Innovations in Personalizing Treatment Study
- Conditions
- Eating Disorders
- Interventions
- Behavioral: Transdiagnostic Network Informed Personalized TreatmentBehavioral: Enhanced Cognitive Behavioral Therapy for Eating Disorders
- Registration Number
- NCT06208605
- Lead Sponsor
- University of Louisville
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- Current diagnosis of any active eating disorder except ARFID
- Ages 18-65
- Active Suicidality
- Active Mania
- Active psychosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transdiagnostic Network Informed Personalized Treatment 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. Cognitive Behavioral Therapy for Eating Disorders Enhanced 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 Measures
Name Time Method Eating disorder symptoms Up to 18 weeks 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.
Clinical impairment Up to 18 weeks 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.
- Secondary Outcome Measures
Name Time Method Psychological comorbidities using Structured Clinical Interview for DSM-5 (SCID-5) Up to 18 weeks 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.
Medical comorbidities using the Health Utilization and Medical Comorbidities Up to 18 weeks 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.
Health service utilization using the Health Utilization and Medical Comorbidities Up to 18 weeks 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.
Trial Locations
- Locations (1)
Eating Anxiety Laboratory and Clinic
🇺🇸Louisville, Kentucky, United States