Supporting Our Caregivers In ADRD Learning (SOCIAL) — SOCIAL  

Quality of Life Clinical Trial

Official title: Supporting Our Caregivers In ADRD Learning (SOCIAL): Reducing Stress for Caregivers of Persons With Dementia, a Pilot Randomized Control Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 80 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Related Dementias
• Caregiver Stress
• Dementia
• Quality of Life

• NCT number: NCT06276023
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Aniyah Travis, MPH
• Phone: 6177269623
• Email: atravis1@mgh.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Completion date: April 1, 2025