Supporting Our Caregivers In ADRD Learning (SOCIAL)

NCT06276023 | Completed

• 2 other identifiers: 2023P003638R01AG078204-01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (13)

• 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.

  Baseline

• Feasibility of Randomization

  The percentage randomized who complete the post-test.

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

• Feasibility of Assessment Measures

  The proportion of participants who complete the study with less than 25% of missing questionnaires.

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

• Feasibility of Quantitative Measures

  The benchmark of no questionnaires missing fully in ≥25% of caregivers.

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

• 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.

  Post-intervention

• 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"

  Post-intervention (6-8 weeks post baseline)

• 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.

  Post-intervention (6-8 weeks post baseline)

• Adherence to Home Practice

  The proportion of participants who complete weekly home practice.

  Weekly (up to 6 weeks

• 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?"

  Post-intervention (6-8 weeks post baseline)

• Credibility and Expectancy

  The Credibility and Expectancy Questionnaire (CEQ) assesses participants' perceptions that the treatment will work after participating in the intervention.

  Baseline

• 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.

  (6-8 weeks post baseline)

• Satisfaction with the Intervention

  The investigators will use the Client Satisfaction Questionnaire (CSQ-3) to assess participants' satisfaction with the intervention.

  Post-intervention (6-8 weeks post baseline)

• 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).

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

Other Outcomes (12)

• Symptoms of Depression

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

• Mindfulness

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

• Perceived Stress Scale

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

Study Arms (2)

Mindful and Self-Compassionate Care Program (MASC)

EXPERIMENTAL

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.

Behavioral: Mindful and Self-Compassionate Care Program (MASC)

Health Education Program (HEP)

ACTIVE COMPARATOR

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.

Behavioral: Health Education Program (HEP)

Interventions

Mindful and Self-Compassionate Care Program (MASC) BEHAVIORAL

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.

Mindful and Self-Compassionate Care Program (MASC)

Health Education Program (HEP) BEHAVIORAL

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.

Health Education Program (HEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2524, United States

Location

Related Publications (16)

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

  PMID: 33756057 BACKGROUND

• 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.

  PMID: 28815557 BACKGROUND

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

  PMID: 19282676 BACKGROUND

• 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.

  PMID: 21502853 BACKGROUND

• 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.

  PMID: 19585957 BACKGROUND

• 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.

  PMID: 9189988 BACKGROUND

• 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.

  PMID: 26858469 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 21584907 BACKGROUND

• 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.

  PMID: 31516024 BACKGROUND

• 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.

  PMID: 11773226 BACKGROUND

• 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.

  PMID: 8576833 BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

• 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.

  PMID: 24320763 BACKGROUND

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

  BACKGROUND

• Travis A, O'Donnell A, Giraldo-Santiago N, Stone SM, Torres D, Adler SR, Vranceanu AM, Ritchie CS. Intervention for the Management of Neuropsychiatric Symptoms to Reduce Caregiver Stress: Protocol for the Mindful and Self-Compassion Care Intervention for Caregivers of Persons Living With Dementia. JMIR Res Protoc. 2024 Oct 11;13:e58356. doi: 10.2196/58356.

  PMID: 39392675 DERIVED

Related Links

• Evercare study of caregivers in decline: a close-up look at the health risks of caring for a loved one.
• Spielberger State-Trait Anxiety Inventory
• Measuring the Dimension of Psychological General Well-Being by the WHO-5

MeSH Terms

Conditions

Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Christine Ritchie, MD, MSPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 23, 2024
• Study Start: March 22, 2024
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-04

Locations

US (1)