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Online Mindfulness for Stroke Sufferers

NCT ID: NCT03368950

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-09-01

Brief Summary

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A feasibility study to investigate the effect of an online mindfulness programme (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing.

Detailed Description

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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

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Stroke

Keywords

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Anxiety Depression Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Wait list or Intervention Arms
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Participants in this arm are invited to undertake an 8-week online mindfulness course

Group Type EXPERIMENTAL

Online Mindfulness Course

Intervention Type OTHER

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.

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).

Group Type ACTIVE_COMPARATOR

Online Mindfulness Course

Intervention Type OTHER

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.

Interventions

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Online Mindfulness Course

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Community Health and Care

UNKNOWN

Sponsor Role collaborator

Surrey and Borders Partnership NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Surrey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Fife-Schaw, Professor

Role: STUDY_CHAIR

University of Surrey, Project Supervisor

Locations

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First Community Health and Care (FCHC)

Caterham, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SPON/2017/03/FHMS

Identifier Type: -

Identifier Source: org_study_id