Clinical trial NCT03368950: Online Mindfulness for Stroke Sufferers
Official title: The Feasibility of Online Mindfulness for Stroke Sufferers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Anxiety
Depression
Stress
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: First Community Health and Care
name: Surrey and Borders Partnership NHS Foundation Trust
First posted: 2017-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Wait list or Intervention Arms
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change to Stress Scale Score
timeFrame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Secondary outcomes:
measure: Change to Anxiety Measure Score
timeFrame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
measure: Change to Depression Measure Score
timeFrame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
measure: Change to Mindfulness Measure Score
timeFrame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
measure: Change to Worry and Rumination Measure Score
timeFrame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
measure: Change to Health Status Measure
timeFrame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
measure: Change to Stroke Specific Quality of Life Measure
timeFrame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Other outcomes:
Locations:
city: Caterham
country: United Kingdom
facility: First Community Health and Care (FCHC)
state: Surrey
Study officials:
affiliation: University of Surrey, Project Supervisor
name: Chris Fife-Schaw, Professor
role: STUDY_CHAIR
References: