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Completed

NCT Number: NCT03473054

Stroke Survivors and 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.

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Key information

Conditions

Stroke Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Depression Mental Disorders Nervous System Diseases Stress Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glasgow Caledonian University

Glasgow, Glasgow (City Of), G4 0BA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based Mindfulness Course

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The Generalised Anxiety Disorder (Spitzer, et al. 2006): to assess change

    Time frame: Week 0, 4

    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.

  2. The Patient Health Questionnaire (Kroenke, Spitzer, & Williams, 2001): to assess change

    Time frame: Weeks 0, 4

    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.

  3. Perceived Stress Scale [PSS] (Cohen, Kamarck, and Mermelstein, 1994): to assess change

    Time frame: Week 0, 4

    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.

  4. Mindfulness Attention Awareness Scale [MAAS] (Brown and Ryan, 2003): to assess change

    Time frame: Weeks 0, 4, 8

    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.

  5. Mutuality Scale (MS) (Archbold, et al. 1990): to assess change

    Time frame: Weeks 0, 4, 8

    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.

Sponsors and collaborators

Lead sponsor

Glasgow Caledonian University

Other

Registry information

Official study title

Evaluating the Therapeutic Effects for Stroke Survivors and Their Family-caregivers Using an Online Mindfulness-based Intervention Together

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2018
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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