Study Results
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Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2021-09-13
2023-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Stroke survivors - Mindfulness intervention
Participants who have had a stroke who are receiving the mindfulness intervention immediately after enrollment (no wait period).
Langerian mindfulness
A 3-week Langerian mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.
Stroke survivors - Waitlist control
Participants who have had a stroke who are assigned to the waitlist.
No interventions assigned to this group
Caregivers - Mindfulness intervention
Participants caring for someone who have had a stroke and receiving the mindfulness intervention immediately after enrollment (no wait period).
Langerian mindfulness
A 3-week Langerian mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.
Caregivers - Waitlist control
Participants caring for someone who have had a stroke assigned to the waitlist.
No interventions assigned to this group
Interventions
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Langerian mindfulness
A 3-week Langerian mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.
Eligibility Criteria
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Inclusion Criteria
* Fluent in English
* Have access to Internet using a computer, a tablet and/or a smart phone.
Exclusion Criteria
* Participation in regular meditation or a mindfulness program in past 3 months
18 Years
ALL
No
Sponsors
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Harvard University
OTHER
Chapman University
OTHER
University of Southern California
OTHER
Responsible Party
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Carolee Winstein
Professor
Principal Investigators
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Carolee Winstein, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of Southern California
Los Angeles, California, United States
Countries
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Other Identifiers
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UP-20-00568-P2
Identifier Type: -
Identifier Source: org_study_id
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