Online Mindfulness for Stroke Sufferers
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Online Mindfulness Course
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Anxiety, Depression, Stress
Eligibility Criteria
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
Sites / Locations
- First Community Health and Care (FCHC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Wait list
Arm Description
Participants in this arm are invited to undertake an 8-week online mindfulness course
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).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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.
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.
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.
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').
Full Information
NCT ID
NCT03368950
First Posted
October 11, 2017
Last Updated
February 13, 2018
Sponsor
University of Surrey
Collaborators
First Community Health and Care, Surrey and Borders Partnership NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03368950
Brief Title
Online Mindfulness for Stroke Sufferers
Official Title
The Feasibility of Online Mindfulness for Stroke Sufferers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey
Collaborators
First Community Health and Care, Surrey and Borders Partnership NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Anxiety, Depression, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Wait list or Intervention Arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in this arm are invited to undertake an 8-week online mindfulness course
Arm Title
Wait list
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Online Mindfulness Course
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change to Stress Scale Score
Description
Perceived Stress Scale (PSS) Questionnaire (scores range from 0-40 with a higher score indicating higher and therefore worsened stress levels)
Time Frame
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Secondary Outcome Measure Information:
Title
Change to Anxiety Measure Score
Description
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)
Time Frame
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Title
Change to Depression Measure Score
Description
Patient Health Questionnaire (PHQ9) Questionnaire consisting of 9 items (scores range from 0-27 with a higher score indicating worsened depression symptomatology)
Time Frame
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Title
Change to Mindfulness Measure Score
Description
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.
Time Frame
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Title
Change to Worry and Rumination Measure Score
Description
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.
Time Frame
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Title
Change to Health Status Measure
Description
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.
Time Frame
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Title
Change to Stroke Specific Quality of Life Measure
Description
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').
Time Frame
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Fife-Schaw, Professor
Organizational Affiliation
University of Surrey, Project Supervisor
Official's Role
Study Chair
Facility Information:
Facility Name
First Community Health and Care (FCHC)
City
Surrey
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Online Mindfulness for Stroke Sufferers
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