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Personalized Treatment for Eating Disorders Versus CBT-E Trial (PT)

Primary Purpose

Eating Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Treatment for Eating Disorders
Cognitive Behavioral Therapy for Eating Disorders
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring eating disorder, treatment, anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia nervosa, therapy, other specified feeding and eating disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65
  • Meets criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
  • Not currently receiving psychological treatment focused on ED

Exclusion Criteria:

  • Under 18
  • Over 65
  • Does not meet criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
  • High and active Suicidality
  • Active Mania
  • Medically Compromised Status including extremely low weight - less than or equal to 75% median BMI for age, sex, and height
  • Simultaneous psychological treatment focused on ED

Sites / Locations

  • Eating Anxiety Treatment Laboratory and ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized Treatment for Eating Disorders

Cognitive Behavioral Therapy for Eating Disorders

Arm Description

Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of personalized treatment for eating disorders.

Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of Cognitive Behavioral Therapy for Eating Disorders.

Outcomes

Primary Outcome Measures

Change in Clinical Impairment using the Clinical Impairment Assessment
The Clinical Impairment Assessment (CIA), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine the severity of psychosocial impairment caused by eating disorders. The scores range from 0 to 64 with higher scores indicating more impairment.
Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire
The Eating Disorder Examination Questionnaire (EDE-Q), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine attitudes and behaviors in individuals with eating disorder symptoms. The scores range from 0-6 with higher scores indicating higher severity of eating disorder symptoms.
Change in Quality of Life using the Quality of Life Scale
The Quality of Life Scale (QOLS), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine various domains of quality of life. Scores range from 16 to 112 with higher scores indicating better quality of life.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2022
Last Updated
May 10, 2023
Sponsor
University of Louisville
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05195840
Brief Title
Personalized Treatment for Eating Disorders Versus CBT-E Trial
Acronym
PT
Official Title
A Pilot Investigation of Network-Informed Personalized Treatment for Eating Disorders Versus Enhanced Cognitive Behavioral Therapy and Dynamic Mechanisms of Change
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: CBT-E). The study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of NA-PT versus CBT-E and (2) to test if network-identified precision targets are the mechanism of change. These goals will ultimately lead to the very first personalized treatment for ED and can be extended to additional psychiatric illnesses. Specific aims are (1) To collect preliminary data on the feasibility and acceptability of the randomization of NA-PT (n=40) for EDs versus CBT-E (n=40), (2) To test the initial clinical efficacy of NA-PT versus CBT-E on clinical outcomes (e.g., ED symptoms, body mass index, quality of life) and (3) To examine if changes in NA-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
eating disorder, treatment, anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia nervosa, therapy, other specified feeding and eating disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Treatment for Eating Disorders
Arm Type
Experimental
Arm Description
Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of personalized treatment for eating disorders.
Arm Title
Cognitive Behavioral Therapy for Eating Disorders
Arm Type
Active Comparator
Arm Description
Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of Cognitive Behavioral Therapy for Eating Disorders.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Treatment for Eating Disorders
Intervention Description
The first three sessions consist of diagnosis and general psychoeducation on EDs and treatment for ED. After mobile-assessment is complete, Session 4 includes psychoeducation on the network-informed model of personalized treatment and 14 sessions (sessions 5-19) are focused on the top three targets (4-5 sessions per target). Session 20 is a termination and conclusion session.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Eating Disorders
Intervention Description
The first three sessions consist of diagnosis and general psychoeducation on EDs and treatment for ED. After mobile-assessment is complete, Session 4 consists of food monitoring, addressing irregular eating, challenging thoughts, making adaptive behavioral changes, and relapse prevention. Session 20 is a termination and conclusion session.
Primary Outcome Measure Information:
Title
Change in Clinical Impairment using the Clinical Impairment Assessment
Description
The Clinical Impairment Assessment (CIA), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine the severity of psychosocial impairment caused by eating disorders. The scores range from 0 to 64 with higher scores indicating more impairment.
Time Frame
Up to 1-Month Follow-Up
Title
Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire
Description
The Eating Disorder Examination Questionnaire (EDE-Q), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine attitudes and behaviors in individuals with eating disorder symptoms. The scores range from 0-6 with higher scores indicating higher severity of eating disorder symptoms.
Time Frame
Up to 1-Month Follow-Up
Title
Change in Quality of Life using the Quality of Life Scale
Description
The Quality of Life Scale (QOLS), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine various domains of quality of life. Scores range from 16 to 112 with higher scores indicating better quality of life.
Time Frame
Up to 1-Month Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 Meets criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN) Not currently receiving psychological treatment focused on ED Exclusion Criteria: Under 18 Over 65 Does not meet criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN) High and active Suicidality Active Mania Medically Compromised Status including extremely low weight - less than or equal to 75% median BMI for age, sex, and height Simultaneous psychological treatment focused on ED
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheri A Levinson, PhD
Phone
502-852-7710
Email
cheri.levinson@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Taylor E Gardner, BA
Email
t0gard02@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheri A Levinson, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eating Anxiety Treatment Laboratory and Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205-1016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheri A Levinson
Phone
502-852-7710
Email
cheri.levinson@louisville.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32918319
Citation
Levinson CA, Williams BM. Eating disorder fear networks: Identification of central eating disorder fears. Int J Eat Disord. 2020 Dec;53(12):1960-1973. doi: 10.1002/eat.23382. Epub 2020 Sep 12.
Results Reference
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PubMed Identifier
30291641
Citation
Levinson CA, Vanzhula I, Brosof LC. Longitudinal and personalized networks of eating disorder cognitions and behaviors: Targets for precision intervention a proof of concept study. Int J Eat Disord. 2018 Nov;51(11):1233-1243. doi: 10.1002/eat.22952. Epub 2018 Oct 6.
Results Reference
background
PubMed Identifier
20599136
Citation
Murphy R, Straebler S, Cooper Z, Fairburn CG. Cognitive behavioral therapy for eating disorders. Psychiatr Clin North Am. 2010 Sep;33(3):611-27. doi: 10.1016/j.psc.2010.04.004.
Results Reference
background
PubMed Identifier
12711261
Citation
Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.
Results Reference
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Personalized Treatment for Eating Disorders Versus CBT-E Trial

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