protocolSection identificationModule nctId: NCT06276023, orgStudyIdInfo id: 2023P003638, secondaryIdInfos id: 1R01AG078204-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01AG078204-01, briefTitle: Supporting Our Caregivers In ADRD Learning (SOCIAL), acronym: SOCIAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: National Institute on Aging (NIA), collaborators name: University of California, San Francisco, descriptionModule briefSummary: Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial.Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention., conditionsModule conditions: Alzheimer's Disease and Related Dementias, conditions: Quality of Life, conditions: Caregiver Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: MASC is an intervention that includes evidence-based skills of: 1) mindfulness; 2) compassion toward others and self; 3) behavioral management skills. MASC comprises 6 sessions delivered in a group format over secure live video with Zoom. Each session includes psychoeducation on program skills, skill practice, strategies to incorporate the skill into the caregiver experience, and strategies for sustained practice., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Mindful and Self-Compassionate Care Program (MASC), interventions name: Health Education Program (HEP), outcomesModule primaryOutcomes measure: Feasibility of Recruitment, primaryOutcomes measure: Feasibility of Randomization, primaryOutcomes measure: Feasibility of Assessment Measures, primaryOutcomes measure: Feasibility of Quantitative Measures, primaryOutcomes measure: Adherence to treatment, primaryOutcomes measure: Patient's Global Impression of Change (PGIC), primaryOutcomes measure: Perceptions of Questionnaire Battery, primaryOutcomes measure: Adherence to Home Practice, primaryOutcomes measure: Perceptions of Email and Text Reminders, primaryOutcomes measure: Credibility and Expectancy, primaryOutcomes measure: Modified Perception of Global Improvement, primaryOutcomes measure: Satisfaction with the Intervention, primaryOutcomes measure: Therapist Fidelity, otherOutcomes measure: Symptoms of Depression, otherOutcomes measure: Mindfulness, otherOutcomes measure: Perceived Stress Scale, otherOutcomes measure: Symptoms of Anxiety, otherOutcomes measure: The Self-Compassion Scale, otherOutcomes measure: Compassion, otherOutcomes measure: Caregiver self-efficacy, otherOutcomes measure: Loneliness, otherOutcomes measure: Social Support, otherOutcomes measure: Well-being, otherOutcomes measure: Distress Due to Patient Challenges Behaviors, otherOutcomes measure: Dyadic Relationship Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114-2524, country: United States, contacts name: Michelle StPaul, MS, role: CONTACT, email: mstpaul2@mgh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False