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

NCT04000841 | Completed

• 1 other identifier: 2R44MD012284-02
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior

Keywords

stress; emotion regulation

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Stress

  Stress will be assessed using the Perceived Stress Scale (PSS), a 10-item frequency scale that evaluates the amount of stress in one's life.Scale ranges from 1 (never) to 4 (very often) with higher scores indicating more stress, therefore decreases at posttest would indicate better outcomes. The scores are averaged to get a total score on the scale which has good internal reliability (alpha = .90 in Phase I).

  Baseline and 12 weeks

Secondary Outcomes (6)

• Change in Emotion Regulation

  Baseline and 12 weeks

• Change in Mindfulness

  Baseline and 12 weeks

• Change in Attitudes toward Mindfulness

  Baseline and 12 weeks

• Change in Perceived Behavioral Control

  Baseline and 12 weeks

• Change in Mindfulness Behaviors

  Baseline and 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Mindful You mobile app

Waitlist Control

NO INTERVENTION

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

Interventions

Mindful You mobile app 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• n/a

Sponsors & Collaborators

• IRIS Media Inc: lead
• Spelman College: collaborator

Study Sites (1)

IRIS Educational Media

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Behavior; Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 27, 2019
• Study Start: February 1, 2021
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)