Study Results
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View full resultsBasic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2023-09-12
2024-01-13
Brief Summary
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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 (nr. sessions, delivery modality, skill practice) will also enhance uptake and reach.
The investigators will conduct an open pilot with exit interviews to explore feasibility benchmarks, target engagement and signal of improvement in stress, depression, anxiety and wellbeing (NIH stage 1A; N= up to 20 caregivers; N= up to 2 groups. Exit interviews will last 30 minutes and will be recorded, transcribed, and analyzed to refine study procedures. The investigators will use this information to revise and optimize MASC and our conceptual model, as needed to maximize feasibility and target engagement.
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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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
The intervention arm will be comprised of:
1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills.
2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
MASC
The intervention arm will be comprised of:
1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills.
2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
Interventions
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MASC
The intervention arm will be comprised of:
1. Six Virtual Group Sessions. The sessions will teach mindfulness, self-compassion and behavioral management skills.
2. At Home Practice. After each group session, participants will have the opportunity to integrate the practices learned into their everyday life.
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 6 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 Institutes of Health (NIH)
NIH
National Institute on Aging (NIA)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Christine S. Ritchie, MD, MPH
Professor of Medicine
Principal Investigators
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Christine S Ritchie, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Ana-Maria Vranceanu, PhD
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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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.
Jennings LA, Reuben DB, Evertson LC, Serrano KS, Ercoli L, Grill J, Chodosh J, Tan Z, Wenger NS. Unmet needs of caregivers of individuals referred to a dementia care program. J Am Geriatr Soc. 2015 Feb;63(2):282-9. doi: 10.1111/jgs.13251.
Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23.
Pedro J, Monteiro-Reis S, Carvalho-Maia C, Henrique R, Jeronimo C, Silva ER. Evidence of psychological and biological effects of structured Mindfulness-Based Interventions for cancer patients and survivors: A meta-review. Psychooncology. 2021 Nov;30(11):1836-1848. doi: 10.1002/pon.5771. Epub 2021 Jul 28.
Conversano C, Orru G, Pozza A, Miccoli M, Ciacchini R, Marchi L, Gemignani A. Is Mindfulness-Based Stress Reduction Effective for People with Hypertension? A Systematic Review and Meta-Analysis of 30 Years of Evidence. Int J Environ Res Public Health. 2021 Mar 11;18(6):2882. doi: 10.3390/ijerph18062882.
Al-Refae M, Al-Refae A, Munroe M, Sardella NA, Ferrari M. A Self-Compassion and Mindfulness-Based Cognitive Mobile Intervention (Serene) for Depression, Anxiety, and Stress: Promoting Adaptive Emotional Regulation and Wisdom. Front Psychol. 2021 Mar 22;12:648087. doi: 10.3389/fpsyg.2021.648087. eCollection 2021.
Mahaffey BL, Mackin DM, Vranceanu AM, Lofaro L, Bromet EJ, Luft BJ, Gonzalez A. The Stony Brook Health Enhancement Program: The development of an active control condition for mind-body interventions. J Health Psychol. 2020 Nov-Dec;25(13-14):2129-2140. doi: 10.1177/1359105318787024. Epub 2018 Jul 16.
Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud. 2015;1(1):1. doi: 10.1186/2055-5784-1-1. Epub 2015 Jan 12.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2023P001130
Identifier Type: -
Identifier Source: org_study_id
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