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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03473054
Other study ID # 200212862
Secondary ID
Status Not yet recruiting
Phase
First received March 7, 2018
Last updated March 14, 2018
Start date September 2018
Est. completion date September 2019

Study information

Verified date March 2018
Source Glasgow Caledonian University
Contact Ben Parkinson, MSc
Phone 0141 331 3114
Email ben.parkinson@gcu.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date September 2019
Est. primary completion date February 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United Kingdom Glasgow Caledonian University Glasgow Glasgow (City Of)

Sponsors (1)

Lead Sponsor Collaborator
Glasgow Caledonian University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

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. — View Citation

Bakas 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. Review. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

Elliott 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. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Teasdale 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. — View Citation

Wahbeh 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. Epub 2014 Nov 28. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Anxiety Depression Scale (Zigmond and Snaith, 1983) 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. Change measure: baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10.
Primary The Change Interview (Elliott, Slatick, and Urman, 2001). A dyadic semi-structured qualitative interview will be completed with the stroke survivor and family caregiver together at a the end of the study. The interview will take about 60-90 minutes and will explore the feasibility, appropriateness, meaningfulness, and clinical effectiveness of the intervention. Week 10
Secondary The Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983). A self-report 14-item instrument for measuring the degree of perceived stress. Individual scores range between 0 and 40 with higher scores indicating higher stress (e.g. 0-13 low stress, 14-26 moderate stress, and 27-40 high stress). Week 2
Secondary The Perceived Stress Scale (Cohen, Kamarck, & Mermelstein, 1983). A self-report 14-item instrument for measuring the degree of perceived stress. Individual scores range between 0 and 40 with higher scores indicating higher stress (e.g. 0-13 low stress, 14-26 moderate stress, and 27-40 high stress). Week 6
Secondary The Generalised Anxiety Disorder (Spitzer, et al. 2006) 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. Week 2
Secondary The Generalised Anxiety Disorder (Spitzer, et al. 2006) 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. Week 6
Secondary The Patient Health Questionnaire (Kroenke, Spitzer, & Williams, 2001) 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. Weeks 2
Secondary The Patient Health Questionnaire (Kroenke, Spitzer, & Williams, 2001) 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. Weeks 6
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