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

NCT05180513 | Completed

• 1 other identifier: COVID-2020C2-1115
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Worry; Stress

Keywords

Mindfulness Based Stress Reduction; Community Based Research

Outcome Measures

Primary Outcomes (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

  A total score on the Penn State Worry Questionnaire \[PSWQ\], a scaled measure with total scores ranging from 16 to 80, in which higher scores indicate greater severity of worry

  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

Secondary Outcomes (9)

• Changes in Anxiety 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

  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

• Changes in Perceived Stress 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

  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

• Changes in Depression 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

  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

• Changes in Sleep Quality 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

  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

• Changes in Loneliness 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

  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

Study Arms (3)

Teleconference Mindfulness Intervention Group

OTHER

MBSR training program that has been adapted for use via Zoom teleconferencing and for cultural relevancy

Behavioral: Teleconference Mindfulness Intervention

Smartphone App Mindfulness Intervention Group

OTHER

MBSR training program that has been adapted for use via smartphone app and for cultural relevancy

Behavioral: Smartphone App Mindfulness Intervention

Waitlist Control Group

NO INTERVENTION

No intervention; control group

Interventions

Teleconference Mindfulness Intervention BEHAVIORAL

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.

Teleconference Mindfulness Intervention Group

Smartphone App Mindfulness Intervention BEHAVIORAL

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.

Smartphone App Mindfulness Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

State University of New York, University at Buffalo

Buffalo, New York, 14214, United States

Location

Study Officials

• Yu-Ping Chang, PhD

  SUNY at Buffalo School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor and Associate Dean for Research and Scholarship

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: January 6, 2022
• Study Start: May 14, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

US (1)