Online Mindfulness for Stroke Sufferers

December 18, 2023 updated by: University of Surrey

The Feasibility of Online Mindfulness for Stroke Sufferers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Caterham, Surrey, United Kingdom
        • First Community Health and Care (FCHC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants in this arm are invited to undertake an 8-week online mindfulness course
Other: 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.
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).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
Change to Depression Measure Score
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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.
Change to Mindfulness Measure Score
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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.
Change to Worry and Rumination Measure Score
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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.
Change to Health Status Measure
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

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.
Change to Stroke Specific Quality of Life Measure
Time Frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Surrey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Surrey and Borders Partnership NHS Foundation Trust
First Community Health and Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chris Fife-Schaw, Professor, University of Surrey, Project Supervisor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPON/2017/03/FHMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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