- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368950
Online Mindfulness for Stroke Sufferers
The Feasibility of Online Mindfulness for Stroke Sufferers
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Surrey
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Caterham, Surrey, United Kingdom
- First Community Health and Care (FCHC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participants in this arm are invited to undertake an 8-week online mindfulness course
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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.
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Active Comparator: Wait list
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).
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change to Stress Scale Score
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Perceived Stress Scale (PSS) Questionnaire (scores range from 0-40 with a higher score indicating higher and therefore worsened stress levels)
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Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change to Anxiety Measure Score
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
|
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)
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Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Change to Depression Measure Score
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Patient Health Questionnaire (PHQ9) Questionnaire consisting of 9 items (scores range from 0-27 with a higher score indicating worsened depression symptomatology)
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Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Change to Mindfulness Measure Score
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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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.
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Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Change to Worry and Rumination Measure Score
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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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.
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Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Change to Health Status Measure
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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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. |
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Change to Stroke Specific Quality of Life Measure
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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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').
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Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Chris Fife-Schaw, Professor, University of Surrey, Project Supervisor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPON/2017/03/FHMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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