Clinical trial NCT04553679: Mindfulness After Stroke
Official title: Development of an Online Mindfulness Program for Stroke Survivors and Their Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Caregiver Burden
Keywords: Mindfulness
Rehabilitation
Caregiver
Attention to variability
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of 5-10 people with stroke and their caregivers will be recruited.

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.

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.

Eligibility 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 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

Primary outcomes:
measure: Change in Stroke Impact Scale
timeFrame: from baseline to 3 weeks
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: from baseline to 3 weeks
measure: Change in National Institute of Health Perceived Stress Survey
timeFrame: from baseline to 3 weeks
measure: Change in Single-Item Sleep Quality Scale
timeFrame: from baseline to 3 weeks
measure: Change in World Health Organization Quality of Life-bref
timeFrame: from baseline to 3 weeks
measure: Adapted Post-Study System Usability Questionnaire
timeFrame: 3 weeks
measure: Change in Zarit Burden Interview
timeFrame: from baseline to 3 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Carolee Winstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: