Clinical trial NCT05847153: MASC: Reducing Stress for Caregivers
Official title: The Mindful and Self-Compassionate Care Program Aim 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease and Related Dementias
Dementia Alzheimers
Keywords: ADRD
Caregiver stress
Dementia
Alzheimer
Self-compassion
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2023-05-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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 has 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Building on limitations of prior research, the investigators proposed to develop 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.

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 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 (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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Recent change ini psychotropic treatment for depression or anxiety
* 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

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: Baseline
measure: Number of Participants With Less Than 25% of Missing Questionnaires at Baseline
timeFrame: Baseline
measure: Number of Participants With Less Than 25% of Missing Questionnaires at Post-Intervention
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Number of Participants With no Questionnaries Missing Fully at Baseline
timeFrame: Baseline
measure: Number of Participants With no Questionnaries Missing Fully at Post-intervention
timeFrame: Post-intervention (6-8 weeks post baseline)
Secondary outcomes:
Other outcomes:
measure: Symptoms of Depression
timeFrame: Baseline
measure: Symptoms of Depression
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Mindfulness
timeFrame: Baseline
measure: Mindfulness
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Perceived Stress Scale
timeFrame: Baseline
measure: Perceived Stress Scale
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Symptoms of Anxiety
timeFrame: Baseline
measure: Symptoms of Anxiety
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: The Self-Compassion Scale
timeFrame: Baseline
measure: The Self-Compassion Scale
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Compassion
timeFrame: Baseline
measure: Compassion
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Caregiver Self-efficacy
timeFrame: Baseline
measure: Caregiver Self-efficacy
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Loneliness
timeFrame: Baseline
measure: Loneliness
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Social Support
timeFrame: Baseline
measure: Social Support
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Well-being
timeFrame: Baseline
measure: Well-being
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Distress Due to Patient Challenges Behaviors
timeFrame: Baseline
measure: Distress Due to Patient Challenges Behaviors
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Satisfaction With the Intervention
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Therapist Fidelity
timeFrame: Baseline through Post-intervention (6-8 weeks post baseline)
measure: Perceptions of Questionnaire Battery
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Adherence to Home Practice
timeFrame: Weekly (up to 5 weeks)
measure: Perceptions of Email and Text Reminders
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Credibility and Expectancy
timeFrame: Post-Intervention
measure: Applied Mindfulness Process Scale
timeFrame: Baseline
measure: Applied Mindfulness Process Scale
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Modified Perception of Global Improvement
timeFrame: Post-intervention (6-8 weeks post baseline)
measure: Positive Affect Index
timeFrame: Baseline
measure: Positive Affect Index
timeFrame: Post-intervention (6-8 weeks post baseline)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christine S Ritchie, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Roche V. The hidden patient: addressing the caregiver. Am J Med Sci. 2009 Mar;337(3):199-204. doi: 10.1097/MAJ.0b013e31818b114d.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.