Innovations in Personalizing Treatment Study (T-NIPT-ED)

Innovations in Personalizing Treatment for Eating Disorders Using Idiographic Methods and the Impact of Personalization on Psychological, Physical, and Sociodemographic Outcomes

Eating disorders (EDs) are serious mental illness: someone dies of an ED every 52 minutes. EDs are highly related to a host of negative outcomes, including public health and individual disease burden, medical and psychological comorbidities, and social determinants of health (SDOH). Treatment response for EDs are suboptimal; there are no evidence-based treatment for adults with anorexia nervosa (AN) or Other Specified Feeding or Eating Disorder (OSFED) and only 50% of adults respond to current evidence based treatments. There are no precision treatments, nor any treatments that consider social context, in existence. Personalized treatments for EDs, that consider social contexts, are urgently needed to improve treatment response and minimize the suffering associated with these illnesses. The investigators' overall goal, extending upon their past work, is to create a treatment personalized based on idiographic (or one person) models (termed Transdiagnostic Network Informed Personalized Treatment for EDs; T-NIPT-ED). The investigators will carry out a two-phase study to systematically characterize individual mechanisms of treatment (Phase I: N=900) and then test the efficacy of each treatment module (Phase II: N=240 drawn from Phase I) compared to the current gold-standard treatment (Cognitive Behavioral Therapy Enhanced: CBT-E). The study goals are to (1) characterize the prevalence of T-NIPT-ED precision treatment mechanisms and medical and psychological comorbidities (e.g., obesity; depression), individual disease burden (e.g., disability), SDOH (e.g., food insecurity), and public health outcomes (e.g., service utilization) specific to these mechanisms, (2) identify if personalized target mechanisms improve when matched to evidence-based treatment modules of T-NIPT-ED and (3) test if change in T-NIPT-ED is associated with improved outcomes (vs CBT-E), including ED outcomes, comorbidities, disease burden, and public health outcomes and if these outcomes are moderated by SDOH. These goals will ultimately lead to the very first precision treatment for ED and can be extended to additional psychiatric illnesses. The proposed research uses highly innovative methods; intensive longitudinal data collected with mobile technology is combined with state-of-the art idiographic modeling methods to deliver a virtual, personalized treatment. This proposal integrates assessment of broad (e.g., SDOH; public health burden) and specific (e.g., ED symptoms) outcomes, to ensure that social context can be integrated into personalization. The proposed research has high clinical impact. Ultimately, this proposal will lead directly to the creation and dissemination of an evidence-based individually-personalized treatment for EDs, as well as will serve as an exemplar for precision treatment development across the entire field of psychiatry.

Study Overview

• Status: Recruiting
• Conditions: Eating Disorders
• Intervention / Treatment: Behavioral: Transdiagnostic Network Informed Personalized Treatment; Behavioral: Enhanced Cognitive Behavioral Therapy for Eating Disorders

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheri A Levinson, PhD; Phone Number: 502-852-7795; Email: cheri.levinson@louisville.edu
• Study Contact Backup: Name: Jaelin Isquith, B.A.; Phone Number: 502-852-9690; Email: jaelin.isquith@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Recruiting
      • Eating Anxiety Laboratory and Clinic
      • Contact: Cheri A Levinson, Ph.D.; Phone Number: 502-852-7795; Email: cheri.levinson@louisville.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current diagnosis of any active eating disorder except ARFID
• Ages 18-65

Exclusion Criteria:

• Active Suicidality
• Active Mania
• Active psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdiagnostic Network Informed Personalized Treatment; Participants will receive 1 session of education about the treatment after completing Phase I of the study (two weeks of ecological momentary assessment). Participants will then complete 10 sessions of personalized treatment for eating disorders based on their ecological momentary assessment surveys. Participants will complete one session of relapse prevention at the end.	Behavioral: Transdiagnostic Network Informed Personalized Treatment; Idiographic network analysis is used to determine individuals' top central eating disorder symptoms. Participants then receive modules to address these specific symptoms.; Other Names: Personalized Treatment
Active Comparator: Cognitive Behavioral Therapy for Eating Disorders; Participants will receive 1 session of education about the treatment after completing Phase I of the study (two weeks of ecological momentary assessment). Participants will then complete 10 sessions of Enhanced Cognitive Behavioral Therapy for Eating Disorders (CBT-E. Participants will complete one session of relapse prevention at the end.	Behavioral: Enhanced Cognitive Behavioral Therapy for Eating Disorders; Manualized CBT-E (Fairburn 2008) including regular eating, self-monitoring, and CBT modules implemented flexibly.; Other Names: CBT-E

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating disorder symptoms	Eating Disorder Examination Questionnaire 6.0 (EDE-Q) will be used to measure change in eating disorder symptoms. The EDEQ has a minimum global score of 0 and a maximum global score of 132. Higher scores indicate more severe eating pathology.	Up to 18 weeks
Clinical impairment	The Clinical Impairment Assessment (CIA) will be used to measure change in severity of psychosocial impairment. The CIA has a minimum score of 0 and a maximum score of 48, with higher scores indicating higher levels of impairment.	Up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological comorbidities using Structured Clinical Interview for DSM-5 (SCID-5)	The investigators will be assessing psychological comorbidities using the SCID-5. The SCID-5 is a semi-structured interview used to arrive at DSM-5 diagnoses. Participants will complete the ED, anxiety, depression, mania, psychosis, and suicide modules.	Up to 18 weeks
Medical comorbidities using the Health Utilization and Medical Comorbidities	The investigators will measure medical comorbidities (e.g., obesity) using the Health Utilization and Medical Comorbidities measure. This measure does not have a score but rather asks questions about different types of healthcare services and medical conditions and whether the participant has/has used them.	Up to 18 weeks
Health service utilization using the Health Utilization and Medical Comorbidities	The investigators will measure health service utilization using the Health Utilization and Medical Comorbidities measure. This measure does not have a score but rather asks questions about different types of healthcare services and medical conditions and whether the participant has/has used them.	Up to 18 weeks

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Cheri A Levinson, PhD, University of Louisville

Publications and helpful links

General Publications

• Borsboom D, Cramer AO. Network analysis: an integrative approach to the structure of psychopathology. Annu Rev Clin Psychol. 2013;9:91-121. doi: 10.1146/annurev-clinpsy-050212-185608.
• Levinson CA, Williams BM, Christian C, Hunt RA, Keshishian AC, Brosof LC, Vanzhula IA, Davis GG, Brown ML, Bridges-Curry Z, Sandoval-Araujo LE, Ralph-Nearman C. Personalizing eating disorder treatment using idiographic models: An open series trial. J Consult Clin Psychol. 2023 Jan;91(1):14-28. doi: 10.1037/ccp0000785.
• Levinson CA, Hunt RA, Keshishian AC, Brown ML, Vanzhula I, Christian C, Brosof LC, Williams BM. Using individual networks to identify treatment targets for eating disorder treatment: a proof-of-concept study and initial data. J Eat Disord. 2021 Nov 4;9(1):147. doi: 10.1186/s40337-021-00504-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 6, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Treatment; anorexia nervosa; Public Health; Eating disorder; bulimia nervosa; binge eating disorder; atypical anorexia nervosa; Other specified feeding and eating disorder
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Binge-Eating Disorder; Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa
• Other Study ID Numbers: IRB#23.0529; 1DP2MH136495-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No