Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-10 @ 6:07 PM
Study NCT ID:
NCT03092050
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group Therapy for Depressed Dementia Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019018', 'term': 'Imagery, Psychotherapy'}, {'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were blinded to study hypotheses. Under UCSF IRB #16-20163, on 07.21.2016 (prior to participant enrollment), IRB approval was received for a single-blind study (participant blinding only) due to funding constraints.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 arm randomized controlled trial. During the conduct of the trial, the investigators noted that due to staffing constraints, participant availability, and funding limitations, it would not be feasible to complete a crossover study. This was due to the fact that the investigators were unable to offer crossover group therapy visits at the same time as the initial group sessions. Rather, groups with new participants had to be prioritized and scheduled during the most accessible time slots. Times that the investigators could offer for crossover groups were often inaccessible to participants. Thus, the investigators determined that in the context of this pilot trial, it was not feasible to conduct a full crossover trial due to accessibility. The trial design was therefore updated to parallel (in accordance with the initial funding application).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression symptoms', 'timeFrame': 'approximately 4 weeks post initial group session', 'description': 'Self reported depression symptoms (Quick Inventory of Depression Symptoms)'}], 'secondaryOutcomes': [{'measure': 'Depression symptoms - moderate term', 'timeFrame': 'approximately 3 months post initial group session', 'description': 'Self reported depression symptoms'}, {'measure': 'Depression symptoms - clinician rated', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'Hamilton Depression Rating Scale'}, {'measure': 'Caregiver burden', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'Caregiver Burden Scale self rated questionnaire'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'State Trait Anxiety Inventory - Trait'}, {'measure': 'Mindfulness', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'Five Factor Mindfulness Questionnaire'}, {'measure': 'Positive and Negative Affect', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'Positive and Negative Affect Scale'}, {'measure': 'Well-Being', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'Mental Health Continuum Short Form'}, {'measure': 'Stress', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'Perceived Stress Scale'}, {'measure': 'Resilience', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'Connors Davidson Resilience Scale'}, {'measure': 'Connectedness to Nature', 'timeFrame': 'approximately 4 weeks post initial group session and approximately 3 months post initial group session', 'description': 'Connectedness to Nature Scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': "Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias is a serious public health problem. This is a randomized, controlled, single-blind pilot clinical trial of depressed caregivers, to determine the efficacy and mechanisms of group therapy for depressed dementia caregivers.", 'detailedDescription': 'The trial was designed to measure clinical outcomes including depressive symptoms and other secondary outcomes of caregivers of persons living with dementia. It also included magnetic resonance imagery scanning at baseline (prior to study group) and post group to identify candidate mechanisms of effects.\n\nNotes related to outcome measurement. On 05.10.2017 (prior to participant enrollment), all secondary outcomes were approved by the UCSF IRB #16-20163. It was noted in the IRB that the primary outcome timepoint was to be obtained 4 weeks after the first group session. Due to magnetic resonance imaging scanning scheduling constraints, which occurred at the same time as the 4 weeks visit, the outcome could not be exactly four weeks post the first group session but was collected approximately at this time.\n\nOn 05.10.2017 (prior to participant enrollment), three-month post group secondary outcomes were also approved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEndorse clinically relevant baseline depressive symptoms Primary caregiver for a relative with dementia\n\nExclusion Criteria:\n\nAge \\< 45 Meditation / guided imagery practice more than twice per week Ideas of harming relative with dementia Current violence towards relative with dementia Adult Protective Services report on file Primary psychiatric disorder other than unipolar major depression Cognitive impairment on the part of the caregiver (Mini Mental State Examination score less than 24) Unstable medical illness Planned surgery Active drug or alcohol abuse Inability to understand written and oral English.'}, 'identificationModule': {'nctId': 'NCT03092050', 'briefTitle': 'Group Therapy for Depressed Dementia Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': "Group Therapy for Depressed Caregivers of Alzheimer's Disorder and Related Dementias", 'orgStudyIdInfo': {'id': 'MIT001'}, 'secondaryIdInfos': [{'id': 'R21AG051970', 'link': 'https://reporter.nih.gov/quickSearch/R21AG051970', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Facilitated Discussion', 'description': 'Weekly facilitated discussion for 4 weeks', 'interventionNames': ['Behavioral: Facilitated Discussion']}, {'type': 'EXPERIMENTAL', 'label': 'Guided Imagery and mindfulness', 'description': 'Weekly guided imagery and mindfulness for 4 weeks', 'interventionNames': ['Behavioral: Guided Imagery and Mindfulness']}], 'interventions': [{'name': 'Guided Imagery and Mindfulness', 'type': 'BEHAVIORAL', 'description': 'This is a behavioral intervention using guided imagery and mindfulness techniques.', 'armGroupLabels': ['Guided Imagery and mindfulness']}, {'name': 'Facilitated Discussion', 'type': 'BEHAVIORAL', 'description': 'This is a behavioral intervention that involves discussion and group support.', 'armGroupLabels': ['Facilitated Discussion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Felipe Jain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychiatrist', 'investigatorFullName': 'Felipe A Jain', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}