Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06208605
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Innovations in Personalizing Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eating disorder symptoms', 'timeFrame': 'Up to 18 weeks', 'description': '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.'}, {'measure': 'Clinical impairment', 'timeFrame': 'Up to 18 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Psychological comorbidities using Structured Clinical Interview for DSM-5 (SCID-5)', 'timeFrame': 'Up to 18 weeks', 'description': '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.'}, {'measure': 'Medical comorbidities using the Health Utilization and Medical Comorbidities', 'timeFrame': 'Up to 18 weeks', 'description': '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.'}, {'measure': 'Health service utilization using the Health Utilization and Medical Comorbidities', 'timeFrame': 'Up to 18 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eating disorder', 'Treatment', 'Public Health', 'anorexia nervosa', 'bulimia nervosa', 'binge eating disorder', 'Other specified feeding and eating disorder', 'atypical anorexia nervosa'], 'conditions': ['Eating Disorders']}, 'referencesModule': {'references': [{'pmid': '36729494', 'type': 'BACKGROUND', 'citation': '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': '23537483', 'type': 'BACKGROUND', 'citation': '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': '34736538', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current diagnosis of any active eating disorder except ARFID\n* Ages 18-65\n\nExclusion Criteria:\n\n* Active Suicidality\n* Active Mania\n* Active psychosis'}, 'identificationModule': {'nctId': 'NCT06208605', 'acronym': 'T-NIPT-ED', 'briefTitle': 'Innovations in Personalizing Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Innovations in Personalizing Treatment for Eating Disorders Using Idiographic Methods and the Impact of Personalization on Psychological, Physical, and Sociodemographic Outcomes', 'orgStudyIdInfo': {'id': 'IRB#23.0529'}, 'secondaryIdInfos': [{'id': '1DP2MH136495-01', 'link': 'https://reporter.nih.gov/quickSearch/1DP2MH136495-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transdiagnostic Network Informed Personalized Treatment', '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.', 'interventionNames': ['Behavioral: Transdiagnostic Network Informed Personalized Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy for Eating Disorders', '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.', 'interventionNames': ['Behavioral: Enhanced Cognitive Behavioral Therapy for Eating Disorders']}], 'interventions': [{'name': 'Transdiagnostic Network Informed Personalized Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['Personalized Treatment'], 'description': "Idiographic network analysis is used to determine individuals' top central eating disorder symptoms. Participants then receive modules to address these specific symptoms.", 'armGroupLabels': ['Transdiagnostic Network Informed Personalized Treatment']}, {'name': 'Enhanced Cognitive Behavioral Therapy for Eating Disorders', 'type': 'BEHAVIORAL', 'otherNames': ['CBT-E'], 'description': 'Manualized CBT-E (Fairburn 2008) including regular eating, self-monitoring, and CBT modules implemented flexibly.', 'armGroupLabels': ['Cognitive Behavioral Therapy for Eating Disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40205', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cheri A Levinson, Ph.D.', 'role': 'CONTACT', 'email': 'cheri.levinson@louisville.edu', 'phone': '502-852-7795'}], 'facility': 'Eating Anxiety Laboratory and Clinic', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'centralContacts': [{'name': 'Cheri A Levinson, PhD', 'role': 'CONTACT', 'email': 'cheri.levinson@louisville.edu', 'phone': '502-852-7795'}, {'name': 'Jaelin Isquith, B.A.', 'role': 'CONTACT', 'email': 'jaelin.isquith@louisville.edu', 'phone': '502-852-9690'}], 'overallOfficials': [{'name': 'Cheri A Levinson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Cheri Levinson', 'investigatorAffiliation': 'University of Louisville'}}}}