Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2024-03-22
2025-05-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, San Francisco
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Christine S. Ritchie, MD, MPH
Professor of Medicine
Principal Investigators
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Ana-Maria Vranceanu, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Christine Ritchie, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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2021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.
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.
Roche V. The hidden patient: addressing the caregiver. Am J Med Sci. 2009 Mar;337(3):199-204. doi: 10.1097/MAJ.0b013e31818b114d.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Attkisson CC, Greenfield TK. The Client Satisfaction Questionnaire (CSQ) and Scales and the Service Satisfaction Scale-30 (SSS-30).
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.
Related Links
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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
Other Identifiers
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2023P003638
Identifier Type: -
Identifier Source: org_study_id
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