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.
Over half of Alzheimer Disease and Related Dementias (ADRD) caregivers are actively looking for non-pharmacological interventions to decrease caregiver stress. Available programs do not sufficiently meet the psychological and practical needs of stressed caregivers of persons with ADRD; better solutions are needed. First, while helpful, most support groups do not systematically teach behavioral management skills which caregivers report needing in order to manage challenging patient behaviors. Second, behavioral management skills interventions exist, but do not teach: 1) emotional regulation skills which are necessary in order to foster caregiver ability to access and use these skills to manage patient behaviors, and/or 2) self-compassion and compassion skills which are necessary to bypass guilt and loneliness and navigate behavioral symptoms which are common caregiver challenges. Third, mindfulness and self-compassion interventions are effective solutions for managing stress, and distress across multiple populations, but engagement and efficacy among diverse ADRD caregivers are limited. The guiding hypothesis of this proposal is that combining evidence-based mindfulness and self-compassion skills with behavioral management skills within a multi-component program increases intervention potency and efficiently supports caregivers of persons with ADRD. Accounting for practical challenges to engagement (number of sessions, delivery modality, skill practice) will also enhance uptake and reach. The investigators will conduct an RCT study to explore feasibility benchmarks, target engagement and signal of improvement in stress, depression, anxiety and wellbeing (NIH stage 1B; N= up to 88 caregivers). The investigators will recruit caregivers of persons with ADRD from local community organizations and caregiver support programs; dementia research programs; and from national programs that focus on caregiving.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
82
The intervention arm will be comprised of: Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
The control arm will be comprised of: Six Virtual Group Sessions. The sessions will discuss caregiver stress, sleep hygiene, nutrition, and ways to stay physically active as a caregiver. At Home Practice. After each group session, participants will have the opportunity to complete journal exercises that encourage them to integrate the health information that they learn into their daily lives.
Massachusetts General Hospital
Boston, Massachusetts, United States
Feasibility of Recruitment
The proportion of eligible participants who are eligible and choose to enroll in the study and the percentage of racial and ethnically diverse participants enrolled.
Time frame: Baseline
Feasibility of Randomization
The percentage randomized who complete the post-test.
Time frame: Baseline, Post intervention (6-8 weeks post baseline)
Feasibility of Assessment Measures
The proportion of participants who complete the study with less than 25% of missing questionnaires.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
Feasibility of Quantitative Measures
The benchmark of no questionnaires missing fully in ≥25% of caregivers.
Time frame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
Adherence to treatment
The proportion of caregivers who attend at least 4 out of the 6 sessions out of all randomized caregivers. Adherence to treatment will be estimated for both HEP and MASC.
Time frame: Post-intervention
Patient's Global Impression of Change (PGIC)
PGIC is a 7-point scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse" or "very much worse"
Time frame: Post-intervention (6-8 weeks post baseline)
Perceptions of Questionnaire Battery
The 'Perceptions of Questionnaire Battery' qualitative measure assesses how appropriately the participants fill the questionnaires, address their perception of stress, emotional distress and all other questionnaires.
Time frame: Post-intervention (6-8 weeks post baseline)
Adherence to Home Practice
The proportion of participants who complete weekly home practice.
Time frame: Weekly (up to 6 weeks
Perceptions of Email and Text Reminders
Participants' perception of emails and text messages reminders. The single question -, "Do participants think that the number of emails/texts received was: too little, just enough, too much?"
Time frame: Post-intervention (6-8 weeks post baseline)
Credibility and Expectancy
The Credibility and Expectancy Questionnaire (CEQ) assesses participants' perceptions that the treatment will work after participating in the intervention.
Time frame: Baseline
Modified Perception of Global Improvement
The Modified Perception of Global Improvement (MPGI) is a global index designed to measure a participant's interpretation of changes in perceptions of stress following intervention.
Time frame: (6-8 weeks post baseline)
Satisfaction with the Intervention
The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention.
Time frame: Post-intervention (6-8 weeks post baseline)
Therapist Fidelity
Ability of therapist to deliver the content of each session (through therapist completed adherence checklists) and therapist fidelity (through independent review of recorded sessions by Co-Investigator).
Time frame: Baseline through Post-intervention (6-8 weeks post baseline)
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