27980771
Citation
Hill L, Peck SK, Wierenga CE, Kaye WH. Applying neurobiology to the treatment of adults with anorexia nervosa. J Eat Disord. 2016 Dec 5;4:31. doi: 10.1186/s40337-016-0119-x. eCollection 2016.
Results Reference
derived
Links:
URL
http://eatingdisorders.ucsd.edu
Description
UCSD Eating Disorder Treatment and Research Program

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Outcomes of a Skill-Based Program for Eating Disorders

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