Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-26 @ 5:17 PM
Study NCT ID:
NCT05696704
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2023-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth to Reduce Mental Health in Family 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolonged Grief Scale-12 (measuring pre-death grief)', 'timeFrame': '[Time Frame: through study completion, an average of 6 months]', 'description': 'The PG-12 (range 11-55; higher scores mean higher pre-death grief), which is used to measure pre-death grief will be used to measure grief of having a loved one live with a life limiting illness and no longer be able to engage in valued activities.'}], 'secondaryOutcomes': [{'measure': 'Zarit Burden Inventory (ZBI)', 'timeFrame': '[Time Frame: through study completion, an average of 6 months]', 'description': 'Informal caregivers, usually family member, have an increase in burden or feeling they are overwhelmed by their current circumstances. The ZBI is between 0-48, higher scores indicating higher burden.'}, {'measure': 'Perceived Stress Scale', 'timeFrame': '[Time Frame: through study completion, an average of 6 months]', 'description': 'Informal caregivers, usually family members, are unpaid and have a tendency to feel tense and emotionally drained do to caregiving. Scores range from 0-40 with higher scores indicating higher rates of stress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health Issue', 'Grief', 'Burden, Caregiver']}, 'descriptionModule': {'briefSummary': 'The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia when provided over telehealth.', 'detailedDescription': 'Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients over telehealth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia\n* Informal caregivers can be family members or close friends\n* Adults (18 to 89 years old) who read, write, and speak in English\n* Mental Health Diagnosis (e.g., Generalized Anxiety Disorder; Major Depressive Disorder\n\nExclusion Criteria:\n\n* Formal caregivers (who are being paid to take care of the patient)\n* Any informal caregivers with cognitive impairment is identified during the assessment.'}, 'identificationModule': {'nctId': 'NCT05696704', 'briefTitle': 'Telehealth to Reduce Mental Health in Family Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University'}, 'officialTitle': 'Utilizing Telehealth to Reduce Pre-Death Grief, Burden, and Stress in Family Caregivers', 'orgStudyIdInfo': {'id': 'TexasTechU2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness Based Cognitive Therapy', 'description': 'Mindfulness-Based Cognitive Therapy (MBCT) combines the ideas of cognitive therapy with meditative practices and attitudes based on the cultivation of mindfulness. The heart of this work lies in becoming acquainted with the modes of mind that often characterize mood disorders while simultaneously learning to develop a new relationship to them.', 'interventionNames': ['Other: Behavioral: Mindfulness Based Cognitive Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Behavior Activation', 'description': 'BA Increase reinforcing behaviors in order to influence emotions and cognitions.', 'interventionNames': ['Other: Behavioral: Behavior Activation']}], 'interventions': [{'name': 'Behavioral: Mindfulness Based Cognitive Therapy', 'type': 'OTHER', 'otherNames': ['MBCT'], 'description': 'Individual tele-therapy 12 to 16 weeks', 'armGroupLabels': ['Mindfulness Based Cognitive Therapy']}, {'name': 'Behavioral: Behavior Activation', 'type': 'OTHER', 'otherNames': ['BA'], 'description': 'Individual therapy 12 to 16 weeks', 'armGroupLabels': ['Behavior Activation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79382', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan D Singer, Ph.D.', 'role': 'CONTACT', 'email': 'jonsinge@ttu.edu', 'phone': '775-722-8066'}], 'facility': 'Texas Tech University', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}], 'centralContacts': [{'name': 'Casside Street, Ph.D.', 'role': 'CONTACT', 'email': 'casside.street@ttu.edu', 'phone': '(806) 834-2285'}, {'name': 'Keith Jones, Ph.D.', 'role': 'CONTACT', 'email': 'keith.jones@ttu.edu', 'phone': '(806) 834-8745'}], 'overallOfficials': [{'name': 'Jonathan D Singer, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'jonsinge@ttu.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}