Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05920720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-11
First Post:
2023-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-Guided Personalized Treatment for Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disordered eating symptoms', 'timeFrame': 'Up to 8 weeks', 'description': 'Changes in disordered eating symptoms will be assessed with the Eating Disorder Examination Questionnaire-6 (EDE-Q6)'}, {'measure': 'Anxiety', 'timeFrame': 'Up to 8 weeks', 'description': 'Changes in anxiety will be assessed with the Penn State Worry Questionnaire (PSWQ)'}, {'measure': 'Depression', 'timeFrame': 'Up to 8 weeks', 'description': 'Changes in depression will be assessed with the Beck Depression Inventory-2 (BDI-2)'}, {'measure': 'Clinical Impairment', 'timeFrame': 'Up to 8 weeks', 'description': 'Changes in clinical impairment will be assessed with the Clinical Impairment Assessment (CIA)'}, {'measure': 'Quality of life', 'timeFrame': 'Up to 8 weeks', 'description': 'Changes in quality of life will be assessed with the Quality of Life Scale (QOLS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment', 'Therapy', 'Anorexia Nervosa', 'Bulimia Nervosa', 'Binge Eating Disorder', 'Atypical Anorexia Nervosa', 'Other specified feeding and eating disorder'], 'conditions': ['Disordered Eating']}, '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': 'The investigators plan to collect preliminary data on the feasibility, acceptability, and user uptake of a personalized self-guided mobile intervention for disordered eating (DE) and test the initial clinical efficacy of this intervention. Women (N=50) who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones. The investigators will assess engagement with the modules throughout two months and administer baseline, week 5, and week 8 assessments for acceptability, uptake, and initial clinical efficacy (e.g., DE symptoms, anxiety, quality of life). The investigators will also complete a focus group (n=10) with a subset of users to receive input on the mobile-application assessment and ease of self-guided intervention modules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participants will be self-identified women.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endorse disordered eating (score of 2.3 or above on EDE-Q6)\n* Age 18-65\n* Ability to read and write English\n* Own a smartphone or tablet\n\nExclusion Criteria:\n\n* Active mania\n* Active suicidality\n* Active psychosis'}, 'identificationModule': {'nctId': 'NCT05920720', 'briefTitle': 'Self-Guided Personalized Treatment for Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Personalizing Disordered Eating Treatment Using Mobile Technology: Self-Guided, Personalized Treatment for Women', 'orgStudyIdInfo': {'id': 'IRB#23.0274'}, 'secondaryIdInfos': [{'id': '5P20GM103436-23', 'link': 'https://reporter.nih.gov/quickSearch/5P20GM103436-23', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-guided Personalized Treatment', 'description': 'Women who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones.', 'interventionNames': ['Behavioral: Self-guided Personalized Treatment']}], 'interventions': [{'name': 'Self-guided Personalized Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['Personalized Treatment'], 'description': 'Women who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones.', 'armGroupLabels': ['Self-guided Personalized Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40205-1016', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'contacts': [{'name': 'Cheri A Levinson, PhD', 'role': 'CONTACT', 'email': 'cheri.levinson@louisville.edu', 'phone': '502-852-7710'}], 'facility': 'Eating Anxiety Treatment Laboratory and Clinic', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'centralContacts': [{'name': 'Cheri A Levinson, PhD', 'role': 'CONTACT', 'email': 'cheri.levinson@louisville.edu', 'phone': '502-852-7710'}, {'name': 'Abigail K McCarthy, B.S.', 'role': 'CONTACT', 'email': 'abigail.mccarthy.1@louisville.edu'}], 'overallOfficials': [{'name': 'Cheri A Levinson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Cheri Levinson', 'investigatorAffiliation': 'University of Louisville'}}}}