Supporting Our Caregivers In ADRD Learning (SOCIAL)

Mass General Brigham

Status: Completed

Conditions: Quality of Life; Alzheimer's Disease and Related Dementias; Caregiver Stress

Treatments: Behavioral: Health Education Program (HEP); Behavioral: Mindful and Self-Compassionate Care Program (MASC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06276023

R01AG078204-01 (U.S. NIH Grant/Contract)

2023P003638

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• English fluency and literacy
• Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care)
• Must live with and care for an individual with ADRD
• Must have been in a caregiver role for more than 6 months
• Must provide an average 4 hours of supervision or direct assistance per day for the are recipient
• Perceived Stress Scale-4 (4-item) version ≥ 6
• Had managed 1 or more behavioral symptoms in past month

Exclusion criteria

• Recent (within the past 6 weeks) change in prescribed medications for depression or anxiety
• Use of mindfulness apps or any meditation (more than 60 min/week in past 3 months)
• Involvement in another clinical trial for caregivers, a score ≥ 4 on the Portable Mental Status Questionnaire (PMSQ)
• No stated concerns or distress related to care recipient's disruptive behaviors
• Involvement in another clinical trial for caregivers

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Mindful and Self-Compassionate Care Program (MASC)

Experimental group

Description:

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.

Treatment:

Behavioral: Mindful and Self-Compassionate Care Program (MASC)

Health Education Program (HEP)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education Program (HEP)