Stroke Clinical Trial
Official title:
The Feasibility of Online Mindfulness for Stroke Sufferers
Verified date | December 2023 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A feasibility study to investigate the effect of an online mindfulness programme (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | First Community Health and Care (FCHC) | Caterham | Surrey |
Lead Sponsor | Collaborator |
---|---|
University of Surrey | First Community Health and Care, Surrey and Borders Partnership NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | Pre and Post Intervention, and at 3 and 6 months post-intervention follow up. | |
Secondary | 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) | Pre and Post Intervention, and at 3 and 6 months post-intervention follow up. | |
Secondary | 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) | Pre and Post Intervention, and at 3 and 6 months post-intervention follow up. | |
Secondary | 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. | Pre and Post Intervention, and at 3 and 6 months post-intervention follow up. | |
Secondary | 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. | Pre and Post Intervention, and at 3 and 6 months post-intervention follow up. | |
Secondary | 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. |
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up. | |
Secondary | 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'). | Pre and Post Intervention, and at 3 and 6 months post-intervention follow up. |
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