Clinical trial NCT05180513: Mellowing Mind: Comparing Two Technology Based Mindfulness Interventions for Stress Impacted by COVID-19 in Underserved Communities
Official title: Comparing Two Ways to Mitigate the Impact of the COVID-19 Pandemic on Mental Health Among Adults From Underserved and Racial Minority Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Worry
Stress
Keywords: Mindfulness Based Stress Reduction
Community Based Research
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-01-06
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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
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
measure: 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
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
measure: 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
timeFrame: 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
measure: 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
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
measure: 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
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
measure: Changes in Social Disconnectedness 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
measure: Changes in Mindfulness 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
measure: Quality of life, satisfaction with
timeFrame: 21 Weeks Change from Baseline score to score at mid-intervention, end of intervention, and follow-up scores at one month and three months past end of intervention
measure: Changes in Psychological Well-being 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
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University of New York, University at Buffalo
state: New York
Study officials:
affiliation: SUNY at Buffalo School of Nursing
name: Yu-Ping Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: