Innovations in Personalizing Treatment Study

Official title

Innovations in Personalizing Treatment for Eating Disorders Using Idiographic Methods and the Impact of Personalization on Psychological, Physical, and Sociodemographic Outcomes

Overview

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.

Interventions

• Behavioral 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.
• Behavioral Enhanced Cognitive Behavioral Therapy for Eating Disorders
  Manualized CBT-E (Fairburn 2008) including regular eating, self-monitoring, and CBT modules implemented flexibly.

Primary outcome measures

• Eating disorder symptoms [Time frame: Up to 18 weeks]
• Clinical impairment [Time frame: Up to 18 weeks]

Secondary outcome measures (3)

• Psychological comorbidities using Structured Clinical Interview for DSM-5 (SCID-5) [Time frame: Up to 18 weeks]
• Medical comorbidities using the Health Utilization and Medical Comorbidities [Time frame: Up to 18 weeks]
• Health service utilization using the Health Utilization and Medical Comorbidities [Time frame: Up to 18 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Active Suicidality
• Active Mania
• Active psychosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Eating Anxiety Laboratory and Clinic — Louisville

Publications

• 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. PMID 36729494
• 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. PMID 23537483
• 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. PMID 34736538

Identifiers

NCT: NCT06208605 · IRB#23.0529 · 1DP2MH136495-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗