Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-09 @ 9:19 AM
Study NCT ID:
NCT04183894
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2019-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-25', 'studyFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2019-11-28', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eating Disorder Symptoms', 'timeFrame': 'Prior to, during, and after personalized intervention through approximately one year.', 'description': 'Changes in eating disorder symptoms will be measured at one month, six month, and 1 year follow-up questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eating disorder', 'network analysis', 'personalized treatment', 'mobile app'], 'conditions': ['Eating Disorders', 'Eating Disorder Symptom']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Beck, J. S. (2011). Cognitive-behavioral therapy. Clinical textbook of addictive disorders, 491, 474-501.'}, {'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': '36729494', 'type': 'DERIVED', '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': '34736538', 'type': 'DERIVED', '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': 'The Personalized Treatment Study creates an individualized network of symptoms for a participant with a current eating disorder. This network will be used to develop a personalized treatment intervention. This study aims to 1) determine if personalized treatments can be conducted using a network analysis of patient symptoms, and 2) to assess the effectiveness of network-informed personalized treatment for participants with eating disorders.', 'detailedDescription': 'Cognitive behavioral theory proposes that cognitions, behaviors, affect, and physiological symptoms interact with each other to maintain and exacerbate psychiatric disorders (Beck, 2011). Network theory identifies core symptoms that maintain and promote the spread of ED psychopathology within individuals (Borsboom \\& Cramer, 2013). Once identified, core "trigger" symptoms can be directly targeted to disrupt the spread or "activation" of ED behaviors, which would help patients achieve full recovery, and ultimately, prevent relapse. One of the main goals of the Personalized Treatment Study is to create an individualized network for a participant with a current eating disorder, which can be used to develop a personalized treatment intervention. Our research questions are: 1) Can a personalized treatment plan be conducted from a network analysis of patient symptoms, and 2) How effective is this personalized treatment based off of a network of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current eating disorder diagnosis\n* at least 18 years of age,\n* not actively suicidal,\n* not manic,\n* not psychotic\n\nExclusion Criteria:\n\n* No current eating disorder diagnosis,\n* younger than 18 years of age,\n* active psychosis,\n* active mania, or\n* actively suicidal.'}, 'identificationModule': {'nctId': 'NCT04183894', 'acronym': 'PT', 'briefTitle': 'Personalized Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Feasibility of Network-Informed Personalized Treatment for Eating Disorders', 'orgStudyIdInfo': {'id': 'IRB# 18.0622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized Intervention Based on Network', 'description': 'Participants will receive personalized interventions based on their personalized network.', 'interventionNames': ['Behavioral: Personalized Intervention']}], 'interventions': [{'name': 'Personalized Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a personalized intervention based on their personalized network.', 'armGroupLabels': ['Personalized Intervention Based on Network']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40292', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Cheri Levinson', 'investigatorAffiliation': 'University of Louisville'}}}}