Personalized Treatment for Eating Disorders Versus CBT-E Trial

Not Applicable

Active, not recruiting

• Conditions: Eating Disorders
• Interventions: Behavioral: Cognitive Behavioral Therapy for Eating Disorders; Behavioral: Personalized Treatment for Eating Disorders

• Registration Number: NCT05195840
• Lead Sponsor: University of Louisville

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Study Start: 2022-04-06
• Primary Completion: 2024-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy for Eating Disorders	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.
Personalized Treatment for Eating Disorders	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.

Primary Outcome Measures

Name	Time	Method
Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire	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.
Change in Quality of Life using the Quality of Life Scale	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.
Change in Clinical Impairment using the Clinical Impairment Assessment	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.

Trial Locations

Locations (1)

Eating Anxiety Treatment Laboratory and Clinic; 🇺🇸 Louisville, Kentucky, United States