Personalized Treatment for Eating Disorders Versus CBT-E Trial

NCT05195840 | Completed DMC

• 2 other identifiers: IRB#: 21.06893R34MH128213-01S1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders

Keywords

eating disorder; treatment; anorexia nervosa; bulimia nervosa; binge eating disorder; atypical anorexia nervosa; therapy; other specified feeding and eating disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 1-Month Follow-Up

• 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.

  Up to 1-Month Follow-Up

• 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.

  Up to 1-Month Follow-Up

Study Arms (2)

Personalized Treatment for Eating Disorders

EXPERIMENTAL

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

Cognitive Behavioral Therapy for Eating Disorders

ACTIVE COMPARATOR

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

Interventions

Personalized Treatment for Eating Disorders BEHAVIORAL

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.

Personalized Treatment for Eating Disorders

Cognitive Behavioral Therapy for Eating Disorders BEHAVIORAL

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.

Cognitive Behavioral Therapy for Eating Disorders

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, 40205-1016, United States

Location

Related Publications (4)

• 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.

  PMID: 32918319 BACKGROUND

• 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.

  PMID: 30291641 BACKGROUND

• 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.

  PMID: 20599136 BACKGROUND

• 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.

  PMID: 12711261 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cheri A Levinson, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 19, 2022
• Study Start: April 6, 2022
• Primary Completion: November 30, 2025
• Study Completion: January 29, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)