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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindful You mobile app |
| Waitlist Control | No intervention | Waitlist 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.
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)
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
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
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
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
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
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.
- First posted27 Jun 2019
- Study start1 Feb 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRIS Media Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Spelman College
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Responsive Stress Reduction: A Mobile Mindfulness Application to Support Health Promotion for African Americans
- ClinicalTrials.gov ID
- NCT04000841
- Acronym / sponsor ID
- CRSR / 2R44MD012284-02
- Conditions
- Behavior
- Keywords
- stress, emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- IRIS Media IncUniversity, hospital or other
- Collaborators
- Spelman College
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindful You mobile appIntervention 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. |
| Waitlist Control | No intervention | –Waitlist control participants will continue business as usual with regards to stress-management and reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Identifies as African-American
- Can read, write, and understand English
- Have a valid email address
- Owns an iOS or Android mobile device
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful You mobile appThe 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. | Behavioural | Intervention |
Primary outcome
Change in Perceived Stress
Time frame: Baseline and 12 weeks
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).
6 secondary outcomes
Change in Emotion Regulation
Time frame: Baseline and 12 weeks
Change in Mindfulness
Time frame: Baseline and 12 weeks
Change in Attitudes toward Mindfulness
Time frame: Baseline and 12 weeks
Change in Perceived Behavioral Control
Time frame: Baseline and 12 weeks
Change in Mindfulness Behaviors
Time frame: Baseline and 12 weeks
Change in Knowledge of Mindfulness
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.