Self-Care Training for Family Caregivers of Persons With Neurodegeneration

NCT06200909 | Recruiting DMC

• 1 other identifier: REB 2022-003
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether an 8-week mindfulness program enhances psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability) in primary family caregivers of persons with dementia or a related neurodegenerative disease. A total of 232 primary family caregivers aged 50+ years of age will be recruited for this study and randomized to one of three groups: mindfulness meditation (MM), psychoeducation (PSY) or caregiver respite (CR). All participants will complete three testing sessions: baseline (pre-intervention \[T1\]), post 8-week follow-up (post-intervention, \[T2\]), and 12-month follow-up (T3).

Conditions

Caregiver Burden; Caregiver Stress

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Scale

  10-item Likert-type scale that measured level of distress in the past month. The questionnaire will be modified to cover the past 2 weeks. Higher scores (range 0-40) indicate greater perceived stress.

  Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

• Center for Epidemiological Studies - Depression

  A 20-item Likert-type questionnaire that measures presence of depressive symptoms in the past week. Higher scores (range 0-60) indicate greater depressive symptoms.

  Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

Secondary Outcomes (3)

• Zarit Burden Interview

  Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

• Flanker Task

  Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

• Allostatic Load Index

  Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up

Other Outcomes (7)

• Difficulties in Emotion Regulation - Short Form

  Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

• Five Factor Mindfulness Questionnaire - Short Form

  Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

• Pearlin Mastery Scale

  Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

Study Arms (3)

Mindfulness Meditation (MM)

EXPERIMENTAL

8-week mindfulness meditation program is based on Kabat-Zinn's MBSR program and will be led by MBSR-trained facilitators. The program has been modified to make it more accessible to caregivers. Weekly sessions will be 120-minutes long (instead of original 150-180-minute sessions). Formal meditation practices described in the original MBSR program (i.e., body scan, sitting meditation, mindful movement, mindful eating and walking) will be taught, in addition to loving kindness meditation (LKM). Participants will be given guided meditation recordings and compliance with home practice will be monitored with a practice log. The prescribed home practice has been modified to accommodate the needs of the caregiver: each practice is offered in 5- to 10-minute intervals (5 min, 10 min, and 20 min practice) to accommodate the caregiver's schedule.

Other: Mindfulness Meditation

Psychoeducation

ACTIVE COMPARATOR

Psychoeducation (PSY) condition will be similar to MM with respect to number and duration of weekly sessions and daily homework. PSY is a lecture-based program based on the "10 Keys"TM to Healthy Aging Course, an evidence-based program for older adults. Each session focuses on a specific topic related to wellness (e.g., nutrition, physical activity, medical screening) and caregiver-specific topics (e.g., understanding dementia and neurodegenerative disease, legal and financial issues).

Other: Psychoeducation

Respite control

ACTIVE COMPARATOR

Participant allocated to RC will not be exposed to a program, but will be offered 120-minutes of weekly respite care. Caregivers will be asked to record how they spend respite hours each week.

Other: Wait list control

Interventions

Mindfulness Meditation OTHER

8-week mindfulness meditation program, based on Kabat-Zinn's MBSR program and modified for caregivers. The intervention will be led by MBSR-trained facilitators.

Mindfulness Meditation (MM)

Psychoeducation OTHER

A lecture-style program based on the "10 Keys"TM to Healthy Aging Course, an evidence-based program for older adults. The program will be delivered by a facilitator experienced in delivering similar content.

Psychoeducation

Wait list control OTHER

Participants will receive two hours of respite from their caregiving responsibilities per week, for eight weeks. They will be given the opportunity to participate in either the MM or the PSY condition following completion of testing.

Respite control

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Currently a primary family caregiver
• Fluent in English

You may not qualify if:

• Existing mindfulness practice
• Diagnosed/Presenting with Post-traumatic Stress Disorder; Substance Disorder; Psychosis
• Unable to attend 8 sessions
• No access to a computer or high-speed internet
• Not willing to be randomized

Sponsors & Collaborators

• Toronto Metropolitan University: lead

Study Sites (1)

Toronto Metropolitan University

Toronto, Ontario, M5B 2K3, Canada

RECRUITING

Related Publications (10)

• 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

• Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and Replication in Adolescent and Adult Samples. J Psychopathol Behav Assess. 2016;38(3):443-455. doi:10.1007/s10862-015-9529-3

  BACKGROUND

• Radloff LS. The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement. 1977;1(3):385-401. doi:10.1177/014662167700100306

  BACKGROUND

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 BACKGROUND

• Juster RP, Bizik G, Picard M, Arsenault-Lapierre G, Sindi S, Trepanier L, Marin MF, Wan N, Sekerovic Z, Lord C, Fiocco AJ, Plusquellec P, McEwen BS, Lupien SJ. A transdisciplinary perspective of chronic stress in relation to psychopathology throughout life span development. Dev Psychopathol. 2011 Aug;23(3):725-76. doi: 10.1017/S0954579411000289.

  PMID: 21756430 BACKGROUND

• Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011 Sep;18(3):308-20. doi: 10.1177/1073191111408231. Epub 2011 May 17.

  PMID: 21586480 BACKGROUND

• Pearlin LI, Lieberman MA, Menaghan EG, Mullan JT. The stress process. J Health Soc Behav. 1981 Dec;22(4):337-56. No abstract available.

  PMID: 7320473 BACKGROUND

• Neff KD. The Development and Validation of a Scale to Measure Self-Compassion. Self and Identity. 2003;2(3):223-250. doi:10.1080/15298860309027

  BACKGROUND

• Power MJ. Quality of life. In: Lopez SJ, Snyder CR, eds. Positive Psychological Assessment: A Handbook of Models and Measures. American Psychological Association; 2003:427-441. doi:10.1037/10612-027

  BACKGROUND

• Gilbert P, Basran J, Plowright P, Matos M, Kirby J, Petrocchi N. Fears and Resistances to Mindfulness: Development of a Self-Report Scale. Mindfulness. 2023;14(11):2602-2616. doi:10.1007/s12671-023-02171-y

  BACKGROUND

MeSH Terms

Conditions

Caregiver Burden

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alexandra Fiocco, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rhiannon Ueberholz, BA

CONTACT

416-979-5000; star.lab@torontomu.ca

Alexandra Fiocco, PhD

CONTACT

416-979-5000; afiocco@torontomu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers who engage in pre-post testing assessment will be blinded to participant allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective single-blinded mixed methods randomized controlled superiority trial, with participants randomized in blocks of 8-12 to either MM, PSY, or RC.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 11, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)