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Alzheimer's Disease and Related DementiasSOCIALNCT06276023

Supporting Our Caregivers In ADRD Learning (SOCIAL)

A study testing Mindful and Self-Compassionate Care Program (MASC) and Health Education Program (HEP) in people with Alzheimer's Disease and Related Dementias and Quality of Life, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Mindful and Self-Compassionate Care Program (MASC) and Health Education Program (HEP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
22 Mar 2024to 28 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-2524

Other trials in United States

About this study

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

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.

Read the 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 a randomized-controled trial (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.

Being tested
Mindful and Self-Compassionate Care Program (MASC), Health Education Program (HEP)
Medical subject headings
Alzheimer Disease, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful and Self-Compassionate Care Program (MASC)Behavioural

    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.

  • Health Education Program (HEP)Behavioural

    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.

Study groups in NCT06276023
Study groupRoleWhat they receive
Mindful and Self-Compassionate Care Program (MASC)ExperimentalThe 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.
Receives: Behavioral: Mindful and Self-Compassionate Care Program (MASC)
Health Education Program (HEP)Active comparatorThe 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.
Receives: Behavioral: Health Education Program (HEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Recruitment

    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.

    Measured: Baseline

  2. Feasibility of Randomization

    The percentage randomized who complete the post-test.

    Measured: Baseline, Post intervention (6-8 weeks post baseline)

  3. Feasibility of Assessment Measures

    The proportion of participants who completed the study and had fewer than 25% of all expected study questionnaires missing across the entire assessment period. This participant-level measure assessed overall study completion and questionnaire adherence.

    Measured: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention

  4. Feasibility of Quantitative Measures

    Assessing whether at least 75% of participants completed every study question in the questionnaire (of note: no questionnaire in this study was entirely missing). The benchmark was met if no more than 25% of participants had one or more questionnaires that were completely missing.

    Measured: Baseline, Post-intervention (6-8 weeks post baseline), 3-months post intervention

  5. Adherence to Treatment

    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.

    Measured: Post-intervention (Up to 8 weeks post baseline)

  6. Patient's Global Impression of Change (PGIC)

    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"

    Measured: Post-intervention (6-8 weeks post baseline)

  7. Perceptions of Questionnaire Battery

    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.

    Measured: Post-intervention (6-8 weeks post baseline)

  8. Adherence to Home Practice

    The proportion of participants who complete more than 50% weekly home practice.

    Measured: Weekly (up to 6 weeks

  9. Perceptions of Email and Text Reminders

    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?"

    Measured: Post-intervention (6-8 weeks post baseline)

  10. Credibility and Expectancy

    The Credibility and Expectancy Questionnaire (CEQ) assesses participants' perceptions that the treatment will work after participating in the intervention. It consists of 6 items divided into two subscales, with scoring is based on dividing the items into Credibility and Expectancy. Items 1-3: Assess Treatment Credibility, scored on a 1 to 9 scale (where 1 represents "not at all" and 9 represents "very much"; the subscale score is the sum of these three items, range: 3-27; a higher score indicates a better outcome). Items 4-6: Assess Treatment Expectancy, scored on a 0% to 100% scale (values are recoded to match the 1 to 9 scale of the previous items; once recoded, values range from 3-27; higher scores represent a better outcome). Credibility Score: Calculate the sum (or average) of items 1-3; a higher score indicates a better outcome. Expectancy Score: Calculate the sum (or average) of items 4-6; a higher score indicates a better outcome.

    Measured: Baseline

  11. Modified Perception of Global Improvement

    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. The MPGI uses a 7-point Likert scale, with 1 = Very Much Improved and 7 = Very Much Worse (lower score represents a better outcome).

    For the data below, the scores were converted as follows:

    Improved - original scores of 1-3 converted to a zero Not improved - original score 4-7 converted to a 1. The averages of the converted scores were computed, with a score ranging from 0-1 (with a lower score representing a better outcome).

    Measured: (6-8 weeks post baseline)

  12. Satisfaction With the Intervention

    The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention. Each of the three questions is scored on a 4-point Likert scale ranging from 1 to 4, where higher numbers indicate greater satisfaction. To calculate the score, you add up the responses from the three questions. Total Score Range: 3 to 12 (higher score represents better outcome).

    Measured: Post-intervention (6-8 weeks post baseline)

  13. Therapist Fidelity

    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). To measure this outcome, recorded sessions were analyzed.

    Measured: Baseline through Post-intervention (6-8 weeks post baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start22 Mar 2024
  3. Primary completion28 May 2025
  4. Study completion28 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
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.
Masking
Single blind
Who is masked
Participant
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06276023
Sponsor's protocol ID
2023P003638
Other IDs
R01AG078204-01
Acronym
SOCIAL
Status last verified
Aug 2026
First submitted
18 Feb 2024
Last updated
2 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 2021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.

    PubMed 33756057

  • Jutkowitz E, Kane RL, Gaugler JE, MacLehose RF, Dowd B, Kuntz KM. Societal and Family Lifetime Cost of Dementia: Implications for Policy. J Am Geriatr Soc. 2017 Oct;65(10):2169-2175. doi: 10.1111/jgs.15043. Epub 2017 Aug 17.

    PubMed 28815557

  • Roche V. The hidden patient: addressing the caregiver. Am J Med Sci. 2009 Mar;337(3):199-204. doi: 10.1097/MAJ.0b013e31818b114d.

    PubMed 19282676

  • Sorensen S, Conwell Y. Issues in dementia caregiving: effects on mental and physical health, intervention strategies, and research needs. Am J Geriatr Psychiatry. 2011 Jun;19(6):491-6. doi: 10.1097/JGP.0b013e31821c0e6e. No abstract available.

    PubMed 21502853

  • Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.

    PubMed 19585957

  • Lewinsohn PM, Seeley JR, Roberts RE, Allen NB. Center for Epidemiologic Studies Depression Scale (CES-D) as a screening instrument for depression among community-residing older adults. Psychol Aging. 1997 Jun;12(2):277-87. doi: 10.1037//0882-7974.12.2.277.

    PubMed 9189988

  • Li MJ, Black DS, Garland EL. The Applied Mindfulness Process Scale (AMPS): A process measure for evaluating mindfulness-based interventions. Pers Individ Dif. 2016 Apr 1;93:6-15. doi: 10.1016/j.paid.2015.10.027.

    PubMed 26858469

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

    PubMed 21584907

  • Pommier E, Neff KD, Toth-Kiraly I. The Development and Validation of the Compassion Scale. Assessment. 2020 Jan;27(1):21-39. doi: 10.1177/1073191119874108. Epub 2019 Sep 13.

    PubMed 31516024

  • Steffen AM, McKibbin C, Zeiss AM, Gallagher-Thompson D, Bandura A. The revised scale for caregiving self-efficacy: reliability and validity studies. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P74-86. doi: 10.1093/geronb/57.1.p74.

    PubMed 11773226

  • Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.

    PubMed 8576833

  • Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

    PubMed 11132119

  • Merz EL, Roesch SC, Malcarne VL, Penedo FJ, Llabre MM, Weitzman OB, Navas-Nacher EL, Perreira KM, Gonzalez F, Ponguta LA, Johnson TP, Gallo LC. Validation of interpersonal support evaluation list-12 (ISEL-12) scores among English- and Spanish-speaking Hispanics/Latinos from the HCHS/SOL Sociocultural Ancillary Study. Psychol Assess. 2014 Jun;26(2):384-94. doi: 10.1037/a0035248. Epub 2013 Dec 9.

    PubMed 24320763

  • Attkisson CC, Greenfield TK. The Client Satisfaction Questionnaire (CSQ) and Scales and the Service Satisfaction Scale-30 (SSS-30).

Questions about this trial

What is this clinical trial studying?

A study testing Mindful and Self-Compassionate Care Program (MASC) and Health Education Program (HEP) in people with Alzheimer's Disease and Related Dementias and Quality of Life, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06276023, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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