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Completed

NCT Number: NCT05195840

Personalized Treatment for Eating Disorders Versus CBT-E Trial

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.

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Key information

Conditions

Eating Disorders Anorexia Nervosa Binge-Eating Disorder Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, 40205-1016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Pilot Investigation of Network-Informed Personalized Treatment for Eating Disorders Versus Enhanced Cognitive Behavioral Therapy and Dynamic Mechanisms of Change

Acronym: PT

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 19, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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