Mellowing Mind: Comparing Two Technology Based Mindfulness Interventions for Stress Impacted by C… (NCT05180513) | Clinical Trial Compass
CompletedNot Applicable
Mellowing Mind: Comparing Two Technology Based Mindfulness Interventions for Stress Impacted by COVID-19 in Underserved Communities
United States270 participantsStarted 2021-05-14
Plain-language summary
The purpose of this study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years and older
* Significant worry as per the Penn State Worry Questionnaire-Abbreviated \[PSWQ-A\]
* Fluent in English
* Reside in one of the local city zip codes, identified as underserved, and primarily African American, communities
Exclusion Criteria:
* Severe depression as per Patient Health Questionnaire \[PHQ-9\]
* Active suicidal intent as per PHQ-9 question 9
* Diagnosis of psychosis, or bipolar disorder, or moderate or severe substance use disorder in the past month as per self report
* Cognitive impairment as per (modified) Short Portable Mental Status Questionnaire \[SPMSQ\]
* Currently receiving psychotherapy or behavioral counseling, including MBSR
* Change in psychotropic medications within the last month as per self report
* Unable to communicate in a way that would allow for participation in screenings or sessions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Worry from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Timeframe: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention