Innovations in Personalizing Treatment Study

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT06208605
Status
Recruiting
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Conditions

  • Eating Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Transdiagnostic Network Informed Personalized Treatment — BEHAVIORAL
    Idiographic network analysis is used to determine individuals' top central eating disorder symptoms. Participants then receive modules to address these specific symptoms.
  • Enhanced Cognitive Behavioral Therapy for Eating Disorders — BEHAVIORAL
    Manualized CBT-E (Fairburn 2008) including regular eating, self-monitoring, and CBT modules implemented flexibly.

Study Details

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.

Key Dates

Start date
Jan 21, 2024
Status verified
Oct 2025
Primary completion
Aug 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Eating disorder symptoms [ Time Frame: Up to 18 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eating Anxiety Laboratory and ClinicLouisvilleKentucky40205
Cheri A Levinson, Ph.D.
[email protected]
502-852-7795

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