An observational study in Stroke, Cerebrovascular Accident and Stress, sponsored by Glasgow Caledonian University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-26.
Sponsored by Glasgow Caledonian University · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 11 studies in Stroke by Glasgow Caledonian University — 2 open to participants now, 2 under way, none of them phase 3. Stroke · Glasgow Caledonian University.
Among the 11 studies in Stroke by Glasgow Caledonian University, this one is the only one that started in 2018, is the only observational one, and was the 4th registered.
8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.
Browse Stroke studies →2 of the 11 studies in Stroke by Glasgow Caledonian University are open now, in 1 country. Recruiting first, the newest first:
Glasgow Caledonian University · Sites in United Kingdom
Ages 16+
Glasgow Caledonian University
Ages 18+
By country, each count listing its studies:
Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2018.
This study's enrollment of 10 is below the median of 152 across 1,968 observational studies indexed under Stroke.
Median enrollment 49 across the 10 interventional studies, 10 across the 1 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Glasgow Caledonian University is the lead sponsor of 46 studies on the registry; 3 are open to participants now.
2 of the studies in Stroke by Glasgow Caledonian University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06871878Glasgow Caledonian UniversityFeasibility of a Physiotherapy Programme, With Integrated telerehabIlitation to Increase Rehabilitation Time and Improve Motor Function | 2027-07-10 |
| NCT07752563Glasgow Caledonian UniversityPilot RCT of Computer-based Eye Movement Training | 2027-07-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies in Stroke by Glasgow Caledonian University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Stroke survivors and their family caregivers often experience stress, anxiety, and depression. The psychological wellbeing of stroke survivors and family caregivers is thought to be interconnected and can have an important role to play in rehabilitation outcomes. Mindfulness meditation can help improve psychological wellbeing, but it often involves people attending groups by themselves and engagement can be poor. One solution is for stroke survivors and family caregivers to learn mindfulness meditation together online.
This study aims to explore the feasibility, appropriateness, meaningfulness, and effectiveness of mindfulness meditation delivered online for stroke survivor and family caregiver partnerships.
Introduction Stroke survivors and their family caregivers often experience stress, anxiety, and depression. Research suggests the emotional wellbeing of the stroke survivor and family caregiver might be interconnected, which means optimum outcomes will only be achieved when they are supported as a partnership (Atteih, et al. 2015).
Mindfulness-Based Interventions (MBIs) can help psychological wellbeing, but usually involve people attending groups by themselves, which might not suit everyone. Sometimes accessing group-based MBI can be difficult and/or people might not want to learn MBI within a group environment (Wahbeh, et al. 2014). Web-based MBIs have become more readily available in recent years, but little attention has been given to partnership orientated web-based interventions. Research is needed to explore the potential effects of web-based MBI for stroke survivors and family caregiver partnerships (Bakas, et al. 2017). This study aims to explore the feasibility, appropriateness, meaningfulness, and effectiveness of web-based MBIs for stroke survivor and family caregiver partnerships.
Method Purposive sampling will be used to recruit community-dwelling stroke survivor-family caregiver partnerships (n=5 dyads). These partnerships will complete a four-week asynchronous tutor-led web-based MBI. The web-based MBI aligns with the eight-week Mindfulness-Based Stress Reduction (Kabat-Zinn and Hanh, 2009) and Mindfulness-Based Cognitive Therapy (Teasedale, et al. 2000) courses, but in a shorter format. The course involves ten online interactive videos (30 minutes each), twelve daily practice assignments (with supportive emails), five audio downloads, and online tools for reviewing progress.
The design will involve a mixed method multiple single-case (A-B) design: two-week baseline, four-week intervention, and four-week follow-up phases. Stroke survivors and family caregivers will complete the Hospital Anxiety Depression Scale (HADS) (Zigmond and Snaith, 1983) weekly to evaluate psychological wellbeing and clinical effectiveness. Paired semi-structured post-intervention interviews will be completed at follow-up and Interpretative Phenomenological Analysis used to contextualize the results and explain the meaning associated with the findings.
Results Recruitment and completion data will be reported using descriptive statistics to help evaluate feasibility and appropriateness. HADS outcome data for stroke survivors and family caregivers will be presented in individual graphs and using raw data to facilitate future meta-analysis. Visual and statistical analysis of outcome data will be completed to evaluate clinical effectiveness, effect size, and whether any changes were statistically significant.
The Interpretative Phenomenological Analysis will be reported using relevant themes and participants' quotes to provide a coherent analysis of the feasibility, appropriateness, meaningfulness, and effectiveness of stroke survivors and family caregivers using web-based MBI.
Discussion The findings will inform the feasibility, acceptability, and clinical effectiveness of web-based MBI for stroke survivors and family caregivers partnerships. The study will explore the usefulness and meaning of learning MBI online and in a partnership. These findings could help determine whether using web-based MBI in a partnership has any therapeutic value for participants and help tailor such intervention for stroke survivor and family caregiver partnerships.
The study will use purposeful sampling and recruit community-dwelling adult stroke survivors and their family caregivers within Scotland. Stroke-survivors and family caregivers will be recruited together and participate as a partnership.
Stroke Survivor Inclusion:
Stroke Survivor Exclusion:
Family Caregiver Inclusion:
Family Caregiver Exclusion:
Participants will complete a 2 week baseline phase, followed by the four week web-based mindfulness course intervention phase, and a four week follow-up period.
Other: Web-based Mindfulness Course
The intervention is a therapist led, web-based MBI course, delivered asynchronously via a series of online videos. The Be Mindful course is a four-week mindfulness course based on the Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy courses. The course has been positively evaluated and shown to reduce stress, anxiety, and depression for participants. Participants complete ten online interactive videos (30 minutes each), twelve daily practice assignments (with supportive emails), five audio downloads, and online tools for reviewing progress. The minimum time to complete the course is four weeks, but people can take longer if they wish and will still have access to the resources.
Hospital Anxiety Depression Scale (Zigmond and Snaith, 1983): to assess change
The Hospital Anxiety and Depression Scale is a self-report measure, which consists of 14 questions and usually take 2-5 minutes to complete. The HADS has good validity for measuring anxiety and depression in both clinical and none clinical settings and is a good option for assessing both anxiety and depression concurrently with stroke survivors. The HADS provides useful cut-off scores to help screen for clinical levels (e.g. 8-10 mild, 11-14 moderate, and 15-21 severe) of anxiety and depression.
Time frame: Weeks 0, 4, 8
The Generalised Anxiety Disorder (Spitzer, et al. 2006): to assess change
The 7-item self-report measure is a valid and efficient tool for screening generalized anxiety disorder in clinical and research settings. The tool produces a score (0-21), with scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety.
Time frame: Week 0, 4
The Patient Health Questionnaire (Kroenke, Spitzer, & Williams, 2001): to assess change
The Patient Health Questionnaire is a self-administered 9-item brief diagnostic instrument for depression. The tool produces a total score (0-27), which is divided into the following categories of increasing severity: 0-4, 5-9, 10-14, 15-19, and 20 or greater.
Time frame: Weeks 0, 4
Perceived Stress Scale [PSS] (Cohen, Kamarck, and Mermelstein, 1994): to assess change
The Perceived Stress Scale (PSS) is a widely used psychological tool for measuring the perception of stress. It measures of the extent situations are appraised as stressful. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items.
Time frame: Week 0, 4
Mindfulness Attention Awareness Scale [MAAS] (Brown and Ryan, 2003): to assess change
The MAAS is a 15-item scale to assess mindfulness. The scale has strong psychometric properties and has been validated. The measure takes 10 minutes or less to complete. Higher scores reflect higher levels of dispositional mindfulness.
Time frame: Weeks 0, 4, 8
Mutuality Scale (MS) (Archbold, et al. 1990): to assess change
The MS is a 15-item tool that measures mutuality. It is scored using a 5-point Likert scale from 0 ( not at all ) to 4 ( a great deal ). The total scale score, a mean of all item scores, ranges from 0 to 4: higher scores means greater mutuality.
Time frame: Weeks 0, 4, 8
Plan to share: Yes — Anonymous Hospital Anxiety Depression Scale (HADS) outcome data will be shared via peer-reviewed journal publication and professional conferences after the study has been completed.
Supporting information: Study protocol
Time frame: Within future published work within peer reviewed academic journals and/or professional conferences.
Access criteria: Data access requests will be reviewed by the chief investigator and/or director of studies. Data will only be released on an anonymous basis and with participant consent.
Ran from Nov 2018 to primary completion in Aug 2019, 8 months.
Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's 8 months is below that.
Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Glasgow Caledonian University