Skip to main content
OpenTrials
Completed

NCT Number: NCT04553679

Mindfulness After Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Caregiver Burden Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stress, Psychological Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Southern California

Los Angeles, California, 90089, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mindfulness online intervention

Behavioral

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.

Primary outcomes

  1. Change in Stroke Impact Scale

    Time frame: from baseline to 3 weeks

    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).

Secondary outcomes

  1. Change in Hospital Anxiety and Depression Scale

    Time frame: from baseline to 3 weeks

    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).

  2. Change in National Institute of Health Perceived Stress Survey

    Time frame: from baseline to 3 weeks

    10-item self-reported measure assessing perceived stress. Scores range from 10 to 50, with higher scores indicating greater levels of perceived stress.

  3. Change in Single-Item Sleep Quality Scale

    Time frame: from baseline to 3 weeks

    1-item sleep quality scale ranging from 1 to 10. Higher scores indicate better sleep quality.

  4. Change in World Health Organization Quality of Life-bref

    Time frame: from baseline to 3 weeks

    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.

  5. Adapted Post-Study System Usability Questionnaire

    Time frame: 3 weeks

    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.

  6. Change in Zarit Burden Interview

    Time frame: from baseline to 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2020
Registry last updated
Feb 22, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.