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

University at Buffalo (UB)

Status: Completed

Conditions: Worry; Stress

Treatments: Behavioral: Teleconference Mindfulness Intervention; Behavioral: Smartphone App Mindfulness Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05180513

COVID-2020C2-1115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

270 participants in 3 patient groups

Teleconference Mindfulness Intervention Group

Other group

Description:

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

Treatment:

Behavioral: Teleconference Mindfulness Intervention

Smartphone App Mindfulness Intervention Group

Other group

Description:

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

Treatment:

Behavioral: Smartphone App Mindfulness Intervention

Waitlist Control Group

No Intervention group

Description:

No intervention; control group