Clinical trial NCT03473054: Stroke Survivors and Caregivers Using an Online Mindfulness-based Intervention Together
Official title: Evaluating the Therapeutic Effects for Stroke Survivors and Their Family-caregivers Using an Online Mindfulness-based Intervention Together
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Cerebrovascular Accident
Stress
Anxiety
Depression
Keywords: Stroke
Cerebrovascular Accident
Stress
Anxiety
Depression
Mindfulness
Family caregivers
Web-based
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Anxiety Depression Scale (Zigmond and Snaith, 1983): to assess change
timeFrame: Weeks 0, 4, 8
Secondary outcomes:
measure: The Generalised Anxiety Disorder (Spitzer, et al. 2006): to assess change
timeFrame: Week 0, 4
measure: The Patient Health Questionnaire (Kroenke, Spitzer, & Williams, 2001): to assess change
timeFrame: Weeks 0, 4
measure: Perceived Stress Scale [PSS] (Cohen, Kamarck, and Mermelstein, 1994): to assess change
timeFrame: Week 0, 4
measure: Mindfulness Attention Awareness Scale [MAAS] (Brown and Ryan, 2003): to assess change
timeFrame: Weeks 0, 4, 8
measure: Mutuality Scale (MS) (Archbold, et al. 1990): to assess change
timeFrame: Weeks 0, 4, 8
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Glasgow (City Of)
Study officials:
affiliation: Glasgow Caledonian University
name: Maggie Lawrence, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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. No abstract available.
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