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NCT Number: NCT06208605

Innovations in Personalizing Treatment Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eating Anxiety Laboratory and Clinic

Louisville, Kentucky, 40205, United States

Location status: Recruiting

Location contact

Cheri A Levinson, Ph.D.

CONTACT

[email protected]

502-852-7795

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Active Suicidality
  • Active Mania
  • Active psychosis

Treatment and study plan

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.

Other names: Personalized Treatment

Enhanced Cognitive Behavioral Therapy for Eating Disorders

Behavioral

Manualized CBT-E (Fairburn 2008) including regular eating, self-monitoring, and CBT modules implemented flexibly.

Other names: CBT-E

Primary outcomes

  1. Eating disorder symptoms

    Time frame: 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.

  2. Clinical impairment

    Time frame: 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 outcomes

  1. Psychological comorbidities using Structured Clinical Interview for DSM-5 (SCID-5)

    Time frame: 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.

  2. Medical comorbidities using the Health Utilization and Medical Comorbidities

    Time frame: 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.

  3. Health service utilization using the Health Utilization and Medical Comorbidities

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheri A Levinson, PhD

CONTACT

[email protected]

502-852-7795

Jaelin Isquith, B.A.

CONTACT

[email protected]

502-852-9690

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: T-NIPT-ED

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jan 17, 2024
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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