Clinical trial NCT04000841: Culturally Responsive Stress Reduction: A Mobile Mindfulness Application for African Americans (CRSR)
Official title: Culturally Responsive Stress Reduction: A Mobile Mindfulness Application to Support Health Promotion for African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: stress
emotion regulation
Lead sponsor: IRIS Media Inc
Sponsor class: OTHER
Collaborators: name: Spelman College
First posted: 2019-06-27
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Perceived Stress
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Emotion Regulation
timeFrame: Baseline and 12 weeks
measure: Change in Mindfulness
timeFrame: Baseline and 12 weeks
measure: Change in Attitudes toward Mindfulness
timeFrame: Baseline and 12 weeks
measure: Change in Perceived Behavioral Control
timeFrame: Baseline and 12 weeks
measure: Change in Mindfulness Behaviors
timeFrame: Baseline and 12 weeks
measure: Change in Knowledge of Mindfulness
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Eugene
country: United States
facility: IRIS Educational Media
state: Oregon
Study officials:
References: