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

University of Louisville (UOFL)

Status: Active, not recruiting

Conditions: Eating Disorders

Treatments: Behavioral: Cognitive Behavioral Therapy for Eating Disorders; Behavioral: Personalized Treatment for Eating Disorders

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05195840

3R34MH128213-01S1 (U.S. NIH Grant/Contract)

IRB#: 21.0689

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Personalized Treatment for Eating Disorders

Experimental group

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.

Treatment:

Behavioral: Personalized Treatment for Eating Disorders

Cognitive Behavioral Therapy for Eating Disorders

Active Comparator group

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Eating Disorders