NCT05180513

Mellowing Mind: Comparing Two Technology Based Mindfulness Interventions for Stress Impacted by COVID-19 in Underserved Communities

Comparing Two Ways to Mitigate the Impact of the COVID-19 Pandemic on Mental Health Among Adults From Underserved and Racial Minority Communities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this randomized controlled 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. Participants will be randomly assigned to a teleconference MBSR program, a MBSR smartphone app program, or a waitlist control group. Each intervention includes participation in a 9-week (8 sessions plus an introduction) mindfulness intervention that consists of instruction and daily practice. Questionnaires and semi-structured interviews will be administered at mid-intervention, post-intervention, and one-month and three-month follow-up points. It is hypothesized that participants in the two intervention groups will show measurable and sustained improvement in the primary outcome, worry, as well as in the secondary outcomes, anxiety and related mental health effects. It is further hypothesized that the smartphone app mindfulness intervention will show similar effectiveness to the teleconference mindfulness intervention.

Conditions

• Worry
• Stress

Interventions

Type	Name	Description
BEHAVIORAL	Teleconference Mindfulness Intervention	The teleconference intervention is administered by a trained interventionist via Zoom and is based on a manual adapted from a traditional MBSR version. Practices and activities include meditations, mindful breathing exercises and movements, discussions, and reflections, which participants learn at weekly sessions and practice on their own throughout the week. To adapt the traditional MBSR program for the target community population, intervention materials were reviewed for feedback from community stakeholders, and modified according to their feedback.
BEHAVIORAL	Smartphone App Mindfulness Intervention	The smartphone app intervention is administered through the app. The smartphone app aligns with the traditional MBSR format, but training and practice is done individually and independently by members of this group. To adapt the traditional MBSR program for the target community population, the app was tested by community stakeholders and modified according to their feedback.

Timeline

• Start date: 2021-05-14
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-01-06
• Last updated: 2024-09-20

Locations

1 site across 1 country: United States