AzTrials
AzTrials

BehaviorCRSRNCT04000841

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

A study testing Mindful You mobile app in people with Behavior, run by IRIS Media Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Behavior
What is being tested?
Mindful You mobile app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteUnited States
Study dates
1 Feb 2021to 22 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • n/a

Trial locations and contacts

1 site in 1 country.

United States1 site
  • IRIS Educational Media

    Eugene, Oregon, 97401

Other trials in United States

About this study

Official title: Culturally Responsive Stress Reduction: A Mobile Mindfulness Application to Support Health Promotion for African Americans

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.

Read the 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
Being tested
Mindful You mobile app
Keywords
stress, emotion regulation
Medical subject headings
Behavior, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful You mobile appBehavioural

    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.
Study groups in NCT04000841
Study groupRoleWhat they receive
InterventionExperimentalIntervention 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.
Receives: Behavioral: Mindful You mobile app
Waitlist ControlNo interventionWaitlist control participants will continue business as usual with regards to stress-management and reduction.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline and 12 weeks

Secondary outcomes (6)
  1. Change in Emotion Regulation

    Emotion regulation will be assessed by the Difficulty in Emotion Regulation Scale Short Form (DERS-SF), a 18 item frequency scale ranging from 1 (almost never; 0-10%) to 5 (almost always; 91-100%) with higher scores indicating less emotional regulation (negative change scores indicate better outcomes). Single score and 6 subscales (strategies, non-acceptance, impulse, goals, awareness, and clarity) can be analyzed as either total score or average scores. Total scores on the full scale range from 18 to 90. Subscales have three items each, thus total scores on the subscales range from 3 to 15.

    Measured: Baseline and 12 weeks

  2. Change in Mindfulness

    Mindfulness will be assessed by the Five Facet Mindfulness Questionnaire (FFMQ), a 24-item frequency scale with scores ranging from 1 (never) to 5 (very often). This scale provides subscales with four having five items each (describe, act with awareness, nonjudgmental, and non-reactance) and on having four items (observe). Total scores range from 5 to 25 on the five-item subscales and 4 to 20 on the four-item subscale, with higher scores indicating indicating more mindfulness. Thus positive changes at posttest indicate better outcomes.

    Measured: Baseline and 12 weeks

  3. Change in Attitudes toward Mindfulness

    Attitudes toward general use of mindfulness techniques as well as program specific recommendations, affective responses towards the items, and outcome expectancies will be measured using the Attitudes Towards Mindfulness Scale (MTMS), a 10-item scale developed in Phase I. The MTMS is a 10-item Likert-like scale, on a 5 point scale ranging from 1 "strongly disagree" to 5 "strongly agree" which measured positive attitudes towards mindfulness strategies (higher change scores indicate a better outcome). Example items included "Practicing mindfulness can help me reduce my stress" and "Knowing what I am thinking in the moment is important". The MTMS demonstrated strong internal reliability during Phase I (alpha = .91 at pretest and .94 at posttest). The average score of the scale is used in analysis.

    Measured: Baseline and 12 weeks

  4. Change in Perceived Behavioral Control

    Perceived Behavioral Control (self-efficacy) will be measured using the Mindfulness Self-Efficacy Scale (MSES) a 12-item Likert-like scale developed in Phase I based on the content about ability and competence in stress reduction through mindfulness. The MSES evaluated self-efficacy, by asking how confident on a 5 point scale ranging from 1 "not at all confident" to 5 "very confident" participants were in their ability to use the skills taught in the course, for example "Take time to breathe" and "Pay attention to tasks in the moment". Higher scores indicated greater self-efficacy (better outcome). The MSES demonstrated strong internal reliability in Phase I (alpha = .90 at pretest and .91 at posttest). The average score of the scale is used in analysis.

    Measured: Baseline and 12 weeks

  5. Change in Mindfulness Behaviors

    Mindfulness Behaviors i.e., actual behavioral change, will be assessed through the Mindfulness Behavior Usage Scale (MBUS) a self-report of 12 mindfulness activities as well as usage data provided through the app. The MBUS is a 12-item frequency scale, asking how often in the last week participants engaged in mindfulness strategies, ranging from 1 "never' to 4 "daily" (higher change scores indicate better outcomes). For example, "How often did you take time to breathe" and "Pay attention to tasks in the moment". The MBUS demonstrated good internal reliability (alpha = .94 at pretest and .90 at posttest).

    Measured: Baseline and 12 weeks

  6. Change in Knowledge of Mindfulness

    Knowledge about mindfulness techniques will be assessed pre- and post- to determine the extent to which participants understand basic knowledge delivered during the intervention. Knowledge items will be derived from the conceptual and practical content. In Phase I we used a 10-item multiple-choice assessment of participants' knowledge about mindfulness. For Phase II additional items will be added to reflect the new information presented in the program.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2019
  2. Study start1 Feb 2021
  3. Primary completion22 Feb 2022
  4. Study completion22 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04000841
Sponsor's protocol ID
2R44MD012284-02
Acronym
CRSR
Status last verified
Jun 2022
First submitted
20 Jun 2019
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindful You mobile app in people with Behavior, run by IRIS Media Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Perceived Stress (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in