Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-28 @ 5:12 PM
Study NCT ID:
NCT03368950
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2017-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online Mindfulness for Stroke Sufferers
Sponsor:
University of Surrey
Organization:
Study Overview
Official Title:
The Feasibility of Online Mindfulness for Stroke Sufferers
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A feasibility study to investigate the effect of an online mindfulness programme (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing.
Detailed Description:
Anxiety and depression is common to those post-stroke with about a third of stroke sufferers experiencing one or both. It is felt these are currently underdiagnosed and undertreated. There is a call for more accessible interventions. Mindfulness based interventions have shown considerable efficacy in treating anxiety and depression and there is growing body of evidence of the benefits of mindfulness for those post-stroke. This study will be the first to look at an instructor-led online mindfulness intervention for stroke sufferers. As a feasibility study it aims to investigate whether such an intervention is acceptable to patients and if so, can a larger scale study be done. The larger scale study will investigate whether the intervention is beneficial in reducing anxiety and depression. This study will assess the design and intervention format required to test this. Those who have had a stroke and are eligible to participate in the online mindfulness course will be invited to take part by their stroke specialist nurse. The 10 session course teaches participants mindfulness skills through audio and visual clips. Each week participants will be asked to complete one of each as well as do an informal exercise in their own time. It will take approximately 6-8 weeks to complete the course. The study will collect information from participants via online questionnaires before starting, during and at the end of the course. The questionnaires will ask about anxiety, depression, thinking style, health, quality of life and perceived stress levels. The investigators will not evaluate the outcomes but instead look at response rates and calculate standard deviations of the measures used to help us calculate the sample size needed for the larger study. The investigators will also look at the willingness of clinicians to recruit participants. Additionally, the study will involve interviews with a subset of participants to assess their experience of the study design and to explore the acceptability of the online mindfulness intervention in this population.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: