Stroke Survivors and Caregivers Using an Online Mindfulness-based Intervention Together

NCT03473054 | Completed

• 1 other identifier: 200212862
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Accident; Stress; Anxiety; Depression

Keywords

Stroke; Cerebrovascular Accident; Stress; Anxiety; Depression; Mindfulness; Family caregivers; Web-based

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 0, 4, 8

Secondary Outcomes (5)

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

  Week 0, 4

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

  Weeks 0, 4

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

  Week 0, 4

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

  Weeks 0, 4, 8

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

  Weeks 0, 4, 8

Study Arms (1)

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.

Other: Web-based Mindfulness Course

Interventions

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.

Web-based Mindfulness Course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Stroke survivor
• yrs 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.

You may not qualify if:

• Cognitive impairment
• Severe mental health problem
• Suicidal
• Significant drug/alcohol problems
• Currently using MBI
• Attending for other Psychosocial Intervention
• Difficulty eating
• Family caregiver to the stroke survivor
• yrs plus
• Based in Scotland
• Able to use the internet
• Access to internet
• Computer literate
• Able to communicate in written and spoken English
• Cognitive impairment

Sponsors & Collaborators

• Glasgow Caledonian University: lead

Study Sites (1)

Glasgow Caledonian University

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

Location

Related Publications (12)

• 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.

  PMID: 26061711 BACKGROUND

• 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.

  PMID: 28351961 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• Spitzer 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.

  PMID: 16717171 BACKGROUND

• 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. doi: 10.1037//0022-006x.68.4.615.

  PMID: 10965637 BACKGROUND

• 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. doi: 10.2174/1874220301401010066. Epub 2014 Nov 28.

  PMID: 27057260 BACKGROUND

• Zigmond 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.

  PMID: 6880820 BACKGROUND

• Archbold 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.

  PMID: 2270302 BACKGROUND

• Brown 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.

  PMID: 12703651 BACKGROUND

MeSH Terms

Conditions

Stroke; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Maggie Lawrence, PhD

  Glasgow Caledonian University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 22, 2018
• Study Start: November 19, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

GB (1)