Clinical trial NCT06276023: Supporting Our Caregivers In ADRD Learning (SOCIAL)
Official title: Supporting Our Caregivers In ADRD Learning (SOCIAL): Reducing Stress for Caregivers of Persons With Dementia, a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Quality of Life
Caregiver Stress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of California, San Francisco
First posted: 2024-02-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: Baseline
measure: Feasibility of Randomization
timeFrame: Baseline, Post intervention (6-8 weeks post baseline)
measure: Feasibility of Assessment Measures
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Feasibility of Quantitative Measures
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Adherence to treatment
timeFrame: Post-intervention
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Perceptions of Questionnaire Battery
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Adherence to Home Practice
timeFrame: Weekly (up to 6 weeks
measure: Perceptions of Email and Text Reminders
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Credibility and Expectancy
timeFrame: Baseline
measure: Modified Perception of Global Improvement
timeFrame: (6-8 weeks post baseline)
measure: Satisfaction with the Intervention
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Therapist Fidelity
timeFrame: Baseline through Post-intervention (6-8 weeks post baseline)
Secondary outcomes:
Other outcomes:
measure: Symptoms of Depression
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Mindfulness
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Perceived Stress Scale
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Symptoms of Anxiety
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: The Self-Compassion Scale
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Compassion
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Caregiver self-efficacy
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Loneliness
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Social Support
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Well-being
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Distress Due to Patient Challenges Behaviors
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
measure: Dyadic Relationship Scale
timeFrame: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Christine Ritchie, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
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