Clinical trial NCT05029193: Effectiveness of Mindfulness After a Stroke
Official title: Effectiveness of an Online Mindfulness Program for Stroke Survivors and Their Caregivers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Caregiver Burnout
Keywords: mindfulness
rehabilitation
caregiver
attention to variability
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Chapman University
First posted: 2021-08-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to a mindfulness intervention or a waitlist control. Participants in the waitlist control group will receive the intervention after a 2-month waiting period.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Severe language impairments
* Participation in regular meditation or a mindfulness program in past 3 months

Primary outcomes:
measure: Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2 months
measure: Change from baseline on NIH Toolbox Perceived Stress Survey (PSS)
timeFrame: 2 months
measure: Change from baseline on Single-item Sleep Quality Scale (SQS)
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline on Stroke-specific Quality of Life (SS-QOL)
timeFrame: 2 months
measure: Change from baseline on World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 2 months
measure: Change from baseline on Zarit Burden Interview
timeFrame: 2 months
measure: change in the modified Ashworth Scale (elbow)
timeFrame: 2 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Carolee Winstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: