Effectiveness of Mindfulness After a Stroke

University of Southern California

Status: Completed

Conditions: Stroke; Caregiver Burnout

Treatments: Behavioral: Langerian mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT05029193

UP-20-00568-P2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 4 patient groups

Stroke survivors - Mindfulness intervention

Experimental group

Description:

Participants who have had a stroke who are receiving the mindfulness intervention immediately after enrollment (no wait period).

Treatment:

Behavioral: Langerian mindfulness

Stroke survivors - Waitlist control

No Intervention group

Description:

Participants who have had a stroke who are assigned to the waitlist.

Caregivers - Mindfulness intervention

Experimental group

Description:

Participants caring for someone who have had a stroke and receiving the mindfulness intervention immediately after enrollment (no wait period).

Treatment:

Behavioral: Langerian mindfulness

Caregivers - Waitlist control

No Intervention group

Description:

Participants caring for someone who have had a stroke assigned to the waitlist.