Culturally Responsive Stress Reduction: A Mobile Mindfulness Application for African Americans (CRSR)

NCT ID: NCT04000841

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-02-22

Brief Summary

Over a 12-week period the investigators will test whether, compared to the Waitlist-Control (WC) condition, administration of the full CRSR intervention improves participants self-reported outcomes of stress, self-efficacy, mindfulness, use of mindfulness strategies, and knowledge. The investigators also will examine the usability, cultural relevance, and user satisfaction.

Detailed Description

The proposed intervention, Culturally Responsible Stress Reduction: A Mobile Mindfulness Application to Support Health Promotion for African Americans (CRSR), is designed to encourage the use of mindfulness to mitigate the disproportionate amount of stress-related health disparities facing African Americans. Current mindfulness approaches have been unsuccessful in engaging this population. This proposal aims to bridge this disparity by developing an mHealth (mobile health) mindfulness application ("app") tailored specifically to the cultural values of the African American community.

Mindfulness involves meditative practices that cultivate purposeful and nonjudgmental attention to current thoughts, emotions, and physical sensations in the body. Mindfulness has been incorporated into widely-used interventions, including Acceptance and Commitment Therapy (ACT). The CRSR app will be grounded in ACT and will integrate the convenience of mobile technology with tailored content to allow users to shift from potentially harmful culturally prescribed stress-coping activities (e.g., self-reliance, emotional suppression) to adaptive mindfulness-based stress-coping activities aligned with culturally specific values. This integration of content, backed by theory and empirical evidence, effective instructional delivery, an interdisciplinary development team, and modern communication technology will produce an effective mHealth intervention.

The CRSR app features include guided meditations to connect the user to the present moment and a place of calm through culturally aligned exercises grounded in spirituality, orality, self-empowerment, and resilience; personalized notifications prompting users to reflect and engage with the app; periodic email messages on the importance mindfulness as a way increase control over physical and psychological health; and user-customized reminders.

Phase I included developing a testable prototype of the CRSR app, called Mindful You. The prototype provided functionality for participants to practice mindfulness and was used to test proof of concept, i.e., the feasibility and social acceptability of the CRSR app. Users experienced significantly decreased stress and increased self-efficacy. They also reported increased use of mindfulness behaviors and improved self-regulation. Phase II will iteratively build on the prototype to develop the final product and test its efficacy with a fully-powered randomized controlled trial.

Conditions

Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Intervention participants receive access to the Mindful You app for 12 weeks. They will use the app to listen to guided meditations and to receive notifications, messages, and reminders that they select and ones sent to all participants by the app.

Group Type: EXPERIMENTAL

Mindful You mobile app

Intervention Type: BEHAVIORAL

The CRSR intervention consists of a native mobile application for Android and iOS devices. The mobile app includes:

• Guided meditations of varying length designed to connect the user to the present moment and a place of calm through culturally aligned exercises grounded in spirituality, orality, self-empowerment, and resilience.
• User-customized notifications prompting users to reflect and engage with the app, such as providing African American proverbs and quotes and asking simple questions like "What are you grateful for today?"
• Scheduled messages on the importance mindfulness as a way increase control over physical and psychological health
• User-customized reminders to do specific meditations and display personally selected images or messages.

Waitlist Control

Waitlist control participants will continue business as usual with regards to stress-management and reduction.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindful You mobile app

The CRSR intervention consists of a native mobile application for Android and iOS devices. The mobile app includes:

• Guided meditations of varying length designed to connect the user to the present moment and a place of calm through culturally aligned exercises grounded in spirituality, orality, self-empowerment, and resilience.
• User-customized notifications prompting users to reflect and engage with the app, such as providing African American proverbs and quotes and asking simple questions like "What are you grateful for today?"
• Scheduled messages on the importance mindfulness as a way increase control over physical and psychological health
• User-customized reminders to do specific meditations and display personally selected images or messages.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Identifies as African-American
• Can read, write, and understand English
• Have a valid email address
• Owns an iOS or Android mobile device

Exclusion Criteria

• n/a

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spelman College

UNKNOWN

Sponsor Role: collaborator

IRIS Media Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRIS Educational Media

Eugene, Oregon, United States

Countries

United States

Other Identifiers

2R44MD012284-02

Identifier Type: NIH

Identifier Source: org_study_id

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