StrokeNCT03368950
Online Mindfulness for Stroke Sufferers
A study testing Online Mindfulness Course in people with Stroke, run by University of Surrey at 1 site in United Kingdom.
Trial summary
A feasibility study to investigate the effect of an online mindfulness programme (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Online Mindfulness Course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 1 Sep 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- More than 4 months post-stroke, when physical and social recovery will have stabilised and likely longer term problems can be assessed
- Those who express an interest in being involved in a study for those with emotional changes following stroke
- Have internet access at home or on tablet or smartphone, with access to speakers or headphones
- Are able to commit to two hours (minimum) per week for the duration of the course (6-8 weeks)
- Are able to understand the research materials.
Who cannot join
- Under 18 years old, to exclude childhood stroke (predominantly caused by congenital heart disease or sickle cell disease, whereas adult stroke is predominantly caused by atherosclerosis).
- Receiving another psychological intervention or mindfulness training at the time of study
- Actively psychotic, having received a diagnosis of dementia or a learning disability
- Severe mental health difficulties based on judgement of referring clinician
- Significant cognitive difficulties which would impact ability to access intervention despite prompting and support.
- Unable to read or understand English
- Without an email address or access to trusted family members email address
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
First Community Health and Care (FCHC)
Caterham, Surrey
About this study
Official title: The Feasibility of Online Mindfulness for Stroke Sufferers
A feasibility study to investigate the effect of an online mindfulness programme (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing.
Read the detailed description
Anxiety and depression is common to those post-stroke with about a third of stroke sufferers experiencing one or both. It is felt these are currently underdiagnosed and undertreated. There is a call for more accessible interventions. Mindfulness based interventions have shown considerable efficacy in treating anxiety and depression and there is growing body of evidence of the benefits of mindfulness for those post-stroke. This study will be the first to look at an instructor-led online mindfulness intervention for stroke sufferers. As a feasibility study it aims to investigate whether such an intervention is acceptable to patients and if so, can a larger scale study be done. The larger scale study will investigate whether the intervention is beneficial in reducing anxiety and depression. This study will assess the design and intervention format required to test this. Those who have had a stroke and are eligible to participate in the online mindfulness course will be invited to take part by their stroke specialist nurse. The 10 session course teaches participants mindfulness skills through audio and visual clips. Each week participants will be asked to complete one of each as well as do an informal exercise in their own time. It will take approximately 6-8 weeks to complete the course. The study will collect information from participants via online questionnaires before starting, during and at the end of the course. The questionnaires will ask about anxiety, depression, thinking style, health, quality of life and perceived stress levels. The investigators will not evaluate the outcomes but instead look at response rates and calculate standard deviations of the measures used to help us calculate the sample size needed for the larger study. The investigators will also look at the willingness of clinicians to recruit participants. Additionally, the study will involve interviews with a subset of participants to assess their experience of the study design and to explore the acceptability of the online mindfulness intervention in this population.
- Conditions
- Stroke
- Being tested
- Online Mindfulness Course
- Keywords
- Anxiety, Depression, Stress
- Medical subject headings
- Stroke, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness CourseOther
An online mindfulness course guiding participants through all elements of Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR). Ten easy-to-follow sessions with videos and interactive exercises led by leading mindfulness trainers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this arm are invited to undertake an 8-week online mindfulness course Receives: Other: Online Mindfulness Course |
| Wait list | Active comparator | Participants in this arm are informed they are on a wait list and are required to wait 8 weeks, before being invited to take part in the intervention itself (an 8-week online mindfulness course). Receives: Other: Online Mindfulness Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change to Stress Scale Score
Perceived Stress Scale (PSS) Questionnaire (scores range from 0-40 with a higher score indicating higher and therefore worsened stress levels)
Measured: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Secondary outcomes (6)
Change to Anxiety Measure Score
Generalised Anxiety Disorder (GAD7) Questionnaire consisting of 7 items (scores range from 0-21 with a higher score indicating higher and therefore worsened anxiety levels)
Measured: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Depression Measure Score
Patient Health Questionnaire (PHQ9) Questionnaire consisting of 9 items (scores range from 0-27 with a higher score indicating worsened depression symptomatology)
Measured: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Mindfulness Measure Score
Five Facet Mindfulness Questionnaire - Short form - Questionnaire produces a total score and 5 subtest scores for different facets of mindfulness: Observing, Describing, Acting with Awareness, Non-Judging of inner experience, and Non-Reactivity to inner experience from 15 items. A higher score indicates greater (and therefore better) self-reported level of mindfulness skills.
Measured: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Worry and Rumination Measure Score
Perseverative Thinking Questionnaire (PTQ) consisting of 15 items (scores range from 0-60 with a higher score indicating a higher level of, and therefore worsened perseverative and ruminative thinking.
Measured: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Health Status Measure
EQ5DL Questionnaire consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A chosen health state is indicated by ticking the box next to the most appropriate statement resulting in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state (with a lower score indicating no health issues i.e. better health).
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. Scores range from 0-100 with a higher score indicating better health.
Measured: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Stroke Specific Quality of Life Measure
Stroke Specific Quality of Life 12-item Scale consists of 12 domains relating to: energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work/productivity. Participants indicate how much their stroke has negatively impacted their functioning in each domain (with answers ranging from 'couldn't do it at all' to 'no trouble at all', strongly agree/disagree, 'total help' to 'no help needed').
Measured: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
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
- Parallel groups
- Model description
- Randomised Wait list or Intervention Arms
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- First Community Health and Care, Surrey and Borders Partnership NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Chris Fife-Schaw, Professor, Study chair, University of Surrey, Project Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368950
- Sponsor's protocol ID
- SPON/2017/03/FHMS
- Status last verified
- Dec 2023
- First submitted
- 11 Oct 2017
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Online Mindfulness for Stroke Sufferers
- ClinicalTrials.gov ID
- NCT03368950
- Acronym / sponsor ID
- SPON/2017/03/FHMS
- Conditions
- Stroke
- Keywords
- Anxiety, Depression, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- First Community Health and Care, Surrey and Borders Partnership NHS Foundation Trust
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 11 Dec 2017 (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.
A feasibility study to investigate the effect of an online mindfulness programme (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing.
Detailed description
Anxiety and depression is common to those post-stroke with about a third of stroke sufferers experiencing one or both. It is felt these are currently underdiagnosed and undertreated. There is a call for more accessible interventions. Mindfulness based interventions have shown considerable efficacy in treating anxiety and depression and there is growing body of evidence of the benefits of mindfulness for those post-stroke. This study will be the first to look at an instructor-led online mindfulness intervention for stroke sufferers. As a feasibility study it aims to investigate whether such an intervention is acceptable to patients and if so, can a larger scale study be done. The larger scale study will investigate whether the intervention is beneficial in reducing anxiety and depression. This study will assess the design and intervention format required to test this. Those who have had a stroke and are eligible to participate in the online mindfulness course will be invited to take part by their stroke specialist nurse. The 10 session course teaches participants mindfulness skills through audio and visual clips. Each week participants will be asked to complete one of each as well as do an informal exercise in their own time. It will take approximately 6-8 weeks to complete the course. The study will collect information from participants via online questionnaires before starting, during and at the end of the course. The questionnaires will ask about anxiety, depression, thinking style, health, quality of life and perceived stress levels. The investigators will not evaluate the outcomes but instead look at response rates and calculate standard deviations of the measures used to help us calculate the sample size needed for the larger study. The investigators will also look at the willingness of clinicians to recruit participants. Additionally, the study will involve interviews with a subset of participants to assess their experience of the study design and to explore the acceptability of the online mindfulness intervention in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Wait list or Intervention Arms
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Online Mindfulness CourseParticipants in this arm are invited to undertake an 8-week online mindfulness course |
| Wait list | Active comparator | Other: Online Mindfulness CourseParticipants in this arm are informed they are on a wait list and are required to wait 8 weeks, before being invited to take part in the intervention itself (an 8-week online mindfulness course). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- More than 4 months post-stroke, when physical and social recovery will have stabilised and likely longer term problems can be assessed
- Those who express an interest in being involved in a study for those with emotional changes following stroke
- Have internet access at home or on tablet or smartphone, with access to speakers or headphones
- Are able to commit to two hours (minimum) per week for the duration of the course (6-8 weeks)
- Are able to understand the research materials.
Key exclusion criteria (7 listed)
- Under 18 years old, to exclude childhood stroke (predominantly caused by congenital heart disease or sickle cell disease, whereas adult stroke is predominantly caused by atherosclerosis).
- Receiving another psychological intervention or mindfulness training at the time of study
- Actively psychotic, having received a diagnosis of dementia or a learning disability
- Severe mental health difficulties based on judgement of referring clinician
- Significant cognitive difficulties which would impact ability to access intervention despite prompting and support.
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 |
|---|---|---|
| Online Mindfulness CourseAn online mindfulness course guiding participants through all elements of Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR). Ten easy-to-follow sessions with videos and interactive exercises led by leading mindfulness trainers. | Other | Intervention, Wait list |
Primary outcome
Change to Stress Scale Score
Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Perceived Stress Scale (PSS) Questionnaire (scores range from 0-40 with a higher score indicating higher and therefore worsened stress levels)
6 secondary outcomes
Change to Anxiety Measure Score
Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Depression Measure Score
Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Mindfulness Measure Score
Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Worry and Rumination Measure Score
Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Health Status Measure
Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Stroke Specific Quality of Life Measure
Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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 22 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Chris Fife-Schaw, Professor study chair
University of Surrey, Project Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness Course in people with Stroke, run by University of Surrey at 1 site in United Kingdom.
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 5 inclusion and 7 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 22 Dec 2023. 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 Kingdom. 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 to Stress Scale Score (time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.). 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 22 Dec 2023.