Supporting Our Caregivers In ADRD Learning (SOCIAL)

Not Applicable

Active, not recruiting

• Conditions: Quality of Life; Caregiver Stress; Alzheimer's Disease and Related Dementias
• Interventions: Behavioral: Health Education Program (HEP); Behavioral: Mindful and Self-Compassionate Care Program (MASC)

• Registration Number: NCT06276023
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-18
• Study First Posted: 2024-02-23
• Study Start: 2024-03-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-05-26
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 82

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 change in psychotropic treatment for depression or anxiety
• Use of mindfulness apps or any meditation (more than 60 min/week in past 6 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health Education Program (HEP)	Health Education Program (HEP)	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.
Mindful and Self-Compassionate Care Program (MASC)	Mindful and Self-Compassionate Care Program (MASC)	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of Recruitment	Baseline	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.
Feasibility of Randomization	Baseline, Post intervention (6-8 weeks post baseline)	The percentage randomized who complete the post-test.
Feasibility of Quantitative Measures	Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention	The benchmark of no questionnaires missing fully in ≥25% of caregivers.
Adherence to treatment	Post-intervention	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.
Perceptions of Questionnaire Battery	Post-intervention (6-8 weeks post baseline)	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.
Perceptions of Email and Text Reminders	Post-intervention (6-8 weeks post baseline)	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?"
Credibility and Expectancy	Baseline	The Credibility and Expectancy Questionnaire (CEQ) assesses participants' perceptions that the treatment will work after participating in the intervention.
Feasibility of Assessment Measures	Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention	The proportion of participants who complete the study with less than 25% of missing questionnaires.
Patient's Global Impression of Change (PGIC)	Post-intervention (6-8 weeks post baseline)	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"
Adherence to Home Practice	Weekly (up to 6 weeks	The proportion of participants who complete weekly home practice.
Therapist Fidelity	Baseline through Post-intervention (6-8 weeks post baseline)	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).
Modified Perception of Global Improvement	(6-8 weeks post baseline)	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.
Satisfaction with the Intervention	Post-intervention (6-8 weeks post baseline)	The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States