Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT05334992
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2022-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Mental Health in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099025', 'term': 'Mindfulness-Based Cognitive Therapy'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Mindfulness Based Cognitive Therapy; Behavior Activation; Group Therapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolonged Grief Scale-12 (measuring pre-death grief)', 'timeFrame': '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 activites.'}], 'secondaryOutcomes': [{'measure': 'Zarit Burden Inventory (ZBI)', 'timeFrame': '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': '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', 'detailedDescription': 'Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients.\n\nAim 2: Examine the effects of a modified evidence-based group therapy for informal caregivers of dementia patients.'}, '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': 'NCT05334992', 'briefTitle': 'Reducing Mental Health in Informal Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University'}, 'officialTitle': 'Reducing Pre-Death Grief, Burden, and Stress in Informal Caregivers: A Group and Individual Therapy Approach', 'orgStudyIdInfo': {'id': 'TexasTechU'}, 'secondaryIdInfos': [{'id': 'tech', 'type': 'OTHER', 'domain': 'TexasTechU'}]}, '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': ['Behavioral: Mindfulness Based Cognitive Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Behavior Activation', 'description': 'BA Increase reinforcing behaviors in order to influence emotions and cognitions.', 'interventionNames': ['Behavioral: Behavior Activation']}], 'interventions': [{'name': 'Mindfulness Based Cognitive Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['MBCT'], 'description': 'Individual therapy 12 to 16 weeks', 'armGroupLabels': ['Mindfulness Based Cognitive Therapy']}, {'name': 'Behavior Activation', 'type': 'BEHAVIORAL', '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, PhD', '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'}}}}