NCT06208605 Innovations in Personalizing Treatment Study
| NCT ID | NCT06208605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Louisville |
| Condition | Eating Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2024-01-21 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2024-01-21 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Current diagnosis of any active eating disorder except ARFID * Ages 18-65 Exclusion Criteria: * Active Suicidality * Active Mania * Active psychosis
Contact & Investigator
Cheri A Levinson, PhD
PRINCIPAL INVESTIGATOR
University of Louisville
Frequently Asked Questions
Who can join the NCT06208605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Eating Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06208605 currently recruiting?
Yes, NCT06208605 is actively recruiting participants. Contact the research team at cheri.levinson@louisville.edu for enrollment information.
Where is the NCT06208605 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT06208605 clinical trial?
NCT06208605 is sponsored by University of Louisville. The principal investigator is Cheri A Levinson, PhD at University of Louisville. The trial plans to enroll 320 participants.