Innovations in Personalizing Treatment Study

NCT ID: NCT06208605

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-21
• Study Completion Date: 2029-02-28

Brief Summary

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.

Conditions

Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Transdiagnostic Network Informed Personalized Treatment

Intervention Type: BEHAVIORAL

Idiographic network analysis is used to determine individuals' top central eating disorder symptoms. Participants then receive modules to address these specific symptoms.

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Cognitive Behavioral Therapy for Eating Disorders

Intervention Type: BEHAVIORAL

Manualized CBT-E (Fairburn 2008) including regular eating, self-monitoring, and CBT modules implemented flexibly.

Interventions

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.

Intervention Type: BEHAVIORAL

Enhanced Cognitive Behavioral Therapy for Eating Disorders

Manualized CBT-E (Fairburn 2008) including regular eating, self-monitoring, and CBT modules implemented flexibly.

Intervention Type: BEHAVIORAL

Other Intervention Names

Personalized Treatment; CBT-E

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Active Suicidality
• Active Mania
• Active psychosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Cheri Levinson

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheri A Levinson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Eating Anxiety Laboratory and Clinic

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cheri A Levinson, PhD

Role: CONTACT

cheri.levinson@louisville.edu

502-852-7795

Jaelin Isquith, B.A.

Role: CONTACT

jaelin.isquith@louisville.edu

502-852-9690

Facility Contacts

Cheri A Levinson, Ph.D.

Role: primary

cheri.levinson@louisville.edu

502-852-7795

References

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.

Reference Type: BACKGROUND

PMID: 36729494 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23537483 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34736538 (View on PubMed)

Other Identifiers

1DP2MH136495-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB#23.0529

Identifier Type: -

Identifier Source: org_study_id