Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-25 @ 4:31 PM
Study NCT ID:
NCT05301257
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly allocated to either control or intervention group. Participants in the control group will receive the same treatment once the intervention group is finished with the treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2022-03-18', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cargiver Burden Inventory (CBI)', 'timeFrame': 'Pre-treatment; Week 8; 12 months post-treatment', 'description': "This measure is used to evaluate caregiver burden. CBI contains 24 questions that are distributed within 5 facets - Time Dependency, Emotional Health, Development, Physical Health and Social Relationships. Answer options are presented on a 5-item Likert scale and ranges from from 0 ('Never') to 4 ('Nearly Always'). Total score on CBI is summed up and ranges from 0 to 96, higher score indicating higher levels of burden experienced."}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale (PSS-10)', 'timeFrame': 'Pre-treatment; Week 8; 12 months post-treatment', 'description': "Measure will be used to evaluate levels of experienced stress. It contains 10 questions on a Likert scale ranging from 0 ('Never') to 4 ('Very Often'). Higher score indicates more severe symptoms."}, {'measure': 'The Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Pre-treatment; Week 8; 12 months post-treatment', 'description': "Measure will be used to evaluate depressive symptoms. It contains 9 questions that must be responded to by choosing an answer from 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms."}, {'measure': 'Generalized Anxiety Disorder (GAD-7)', 'timeFrame': 'Pre-treatment; Week 8; 12 months post-treatment', 'description': "Measure will be used to evaluate caregiver anxiety. GAD-7 contains 7 questions that must be responded to by choosing an answer from 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms."}, {'measure': 'World Health Organization (WHO-5)', 'timeFrame': 'Pre-treatment; Week 8; 12 months post-treatment', 'description': "This questionnaire contains 5 statements regarding individual's well-being. Each of the statements must be evaluated using 6-item Likert scale with a score of 0 indicating 'At no time' while a score of 5 - 'All the time'. Higher score indicates higher well-being."}, {'measure': 'Couple Satisfaction Inventory (CSI-4)', 'timeFrame': 'Pre-treatment; Week 8; 12 months post-treatment', 'description': 'This questionnaire contains 4 statements regarding couple satisfaction. Each of the statements must be evaluated using a 6-item Likert scale. A higher score indicates higher couple satisfaction.'}, {'measure': 'The Inclusion of Illness in the Self Scale (IIS) - Caregiver version', 'timeFrame': 'Pre-treatment; Week 8; 12 months post-treatment', 'description': "This scale included a set of 7 pairs of concentric circles (one labeled 'Self' and one labeled 'Other's Illness') that vary in their degree of overlap from 1 (two separate circles) to 7 (almost completely overlapping circles)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['informal caregiver', 'internet-based intervention', 'caregiver burden', 'culturally adapted', 'eHealth'], 'conditions': ['Caregiver Burden']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Italy in reducing their care-giving burden.', 'detailedDescription': 'This intervention is going to take a form of an Internet-based Intervention (IBI) consisting of eight therapeutic modules. These are the themes, as listed chronologically: Introduction, Thoughts and Acceptance, Problem Solving, Stress and relaxation, Communication, Behavioural Activation, Worry and Anxiety, Maintenance. These themes were chosen after considering topics which might be the most useful for someone in a role of an informal caregiver, considering the trans-diagnostic nature of the intervention.\n\nEffect of the intervention will be compared against a wait-list control group. Intervention is in Italian.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years old or over and both gender;\n2. spent at least the last couple of months providing care;\n3. must have internet access and the ability to use a computer or any other compatible device;\n4. must be able to complete a phone interview -\n\nExclusion Criteria:\n\n1\\) having severe physical or mental impairments, psychiatric conditions or neurological disorders; 2) the person in need of care has a life expectancy below or approximately around 6 months; 3) not able to use a computer or an electronic device; 4) not able to complete a phone interview;\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05301257', 'briefTitle': 'SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.', 'organization': {'class': 'OTHER', 'fullName': 'Bar-Ilan University, Israel'}, 'officialTitle': 'SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.', 'orgStudyIdInfo': {'id': '01122021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group SOSteniamoci', 'description': 'Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden', 'interventionNames': ['Behavioral: Intervention group SOSteniamoci']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group SOSteniamoci', 'description': 'Participants in the control group will be instructed to wait. Once intervention group will be finished, participants in control group will be able to access the same intervention'}], 'interventions': [{'name': 'Intervention group SOSteniamoci', 'type': 'BEHAVIORAL', 'description': "Intervention based on cognitive behavioural therapy principles and culturally adapted to Italian population. Intervention's main purpose is to reduce caregiver burden and increase quality of life. Intervention contains psycho-educational elements as well as examples and exercises.", 'armGroupLabels': ['Experimental Group SOSteniamoci']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20149', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Auxologico Italiano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bar-Ilan University, Israel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Noa Vilchinsky', 'investigatorAffiliation': 'Bar-Ilan University, Israel'}}}}