Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT05619718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2022-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Loneliness Group Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-05', 'size': 382762, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-12T09:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2022-11-09', 'studyFirstSubmitQcDate': '2022-11-09', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction Questionnaire', 'timeFrame': 'Up to 2 months', 'description': 'Brief open-ended questions about program satisfaction. Responses are qualitative.'}], 'primaryOutcomes': [{'measure': 'Inclusion of Other in the Self Scale (IOS)', 'timeFrame': 'Up to 2 months', 'description': 'Brief single-item pictorial measure of social closeness. The minimum value is 1, the maximum value is 7, and higher scores indicate a better outcome.'}, {'measure': 'UCLA Loneliness Scale (ULS-6)', 'timeFrame': 'Up to 2 months', 'description': 'Brief measure of loneliness. The minimum value is 6, the maximum value is 24, and higher scores indicate a worse outcome.'}, {'measure': 'Relational Health Indices (RHI)', 'timeFrame': 'Up to 2 months', 'description': 'Brief measure of group relational health. The minimum value is 8, the maximum value is 40, and higher scores indicate a better outcome.'}, {'measure': 'Quantitative Program Satisfaction', 'timeFrame': 'Up to 2 months', 'description': 'Brief measure of program satisfaction. The minimum value is 0, the maximum value is 16, and higher scores indicate a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Cantril Self-Anchoring Striving Scale', 'timeFrame': 'Up to 2 months', 'description': '1 item pictorial scale of subjective wellbeing from 0 (minimum) to 10 (maximum). A higher score indicates a better outcome.'}, {'measure': 'Sacred Moment Qualities (SMQ)', 'timeFrame': 'Up to 2 months', 'description': 'Brief measure of perceived sacred qualities, adapted from Pargament et al. (2014). The minimum value is 11, the maximum value is 55, and higher scores indicate a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['loneliness', 'geriatric', 'functional analytic psychotherapy'], 'conditions': ['Loneliness']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot study is to determine the feasibility and acceptability of a group loneliness intervention in geriatric psychiatry inpatients. This type of group loneliness intervention is based on functional analytic psychotherapy and is called Awareness, Courage, and Love Groups.', 'detailedDescription': 'The objective of our clinical trial is to adapt, implement, and evaluate a type of loneliness group intervention called Awareness, Courage, and Love Groups for older adults in a psychiatric unit. The following research questions will be answered: (a) Are ACL groups with geriatric psychiatry inpatients feasible and acceptable? (b) Do such ACL groups demonstrate preliminary efficacy?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to geriatric psychiatry inpatient unit\n\nExclusion Criteria:\n\n* Individuals who are disoriented to person, delirious, unable to tolerate or participate meaningfully in the group, or otherwise unable to provide consent to research and psychotherapy'}, 'identificationModule': {'nctId': 'NCT05619718', 'briefTitle': 'Loneliness Group Intervention', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Loneliness Group Intervention for Geriatric Psychiatry Inpatients', 'orgStudyIdInfo': {'id': '12528'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment group will receive Awareness, Courage, and Love Groups for loneliness.', 'interventionNames': ['Behavioral: Awareness, Courage, and Love Groups']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control group will receive treatment as usual in the form of Mutual Help Meetings.', 'interventionNames': ['Other: Mutual Help Meetings']}], 'interventions': [{'name': 'Awareness, Courage, and Love Groups', 'type': 'BEHAVIORAL', 'description': 'Groups based on the Awareness, Courage, and Love framework from functional analytic psychotherapy', 'armGroupLabels': ['Treatment']}, {'name': 'Mutual Help Meetings', 'type': 'OTHER', 'description': 'Groups based on treatment as usual where patients gather to discuss how they can help others on the ward, and make requests for how others can help them.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6C 0A7', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Parkwood Institute Mental Health', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Elisabeth VanBussel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Joseph's Health Care London"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Western University, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}