StrokeNCT05029193
Effectiveness of Mindfulness After a Stroke
A study testing Langerian mindfulness in people with Stroke and Caregiver Burnout, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Caregiver Burnout
- What is being tested?
- Langerian mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe language impairments
- Participation in regular meditation or a mindfulness program in past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: Effectiveness of an Online Mindfulness Program for Stroke Survivors and Their Caregivers
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.
Read the 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.
- Conditions
- Stroke, Caregiver Burnout
- Being tested
- Langerian mindfulness
- Keywords
- mindfulness, rehabilitation, caregiver, attention to variability
- Medical subject headings
- Stroke, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Langerian mindfulnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors - Mindfulness intervention | Experimental | Participants who have had a stroke who are receiving the mindfulness intervention immediately after enrollment (no wait period). Receives: Behavioral: Langerian mindfulness |
| Stroke survivors - Waitlist control | No intervention | Participants who have had a stroke who are assigned to the waitlist. |
| Caregivers - Mindfulness intervention | Experimental | Participants caring for someone who have had a stroke and receiving the mindfulness intervention immediately after enrollment (no wait period). Receives: Behavioral: Langerian mindfulness |
| Caregivers - Waitlist control | No intervention | Participants caring for someone who have had a stroke assigned to the waitlist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
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.
Measured: 2 months
Change from baseline on NIH Toolbox Perceived Stress Survey (PSS)
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.
Measured: 2 months
Change from baseline on Single-item Sleep Quality Scale (SQS)
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).
Measured: 2 months
Secondary outcomes (4)
Change from baseline on Stroke-specific Quality of Life (SS-QOL)
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.
Measured: 2 months
Change from baseline on World Health Organization Quality of Life-BREF (WHOQOL-BREF)
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.
Measured: 2 months
Change from baseline on Zarit Burden Interview
The Zarit Burden Interview includes 22 questions about caregiver burden rated from 0 (never) to 4 (nearly always). Higher scores indicate higher perceived burden.
Measured: 2 months
change in the modified Ashworth Scale (elbow)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start13 Sep 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Chapman University
- Responsible party
- Principal investigator, Carolee Winstein, University of Southern California
- Investigators
- Carolee Winstein, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029193
- Sponsor's protocol ID
- UP-20-00568-P2
- Status last verified
- Jul 2025
- First submitted
- 19 Aug 2021
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to study protocol, statistical analysis plan and informed consent form on clinicaltrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Online Mindfulness Program for Stroke Survivors and Their Caregivers
- ClinicalTrials.gov ID
- NCT05029193
- Acronym / sponsor ID
- UP-20-00568-P2
- Conditions
- Stroke, Caregiver Burnout
- Keywords
- mindfulness, rehabilitation, caregiver, attention to variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Harvard University, Chapman University
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors - Mindfulness intervention | Experimental | Behavioral: Langerian mindfulnessParticipants who have had a stroke who are receiving the mindfulness intervention immediately after enrollment (no wait period). |
| Stroke survivors - Waitlist control | No intervention | –Participants who have had a stroke who are assigned to the waitlist. |
| Caregivers - Mindfulness intervention | Experimental | Behavioral: Langerian mindfulnessParticipants caring for someone who have had a stroke and receiving the mindfulness intervention immediately after enrollment (no wait period). |
| Caregivers - Waitlist control | No intervention | –Participants caring for someone who have had a stroke assigned to the waitlist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Severe language impairments
- Participation in regular meditation or a mindfulness program in past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Langerian mindfulnessA 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. | Behavioural | Caregivers - Mindfulness intervention, Stroke survivors - Mindfulness intervention |
Primary outcome
Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
Time frame: 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 NIH Toolbox Perceived Stress Survey (PSS)
Time frame: 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.
Change from baseline on Single-item Sleep Quality Scale (SQS)
Time frame: 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).
4 secondary outcomes
Change from baseline on Stroke-specific Quality of Life (SS-QOL)
Time frame: 2 months
Change from baseline on World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: 2 months
Change from baseline on Zarit Burden Interview
Time frame: 2 months
change in the modified Ashworth Scale (elbow)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Yes. We plan to study protocol, statistical analysis plan and informed consent form on clinicaltrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolee Winstein, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Langerian mindfulness in people with Stroke and Caregiver Burnout, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the Hospital Anxiety and Depression Scale (HADS) (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.