Online Mindfulness for Stroke Sufferers

NCT03368950 | Completed

• 1 other identifier: SPON/2017/03/FHMS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility study to investigate the effect of an online mindfulness programme (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing.

Conditions

Stroke

Keywords

Anxiety; Depression; Stress

Outcome Measures

Primary Outcomes (1)

• Change to Stress Scale Score

  Perceived Stress Scale (PSS) Questionnaire (scores range from 0-40 with a higher score indicating higher and therefore worsened stress levels)

  Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

Secondary Outcomes (6)

• Change to Anxiety Measure Score

  Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

• Change to Depression Measure Score

  Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

• Change to Mindfulness Measure Score

  Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

• Change to Worry and Rumination Measure Score

  Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

• Change to Health Status Measure

  Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm are invited to undertake an 8-week online mindfulness course

Other: Online Mindfulness Course

Wait list

ACTIVE COMPARATOR

Participants in this arm are informed they are on a wait list and are required to wait 8 weeks, before being invited to take part in the intervention itself (an 8-week online mindfulness course).

Other: Online Mindfulness Course

Interventions

Online Mindfulness Course OTHER

An online mindfulness course guiding participants through all elements of Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR). Ten easy-to-follow sessions with videos and interactive exercises led by leading mindfulness trainers.

Intervention; Wait list

Eligibility Criteria

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

You may qualify if:

• More than 4 months post-stroke, when physical and social recovery will have stabilised and likely longer term problems can be assessed
• Those who express an interest in being involved in a study for those with emotional changes following stroke
• Have internet access at home or on tablet or smartphone, with access to speakers or headphones
• Are able to commit to two hours (minimum) per week for the duration of the course (6-8 weeks)
• Are able to understand the research materials.

You may not qualify if:

• Under 18 years old, to exclude childhood stroke (predominantly caused by congenital heart disease or sickle cell disease, whereas adult stroke is predominantly caused by atherosclerosis).
• Receiving another psychological intervention or mindfulness training at the time of study
• Actively psychotic, having received a diagnosis of dementia or a learning disability
• Severe mental health difficulties based on judgement of referring clinician
• Significant cognitive difficulties which would impact ability to access intervention despite prompting and support.
• Unable to read or understand English
• Without an email address or access to trusted family members email address

Sponsors & Collaborators

• University of Surrey: lead
• First Community Health and Care: collaborator
• Surrey and Borders Partnership NHS Foundation Trust: collaborator

Study Sites (1)

First Community Health and Care (FCHC)

Caterham, Surrey, United Kingdom

Location

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

• Chris Fife-Schaw, Professor

  University of Surrey, Project Supervisor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Wait list or Intervention Arms

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: December 11, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)