We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT05195840
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : April 15, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Cheri Levinson, University of Louisville

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: Personalized Treatment for Eating Disorders Behavioral: Cognitive Behavioral Therapy for Eating Disorders Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Investigation of Network-Informed Personalized Treatment for Eating Disorders Versus Enhanced Cognitive Behavioral Therapy and Dynamic Mechanisms of Change
Actual Study Start Date : April 6, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : November 30, 2024
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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 personalized treatment for eating disorders.
 Behavioral: Personalized Treatment for Eating Disorders
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.
Active Comparator: Cognitive Behavioral Therapy 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.
 Behavioral: Cognitive Behavioral Therapy for Eating Disorders
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Clinical Impairment using the Clinical Impairment Assessment [ Time Frame: Up to 1-Month Follow-Up ]
    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.

  2. Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire [ Time Frame: Up to 1-Month Follow-Up ]
    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.

  3. Change in Quality of Life using the Quality of Life Scale [ Time Frame: Up to 1-Month Follow-Up ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05195840


Contacts
Layout table for location contacts
Contact: Cheri A Levinson, PhD 502-852-7710 cheri.levinson@louisville.edu
Contact: Taylor E Gardner, BA t0gard02@louisville.edu

Locations
Layout table for location information
United States, Kentucky
Eating Anxiety Treatment Laboratory and Clinic Recruiting
Louisville, Kentucky, United States, 40205-1016
Contact: Cheri A Levinson    502-852-7710    cheri.levinson@louisville.edu   
Sponsors and Collaborators
University of Louisville
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Cheri A Levinson, PhD University of Louisville
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Cheri Levinson, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT05195840    
Other Study ID Numbers: IRB#: 21.0689
1R34MH128213-01 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheri Levinson, University of Louisville:
eating disorder
treatment
anorexia nervosa
bulimia nervosa
 binge eating disorder
atypical anorexia nervosa
therapy
other specified feeding and eating disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders