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

University of Louisville (UOFL)

Status: Enrolling

Conditions: Eating Disorders

Treatments: Behavioral: Enhanced Cognitive Behavioral Therapy for Eating Disorders; Behavioral: Transdiagnostic Network Informed Personalized Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06208605

1DP2MH136495-01 (U.S. NIH Grant/Contract)

IRB#23.0529

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Active Suicidality
• Active Mania
• Active psychosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Transdiagnostic Network Informed Personalized Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Transdiagnostic Network Informed Personalized Treatment

Cognitive Behavioral Therapy for Eating Disorders

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Cognitive Behavioral Therapy for Eating Disorders