Mindfulness After Stroke

Stroke Clinical Trial

Official title:

Development of an Online Mindfulness Program for Stroke Survivors and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553679
• Other study ID #: UP-20-00568
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: May 2022
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test the relevance, satisfaction and ease-of-use of an online mindfulness intervention among stroke survivors and their caregivers. Quality of life, depression, anxiety, stress and sleep quality will be assessed before, after and at 1 month after the intervention. After the intervention, participants' feedback about the usability and the satisfaction with the intervention and the online program will be gathered. Based on participants' feedback, changes to the intervention will be made to obtain a final version.

Description:

The incidence of depression and anxiety is much higher in stroke survivors and their caregivers compared to age-matched peers. Previous work suggests that mindfulness delivered in an online format is promising for both individuals with neurological disorders and caregivers to improve quality of life and psychological well-being.

The overall objective of this project is to develop and refine an online mindfulness program that is perceived as relevant and user-friendly for stroke survivors and their caregivers. This project also aims to determine the potential impact of the mindfulness program on psychological well-being for stroke survivors and caregivers to guide the development of a future intervention study.

The process of development of the online mindfulness program will be iterative and will involve three phases: one development phase, one usability testing phase with end-users and one refinement phase.

Phase 1) The 3-week online mindfulness program will be adapted from the program developed for individuals with amyotrophic lateral sclerosis by mindfulness and stroke experts to ensure suitability and relevance for individuals with stroke.

Phase 2) A testing phase will be conducted remotely for both technical and clinical verification with 5-10 stroke survivors and 5-10 caregivers. Self-reported questionnaires about psychological well-being will be administered prior to and after the participation to the program and at a 1-month follow-up. After the program, a usability questionnaire and a semi-structured interview will be conducted to assess the usability of the mindfulness program and gather participants' feedback. For each group, differences prior to and after the mindfulness program will be assessed using a repeated measure analysis of variance. The transcribed verbatim of the semi-structured interview will be analyzed independently using thematic content analysis by 2 members of the research team.

Phase 3) Based on the results from Phase 2, modifications will be made to the online mindfulness program. If warranted, the testing phase will be replicated with a second cohort of participants.

This project will lead to the development of an online mindfulness program suitable for stroke survivors and their caregivers to improve quality of life and psychological well-being. This project will help guide the development of a planned intervention study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of stroke (for stroke survivors) or caregiver of someone who have had a stroke

• Ability to access Internet using a computer, a tablet and/or a smart phone

• Ability to provide informed consent

• Fluent in English

Exclusion Criteria:

• Severe language impairments

• Regular meditation or participation in a mindfulness program in the past 3 months

Related Conditions & MeSH terms

• Caregiver Burden
• Stroke

Intervention

Behavioral:
• Mindfulness online intervention
A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stroke Impact Scale	Quality of life and impact of stroke after the intervention. The Stroke Impact Scale is a 59-item measure and is divided in 8 domains. Scores range from 0-100 (with higher score showing better quality of life and lower stroke impact).	from baseline to 3 weeks
Secondary	Change in Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with 7 items each for anxiety and depression subscales. Each item is scored from 0 to 3, with higher scores indicating higher anxiety or depressive symptoms. Anxiety and depression with scores ranging from 0 (no depression/anxiety) to 21 (severe depressive/anxious symptoms).	from baseline to 3 weeks
Secondary	Change in National Institute of Health Perceived Stress Survey	10-item self-reported measure assessing perceived stress. Scores range from 10 to 50, with higher scores indicating greater levels of perceived stress.	from baseline to 3 weeks
Secondary	Change in Single-Item Sleep Quality Scale	1-item sleep quality scale ranging from 1 to 10. Higher scores indicate better sleep quality.	from baseline to 3 weeks
Secondary	Change in World Health Organization Quality of Life-bref	The World Health Organization Quality of Life-BREF (WHOQOL-BREF) comprises 26 questions from 4 domains about health and well-being: 1) Physical health (e.g., Activities of daily living, Mobility, Fatigue, etc.), 2) Psychological (e.g., Negative/positive feelings, Self-esteem, Spirituality, etc.), 3) Social relationships (e.g., Personal relationships, Social support, Sexual activity), 4) Environment (e.g., financial resources, home environment, opportunities for leisures, etc.). The scores are transformed on a scale from 0-100. Higher scores indicate better perceived health and well-being.; Outcome measure only administered to caregivers.	from baseline to 3 weeks
Secondary	Adapted Post-Study System Usability Questionnaire	The adapted Post-Study System Usability Questionnaire (PSSUQ) consists of 5 questions on perceived satisfaction with the online platform used to host the program. Each question is scored on a 7-point Likert scale from 1 (Strongly Agree) to 7 (Strongly Disagree) for a total score of 35. Higher scores indicate lower usability.	3 weeks
Secondary	Change in Zarit Burden Interview	The Zarit Burden Interview includes 22 questions about caregiver burden rated from 0 (never) to 4 (nearly always). Scores range from 0-88 with higher scores indicating greater burden.; Measure administered only to participants in the caregiver group.	from baseline to 3 weeks