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Intervention for the Management of Neuropsychiatric Symptoms to Reduce Caregiver Stress: Protocol for the Mindful and Self-Compassion Care Intervention for Caregivers of Persons Living With Dementia.

JMIR research protocols
January 1, 1970
Aniyah Travis et al. (8 authors)
Clinical StudyJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to develop and evaluate the Mindful and Self-Compassionate Care (MASC) program, which combines mindfulness and self-compassion with behavioral management skills to reduce caregiver stress in individuals caring for persons with Alzheimer disease and related dementias (ADRD).

Results Summary

Caregivers expressed interest in a brief, online stress management program and found mindfulness and self-compassion skills helpful when linked to caregiving routines. Phases 2 and 3, which will assess feasibility and preliminary efficacy, are set to be completed by the end of 2025.

Population

Stressed caregivers of persons with ADRD and challenging behaviors.

Effective Dosage

Not specified

Duration

6 weeks

Interactions

None mentioned

Extracted Claims (2)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Mindfulness and self-compassion programs
decrease
managing stress
-
-
are efficacious for
#1
Mindful and Self-Compassionate Care (MASC) program
decrease
caregiver stress
stressed individuals caring for persons with ADRD and challenging behaviors
-
to decrease
#2
Abstract

BACKGROUND: Stress related to Alzheimer disease and related dementias (ADRD) is common, particularly among those who care for persons with challenging behaviors and personality or mood changes. Mindfulness and self-compassion programs are efficacious for managing stress. The skills of mindfulness and self-compassion, however, must be integrated with behavioral management skills in order to effectively improve caregiver stress. OBJECTIVE: In this study, we aimed to describe the development of the Mindful and Self-Compassionate Care (MASC) program, the first program that combines mindfulness and self-compassion with behavioral management skills to decrease caregiver stress, and its evaluation in the Supporting Our Caregivers in ADRD Learning (SOCIAL) study. METHODS: Using the National Institutes of Health (NIH) stage model, we describe 3 phases of work encompassing NIH Stages 1A and 1B. In phase 1, we conducted 5 focus groups (N=28) of stressed individuals caring for persons with ADRD and challenging behaviors. Rapid data analysis informed the development of a 6-week online intervention. Phase 2 (NIH stage 1A) includes an open pilot (N>10) with optional exit interviews. Phase 3 (NIH stage 1B) is a feasibility randomized controlled trial of the intervention versus the Health Education Program control. Primary outcomes focus on feasibility with secondary outcomes encompassing acceptability, credibility, fidelity, and signals of preliminary efficacy. Phase 1 follows traditional recommendations for qualitative analyses (at the point of thematic saturation) which was achieved after 5 focus groups (N=28). For the phase 2 open pilot, up to 12 participants will be recruited. For the phase 3 feasibility study, recruitment of 80 caregivers will allow the assessment of feasibility benchmarks. Data for phase 1 included 5 focus groups. In phases 2 and 3, data collection will occur through REDCap (Research Electronic Data Capture; Vanderbilt University) surveys and an optional qualitative exit interview. Analyses will include hybrid inductive-deductive analyses for qualitative data and assessment of changes in our intervention targets and outcomes using t tests and correlation analyses. RESULTS: In phase 1, caregivers reported interest in a brief, online stress management program. Participants held misconceptions about mindfulness and self-compassion, but after detailed explanation thoughts, these skills could be helpful when directly linked to implementation during caregiving routines. Phases 2 and 3 will be completed by the end of 2025. CONCLUSIONS: We describe the protocol for the Supporting Our Caregivers in ADRD Learning study, as well as the development and feasibility testing of the Mindful and Self-Compassionate Care intervention. Future work will include a fully powered efficacy-effectiveness randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials NCT05847153; https://clinicaltrials.gov/study/NCT05847153; and ClinicalTrials.gov NCT06276023; https://clinicaltrials.gov/study/NCT06276023. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58356.

Medical Subject Headings (MeSH)
FemaleHumansMaleCaregiversDementiaEmpathyFocus GroupsMindfulnessStress, Psychological
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality80/10
Citation Metrics
Total Citations2
Citations/Year2.0
Research Impact Scores
APT Score0.50
Weight Score1.48
Normalized Score0.66
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