NCT02852538

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

11.3 years

First QC Date

July 26, 2016

Last Update Submit

May 8, 2026

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    3 months post-treatment

Secondary Outcomes (1)

  • Eating Disorder Examination Total Score

    3 months post-treatment

Study Arms (1)

NEW FED TR for Anorexia

EXPERIMENTAL

NEW FED TR

Behavioral: NEW FED TR

Interventions

NEW FED TRBEHAVIORAL

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).

Also known as: Intensive Temperament Based Treatment
NEW FED TR for Anorexia

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Current diagnosis of anorexia nervosa
  • Illness onset at least 2 years prior to study
  • Medically stable
  • Identified carer to participate in treatment with participant

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California San Diego

San Diego, California, 92121, United States

Location

The Center for Balanced Living

Columbus, Ohio, 43235, United States

Location

Related Publications (3)

  • 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.

    PMID: 26246796BACKGROUND

  • 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.

    PMID: 25377622BACKGROUND

  • 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.

    PMID: 27980771DERIVED

Related Links

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Christina Wierenga, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • Laura Hill, PhD

    The Center for Balanced Living

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 2, 2016

Study Start

February 1, 2015

Primary Completion

May 8, 2026

Study Completion

May 8, 2026

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)