Effectiveness of Mindfulness After a Stroke
- Conditions
- StrokeCaregiver Burnout
- Interventions
- Behavioral: Langerian mindfulness
- Registration Number
- NCT05029193
- Lead Sponsor
- University of Southern California
- Brief Summary
Mindfulness is promising for individuals with neurological disorders and caregivers to improve psychological well-being. This study aims to determine the extent to which a 3-week online mindfulness intervention will improve quality of life and psychological well-being for chronic stroke survivors and their caregivers, compared to a waitlist control.
- Detailed Description
Background: The incidence of depression and anxiety is much higher in stroke survivors and their caregivers compared to age-matched peers. Previous work suggests that mindfulness delivered in an online format is promising for both individuals with neurological disorders and caregivers to improve quality of life and psychological well-being.
Aim: This project aims to determine the extent to which a 3-week online mindfulness intervention will improve quality of life and psychological well-being for chronic stroke survivors and their caregivers, compared to a waitlist control. The primary hypothesis is that participants in the mindfulness group will demonstrate greater improvement in quality of life and psychological well-being post-intervention compared to waitlist control participants. The secondary hypothesis is that these improvements will persist for at least 1-month post-intervention.
Methods: This project uses a pragmatic, randomized, waitlist-control trial design with blinded outcome assessment. Participants (stroke survivors and caregivers) are assigned to a 3-week online mindfulness intervention, or a 2-month delayed waitlist. A battery of self-reported outcome measures and clinical tests are administered pre-intervention, post-intervention and at 1-month follow-up. Participants in the waitlist control group are also assessed at enrollment. A sample of 44 stroke survivors and 44 caregivers is targeted. Changes will be measured using a repeated analysis of variance.
Conclusion: The study constitutes the initial step to understand the role of mindfulness exercises delivered remotely and the potential benefit of the intervention for stroke survivors across a wide range of disability level and their caregivers.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 28
- Stroke survivor or caregiver of someone who have had a stroke
- Fluent in English
- Have access to Internet using a computer, a tablet and/or a smart phone.
- Severe language impairments
- Participation in regular meditation or a mindfulness program in past 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Stroke survivors - Mindfulness intervention Langerian mindfulness Participants who have had a stroke who are receiving the mindfulness intervention immediately after enrollment (no wait period). Caregivers - Mindfulness intervention Langerian mindfulness Participants caring for someone who have had a stroke and receiving the mindfulness intervention immediately after enrollment (no wait period).
- Primary Outcome Measures
Name Time Method Change from baseline on the Hospital Anxiety and Depression Scale (HADS) 2 months The HADS assesses depression and anxiety. It is a 14-item scale with 7 items each for anxiety and depression subscales. Each item is scored from 0 to 3, with higher scores indicating higher anxiety or depressive symptoms.
Change from baseline on Single-item Sleep Quality Scale (SQS) 2 months The SQS assesses sleep quality and includes an 11-point visual analogue scale about sleep quality in the past week (0: poor, 10: excellent sleep quality).
Change from baseline on NIH Toolbox Perceived Stress Survey (PSS) 2 months The PSS assesses perceived stress. It includes 10 items about the occurrence of life stressors scored from 0 (never) to 4 (very often). Higher scores indicate higher perceived stress.
- Secondary Outcome Measures
Name Time Method Change from baseline on Stroke-specific Quality of Life (SS-QOL) 2 months The SS-QOL assesses health-related quality of life for stroke survivors. It contains 49 items in 12 domains. Items are rated on a 5-point Likert scale from 1 to 5, with higher scores indicating better functioning.
Change from baseline on World Health Organization Quality of Life-BREF (WHOQOL-BREF) 2 months The WHOQOL assesses health-related quality of life and is used in this study to assess caregivers. It comprises 26 questions from 4 domains about health and well-being. The scores are normalized, and higher scores indicate better perceived health and well-being.
Change from baseline on Zarit Burden Interview 2 months The Zarit Burden Interview includes 22 questions about caregiver burden rated from 0 (never) to 4 (nearly always). Higher scores indicate higher perceived burden.
change in the modified Ashworth Scale (elbow) 2 months Measure of spasticity in the flexor and extensor muscles of the elbow. The scores range from 0 to 4, with higher scores indicating more spasticity.
Trial Locations
- Locations (1)
University of Southern California
🇺🇸Los Angeles, California, United States