NCT06276023Completed
Supporting Our Caregivers In ADRD Learning (SOCIAL)
Supporting Our Caregivers In ADRD Learning (SOCIAL): Reducing Stress for Caregivers of Persons With Dementia, a Pilot Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 18 Feb 2024
- Start date
- 22 Mar 2024
- Primary completion date
- 28 May 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT06276023
What you commit to
- Study type: Interventional
- Participants enrolled: 82
- From 22 Mar 2024 to the primary completion date, 28 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (within the past 6 weeks) change in prescribed medications for depression or anxiety
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.