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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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

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Worry Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Teleconference Mindfulness Intervention Group

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

Group Type OTHER

Teleconference Mindfulness Intervention

Intervention Type 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.

Smartphone App Mindfulness Intervention Group

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

Group Type OTHER

Smartphone App Mindfulness Intervention

Intervention Type 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.

Waitlist Control Group

No intervention; control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes