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Mindfulness After Stroke

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ClinicalTrials.gov Identifier: NCT04553679
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Carolee Winstein, University of Southern California

Brief 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.

Condition or disease Intervention/treatment
Stroke Caregiver Burden Behavioral: Mindfulness online intervention

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of an Online Mindfulness Program for Stroke Survivors and Their Caregivers
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Change in Stroke Impact Scale [ Time Frame: from baseline to 3 weeks ]
    Quality of life and impact of stroke after the intervention. The SIS 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 Outcome Measures :
  1. Change in Hospital Anxiety and Depression Scale [ Time Frame: from baseline to 3 weeks ]
    Anxiety and depression with scores ranging from 0 (no depression/anxiety) to 21 (severe depressive/anxious symptoms)

  2. Change in NIH 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 ]
    Quality of life is assessed in 4 domains. Higher scores denote higher quality of life.

  5. Post-Study System Usability Questionnaire [ Time Frame: 3 weeks ]
    10-item scale assessing the usability of the online mindfulness program. Higher scores indicate lower usability.

  6. Change in Zarit Burden Interview [ Time Frame: from baseline to 3 weeks ]
    Caregiver burden. Scores range from 0-88 with higher scores indicating greater burden.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A convenience sample of 5-10 people with stroke and their caregivers will be recruited.
Criteria

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 smartphone
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553679


Contacts
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Contact: Marika Demers, PhD 3234421996 demers@pt.usc.edu

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Marika Demers, PhD    323-442-1996    demers@pt.usc.edu   
Principal Investigator: Carolee Winstein, PhD         
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Carolee Winstein, PhD University of Southern California
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Responsible Party: Carolee Winstein, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT04553679    
Other Study ID Numbers: UP-20-00568
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolee Winstein, University of Southern California:
Mindfulness
Rehabilitation
Caregiver
Attention to variability
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases