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Clinical Trials/NCT06200909
NCT06200909
Recruiting
Not Applicable

Caring for the Family Caregiver: Testing the Effect of Two Wellness Programs That Support the Well-being of Family Caregivers of Persons With Neurodegenerative Disorders

Toronto Metropolitan University1 site in 1 country232 target enrollmentJune 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregiver Burden
Sponsor
Toronto Metropolitan University
Enrollment
232
Locations
1
Primary Endpoint
Center for Epidemiological Studies - Depression
Status
Recruiting
Last Updated
2 years ago

Overview

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).

Detailed Description

The purpose of this study is to assess the benefits of 2 virtual self-care programs - mindfulness meditation or a psychoeducation support group - for family caregivers of persons with a neurodegenerative disorder. Both programs are 8-weeks in length. A third arm will include a respite-ony group, which may be considered "treatment as usual". Outcomes of interest include psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability). 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). The target sample is 232 family/informal caregivers, aged 50+ years old. All sessions will be conducted using the Zoom platform. Participants will be required to go to LifeLabs for blood collection. Blood results will be shared with participants.

Registry
clinicaltrials.gov
Start Date
June 2024
End Date
September 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexandra J. Fiocco, PhD

Professor

Toronto Metropolitan University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Center for Epidemiological Studies - Depression

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

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.

Perceived Stress Scale

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

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.

Secondary Outcomes

  • Zarit Burden Interview(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)
  • Flanker Task(Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.)

Study Sites (1)

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