StrokeNCT03473054
Stroke Survivors and Caregivers Using an Online Mindfulness-based Intervention Together
An observational study of Stroke and Cerebrovascular Accident, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebrovascular Accident, Stress
- What is being tested?
- Web-based Mindfulness Course
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Nov 2018to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
- 18yrs plus
- Based in Scotland
- Community-dwelling
- Able to use internet
- Access to internet
- Computer literate
- Able to communicate in written and spoken English
- Self-identifies as stressed/anxious/depressed.
Stroke Survivor Exclusion:
- Cognitive impairment
- Severe mental health problem
- Suicidal
- Significant drug/alcohol problems
- Currently using MBI
- Attending for other Psychosocial Intervention
- Difficulty eating
Family Caregiver Inclusion:
- Family caregiver to the stroke survivor
- 18yrs plus
- Based in Scotland
- Able to use the internet
- Access to internet
- Computer literate
- Able to communicate in written and spoken English
Family Caregiver Exclusion:
- Cognitive impairment
- Severe mental health problems
- Suicidal
- Significant drug/alcohol problems
- Currently using MBI
- Attending for other Psychosocial Intervention
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Caledonian University
Glasgow, Glasgow (City Of), G4 0BA
About this study
Official title: Evaluating the Therapeutic Effects for Stroke Survivors and Their Family-caregivers Using an Online Mindfulness-based Intervention Together
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.
Read the detailed description
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.
- Conditions
- Stroke, Cerebrovascular Accident, Stress, Anxiety, Depression
- Being tested
- Web-based Mindfulness Course
- Keywords
- Stroke, Cerebrovascular Accident, Stress, Anxiety, Depression, Mindfulness, Family caregivers, Web-based
- Medical subject headings
- Stroke, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Mindfulness CourseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based Mindfulness Course | 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. Receives: Other: Web-based Mindfulness Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0, 4, 8
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 0, 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start19 Nov 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maggie Lawrence, PhD, Study director, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473054
- Sponsor's protocol ID
- 200212862
- Status last verified
- Apr 2019
- First submitted
- 7 Mar 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Atteih S, Mellon L, Hall P, Brewer L, Horgan F, Williams D, Hickey A; ASPIRE-S study group. Implications of stroke for caregiver outcomes: findings from the ASPIRE-S study. Int J Stroke. 2015 Aug;10(6):918-23. doi: 10.1111/ijs.12535. Epub 2015 Jun 9.
PubMed 26061711Bakas T, McCarthy M, Miller ET. Update on the State of the Evidence for Stroke Family Caregiver and Dyad Interventions. Stroke. 2017 May;48(5):e122-e125. doi: 10.1161/STROKEAHA.117.016052. Epub 2017 Mar 28. No abstract available.
PubMed 28351961Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Elliott R, Slatick E, Urman M. Qualitative change process research on psychotherapy: Alternative strategies. Psychological Test and Assessment Modeling. 2001 Jan 1;43(3):69.
Kabat-Zinn J, Hanh TN. Full catastrophe living: Using the wisdom of your body and mind to face stress, pain, and illness. Delta; 2009 Jul 22.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
PubMed 10965637Wahbeh H, Svalina MN, Oken BS. Group, One-on-One, or Internet? Preferences for Mindfulness Meditation Delivery Format and their Predictors. Open Med J. 2014;1:66-74. doi: 10.2174/1874220301401010066. Epub 2014 Nov 28.
PubMed 27057260Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Res Nurs Health. 1990 Dec;13(6):375-84. doi: 10.1002/nur.4770130605.
PubMed 2270302Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Therapeutic Effects for Stroke Survivors and Their Family-caregivers Using an Online Mindfulness-based Intervention Together
- ClinicalTrials.gov ID
- NCT03473054
- Acronym / sponsor ID
- 200212862
- Conditions
- Stroke, Cerebrovascular Accident, Stress, Anxiety, Depression
- Keywords
- Stroke, Cerebrovascular Accident, Stress, Anxiety, Depression, Mindfulness, Family caregivers, Web-based
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based Mindfulness Course | – | Other: Web-based Mindfulness CourseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Mindfulness CourseThe 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. | Other | Web-based Mindfulness Course |
Primary outcome
Hospital Anxiety Depression Scale (Zigmond and Snaith, 1983): to assess change
Time frame: Weeks 0, 4, 8
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.
5 secondary outcomes
The Generalised Anxiety Disorder (Spitzer, et al. 2006): to assess change
Time frame: Week 0, 4
The Patient Health Questionnaire (Kroenke, Spitzer, & Williams, 2001): to assess change
Time frame: Weeks 0, 4
Perceived Stress Scale [PSS] (Cohen, Kamarck, and Mermelstein, 1994): to assess change
Time frame: Week 0, 4
Mindfulness Attention Awareness Scale [MAAS] (Brown and Ryan, 2003): to assess change
Time frame: Weeks 0, 4, 8
Mutuality Scale (MS) (Archbold, et al. 1990): to assess change
Time frame: Weeks 0, 4, 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Background: PubMed 26061711Atteih S, Mellon L, Hall P, Brewer L, Horgan F, Williams D, Hickey A; ASPIRE-S study group. Implications of stroke for caregiver outcomes: findings from the ASPIRE-S study. Int J Stroke. 2015 Aug;10(6):918-23. doi: 10.1111/ijs.12535. Epub 2015 Jun 9.
- Background: PubMed 28351961Bakas T, McCarthy M, Miller ET. Update on the State of the Evidence for Stroke Family Caregiver and Dyad Interventions. Stroke. 2017 May;48(5):e122-e125. doi: 10.1161/STROKEAHA.117.016052. Epub 2017 Mar 28. No abstract available.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundElliott R, Slatick E, Urman M. Qualitative change process research on psychotherapy: Alternative strategies. Psychological Test and Assessment Modeling. 2001 Jan 1;43(3):69.
- BackgroundKabat-Zinn J, Hanh TN. Full catastrophe living: Using the wisdom of your body and mind to face stress, pain, and illness. Delta; 2009 Jul 22.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 10965637Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
- Background: PubMed 27057260Wahbeh H, Svalina MN, Oken BS. Group, One-on-One, or Internet? Preferences for Mindfulness Meditation Delivery Format and their Predictors. Open Med J. 2014;1:66-74. doi: 10.2174/1874220301401010066. Epub 2014 Nov 28.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 2270302Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Res Nurs Health. 1990 Dec;13(6):375-84. doi: 10.1002/nur.4770130605.
- Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie Lawrence, PhD study director
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cerebrovascular Accident, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety Depression Scale (Zigmond and Snaith, 1983): to assess change (time frame: Weeks 0, 4, 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473054, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.