Stress, PsychologicalNCT05027113
App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress
A study testing Mindfulness meditation in people with Stress, Psychological and Anxiety, run by University of California, Los Angeles at 1 site in United States.
Trial summary
In the United States, people of color (POC) are disproportionally affected by stressors related to race/ethnicity compared with their non-Latinx White (NLW). Considering POC exposed to race-related stress are at high risk of developing a mental health disorder, there is a clear need for treatments that allow… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Psychological, Anxiety, Depression
- What is being tested?
- Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to 2 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals interested in participating in this study will complete an online screening questionnaire using Qualtrics, a platform that is smartphone compatible. For study inclusion, participants are required to:
- Identify as a member of a people of color (POC) group
- Report experiencing elevated levels of race-related stress (i.e., a score of 55 in the IRRS-B or a score of 12 in the MDM)
- Speak and read English,
- Not receive psychological services currently
- Not have practiced mindfulness meditation for more than two hours in the month prior to study commencement
Show all 12Show fewer
- Own a smartphone with access to the internet
- Be willing to install the MBI app and accept daily notifications and text reminders
- Be at least 18 years old
- Screening Measures:
- Race-Related Stress. The 22-item Index of Race-Related Stress-Brief (IRRS-B) measures multiple sources of race-related stress, including Individual, Institutional, and Cultural. Participants rate items on a scale ranging from 0 (This Never Happened to Me) to 4 (This Event Happened and I was Extremely Upset), with higher scores indicating more race-related stress. The IRRS-B was developed with a POC sample (i.e., Blacks), showing adequate reliability (α = .78) for both Cultural and Individual subscales and acceptable reliability (α = .69) for the Institutional subscale. For study inclusion, participants need to obtain a score of 55, which represents elevated race-related stress.
- Perceived Discrimination. The 8-item Multicultural Discrimination Module (MDM) measures perceived discrimination. Participants rate items on a scale ranging from 1 (Never) to 4 (Often) with higher scores indicating more levels of perceived discrimination. The MDM was developed using a U.S. population-based sample (approximately 40% POC) and has shown good internal consistency (α = .81 - .88) in a previous study. For study inclusion, participants need to obtain a score of 12, which represents the 75th percentile of the population distribution.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: A Randomized Control Trial
In the United States, people of color (POC) are disproportionally affected by stressors related to race/ethnicity compared with their non-Latinx White (NLW). Considering POC exposed to race-related stress are at high risk of developing a mental health disorder, there is a clear need for treatments that allow individuals to cope effectively with these stressors.
Among many evidence-based treatments available, mindfulness-based interventions (MBIs) may be particularly well suited to help POC cope. MBIs are hypothesized to be effective via increases in mindfulness and self-compassion, as well as reductions in experiential avoidance, rumination, and emotion suppression. Despite their effectiveness, MBIs rarely reach POC. As such, innovative strategies such as self-directed app-based intervention may reduce the treatment gap.
Considering the lack of research examining the effectiveness of MBIs among POC, especially those who experience elevated levels of race-related stress, this study will employ a randomized control trial (RCT) approach to examine whether receiving an app-based MBI engages the hypothesized mechanisms of change (i.e., mindfulness, self-compassion, experiential avoidance, rumination, emotion suppression) among POC. Similarly, the study will test whether the intervention leads to decreases in the negative mental health outcomes more often associated with exposure to race-related stress (i.e., stress, anxiety, depression). Acceptability, adherence, and satisfaction also will be analyzed to explore whether a non-culturally adapted MBI is still relevant for POC who face race-related stress. Results from this trial will contribute to the nascent data on MBI acceptability and effectiveness with POC. To the investigators' knowledge, this study will also be the first to include a sample of POC recruited based on elevated levels of race-related stress, a high-risk population that is not commonly targeted in MBI research.
Read the detailed description
In the United States, people of color (POC) are disproportionally affected by stressors related to race/ethnicity compared with their non-Latinx White (NLW) counterparts, with approximately 70% of POC reporting having experienced some form of discrimination in their lives and 60% reporting facing day-to-day discriminatory treatment. Race-related stress is the psychological distress associated with appraising a situation as disturbing or burdensome because of negative racial bias. Race-related stressors have multiple forms, such as direct interpersonal discrimination (i.e., perceived differential and unfair treatment among individuals), vicarious discrimination (i.e., observing members of one's race/ethnicity being victimized), institutional practices (i.e., laws and policies that limit access to services and opportunities), and cultural traditions (i.e., beliefs and practices that reinforce the idea of NLW's superiority over POC).
When differential or unfair treatment is perceived, it triggers physiological (e.g., cardiovascular reactivity, dysregulated HPA axis activity), cognitive-affective (e.g., rumination, emotion suppression), and behavioral (e.g., avoidance, aggression) responses that prepare the individual to confront the situation. Although this acute stress response may be beneficial in the short term, the chronic and unpredictable nature of race-related stressors often depletes an individual's psychological resources and increases their vulnerability to developing mental health disorders. Metanalytic work supports this stress-response model among POC, showing that exposure to race-related stress is a consistent predictor of increases in mental health problems, including overall stress, anxiety, and depressive symptoms.
Among many EBTs available, mindfulness-based interventions (MBIs) may be particularly well suited to achieve these goals. Mindfulness is a psychological trait associated with staying in the present moment with one's experience (i.e., physical sensations, thoughts, emotions, behaviors), endorsing a nonjudgmental and curious attitude, and cultivating acceptance and self-compassion. Self-compassion refers to an attitude of openness to one's own suffering without avoiding it, cultivating the desire to alleviate it without self-judgment. In MBIs, participants cultivate these two qualities through meditations -exercises aimed to gain awareness of one's experience with an accepting and compassionate attitude. Metanalyses show participants in MBIs exhibit increases in both mindfulness and self-compassion traits. Multiple metanalyses have also shown that increases in mindfulness and self-compassion are two of the mechanisms by which MBIs lead to decreases in overall stress, anxiety, and depression.
Furthermore, mindfulness meditation could be particularly effective to help POC cope with race-related stress by reducing experiential avoidance. Experiential avoidance is the inability to remain in contact with distressing physical sensations, thoughts, and emotions, even when doing so causes harm in the long term. POC exposed to race-related stressors often develop emotional (e.g., unwillingness to experience sadness after being discriminated against) and behavioral avoidance (e.g., avoiding places where discrimination is likely to occur) that maintain mental health symptoms. As such, mindfulness meditation with its emphasis on bringing awareness to all experiences regardless of their negative valance may serve as an "exposure" strategy that reduces avoidance, leading to decreases in psychological distress.
Considering that rumination (i.e., the passive and repetitive focus on the causes and consequences of one's distress) and emotion suppression (i.e., the active reduction of emotionally expressive behavior when emotionally aroused) are maladaptive emotion regulation strategies often used by POC exposed to race-related stressors, researchers and clinicians have hypothesized that MBIs may be particularly well suited for this population. Research suggests that by cultivating acceptance of and nonjudgmental engagement with thoughts, mindfulness meditation disrupts ruminative tendencies. This hypothesis is consistent with multiple metanalyses showing that the reduction in rumination is a mediator leading to decreases in mental health problems, including stress, anxiety, and depression in MBI programs. In the case of emotion suppression, mindfulness meditation may help individuals identify, describe, and healthy engage with emotions triggered by race-related stressors rather than suppress them, leading to decreases in mental health symptoms. At least one MBI trial has shown that emotion suppression is a significant mediator behind decreases in anxiety and depression among POC. Targeting emotion suppression may be particularly relevant, considering cultural norms and practices among some POC groups (e.g., Asian, Latinx) that encourage down-regulating emotion expression to promote group harmony.
Despite the significant mental health need among individuals who experience discrimination and the existence of promising interventions such as MBIs, POC face numerous barriers to care, including limited access to providers, financial and transportation constraints, as well as stigma. As such, it is not surprising that POC are less likely to seek or receive mental health services compared with their NLW counterparts. Although no single approach will eliminate all barriers driving mental health disparities, the use of technology to provide care could reduce this treatment gap.
Digital interventions have the potential to address the shortage of mental health professionals, mitigate logistic barriers to service utilization, decrease costs associated with EBT implementation, and engage individuals in care who may not seek services otherwise. Among many technological resources available, smartphones represent a promising vehicle for the provision of mental health services. The feasibility of this approach is supported by extensive ownership of mobile devices in the United States. For instance, approximately 81% of Americans have a smartphone, with POC having similar ownership rates as NLW. Compared with NLW, POC are also more likely to be "smartphone dependent" -meaning they rely on these devices to access the internet in the absence of broadband connection at home. Furthermore, POC are also more likely to use their smartphones to seek information about their health than their NLW counterparts. As such, app-based interventions using smartphones may be well-positioned to reach those affected by the digital divide observed in low-income households as these interventions capitalize on already available technology owned by POC.
In addition to their feasibility, there is a growing body of evidence supporting the efficacy of app-based mental health interventions. Although somewhat limited, existing data with POC samples are promising. In the case of app-based MBI, multiple metanalyses show that these interventions are effective in reducing overall stress, anxiety, and depression as well as increasing mindfulness and self-compassion. To the investigators' knowledge, experiential avoidance, rumination, and emotion suppression have not been examined as potential clinical targets in app-based MBIs.
Research Questions and Hypotheses
Aim 1 The purpose of this study is to examine whether this MBI engages relevant mechanisms of change for POC exposed to race-related stress. Based on previous metanalytic studies on mindfulness and self-compassion, the investigators hypothesize that POC who receive the intervention will experience significant increases in both variables compared with POC in the control group. Considering previous studies showing the crucial role of experiential avoidance and emotion suppression, the investigators hypothesize that POC who receive the intervention will experience significant decreases in these three variables compared with POC in the control group.
Aim 2 An additional goal of this study is to test whether POC who receive this MBI experience reductions in mental health symptoms often associated with experiencing race-related stress. Based on previous metanalytic studies, the investigators hypothesize that POC who receive the intervention will experience significant decreases in overall stress, anxiety, and depression compared with POC in the control group.
Aim 3 Related to previous aims, this study will examine whether decreases in the main outcomes of interest (i.e., stress, anxiety, depression) occur via hypothesized mechanisms of change (i.e., mindfulness, self-compassion, experiential avoidance, rumination, emotion suppression). Based on previous metanalytic studies, the investigators hypothesize that the five mechanisms of change examined will be significant mediators leading to decreases in the main outcomes of interest.
Aim 4 This study will also examine app-based MBI acceptability (i.e., extent to which the intervention is agreeable or satisfactory), adherence (i.e., actual use of the intervention), and satisfaction (i.e., positive attitude toward the intervention received) in this high-risk POC population. Considering researchers' and clinicians' concerns regarding potential cultural mismatches between POC's backgrounds and MBIs, the investigators will use both quantitative and qualitative data sources to examine treatment acceptability descriptively. Based on previous studies showing poor treatment engagement in self-directed app-based interventions, the investigators will describe treatment adherence with both behavioral markers and qualitative data. Finally, treatment satisfaction will also be measured using quantitative and qualitative methods. Given that these analyses are descriptive, the investigators do not have specific hypotheses.
- Conditions
- Stress, Psychological, Anxiety, Depression, Rumination, Emotional Regulation, Mindfulness
- Being tested
- Mindfulness meditation
- Keywords
- Race-Related Stress, Mental Health, Mindfulness, Meditation, App
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Depression, Rumination Syndrome, Emotional Regulation, Psychological Well-Being, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
Also called Mind-Us
Participants use the meditation app 10% Happier to practice mindfulness meditation (see detailed description in arm/group section)
| Study group | Role | What they receive |
|---|---|---|
| Mind-Us | Experimental | Use of the 10% Happier app to complete at least one meditation daily -with the possibility of exceeding this goal by choosing additional meditations- for 4 weeks. Participants will be asked to complete "The Basics" and "The Basics II" courses to familiarize themselves with the principles of mindfulness meditation. Each audio-recorded session begins with a short video providing psychoeducation around mindfulness meditation and teaching specific techniques (e.g., using the breath as an anchor, redirecting attention, noting thoughts and emotions). For the last two weeks of the program, participants will be invited to complete the "Essential Advice" course. This additional course is composed of 14 sessions ranging in length from 15 to 18 minutes. Receives: Behavioral: Mindfulness meditation |
| Assessments First | No intervention | Wait-list control group. Individuals in this group will complete baseline, mid-, and post-treatment assessments before receiving the intervention (i.e., 4 weeks after randomization). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress
The 10-item Perceived Stress Scale (PSS) measures stress. Participants rate items on a scale ranging from 0 (Never) to 4 (Very Often) with higher scores indicating more stress. The PSS has shown good reliability (α = .84 - .86) and validity, and it is commonly used in MBI research.
Measured: Through study completion, 1-2 months
Change in anxiety
The General Anxiety Disorder (GAD-7) measures anxiety symptoms. Participants rate items on a scale ranging from 0 (Not at all) to 3 (Nearly Every Day) with higher scores indicating more severe anxiety symptoms. The GAD-7 has shown good internal consistency (α = .89 - .90) and validity in POC samples.
Measured: Through study completion, 1-2 months
Change in depression
The 8-item Patient Health Questionnaire (PHQ-8) measures depressive symptoms. Participants rate items on a scale ranging from 0 (Not at all) to 3 (Nearly Every Day) with higher scores indicating more severe depressive symptoms.The PHQ-8 omits an item assessing suicidal ideation and self-harm included in the original PHQ-9, which makes it more adequate for self-guided digital intervention research. Furthermore, metanalytic work suggests that the PHQ-8 is practically equivalent to the original measure. The PHQ-8 has good reliability (α = .86 - .89) and has shown validity across different racial/ethnic groups.
Measured: Through study completion, 1-2 months
Secondary outcomes (5)
Change in mindfulness
The 15-item Mindful Attention Awareness Scale (MAAS) measures mindfulness trait. Participants rate items using a scale ranging from 1 (Almost Always 1) to 6 (Almost Never) with higher scores indicating more mindfulness. The MAAS has shown good internal consistency (α = .80 - .87) during its development.
Measured: Through study completion, 1-2 months
Change in self-Compassion
The 12-item Self-Compassion Scale, Short Form (SCS-SF) measures self-compassion trait. Participants rate items using a scale ranging from 1 (Almost Never) to 5 (Almost Always) with higher scores indicating more self-compassion. The SCS-SF has shown good internal consistency (α = .86) and validity in a sample with significant POC representation.
Measured: Through study completion, 1-2 months
Change in experiential avoidance
The 15-item Brief Experiential Avoidance Questionnaire (BEAQ) measures experiential avoidance. Participants rate their responses in a scale ranging from 1 (Strongly Disagree) to 6 (Strongly Agree) with higher scores indicating higher experiential avoidance. The BAEQ has shown good internal consistency (α = .80 - .86) and construct validity.
Measured: Through study completion, 1-2 months
Change in rumination
The 5-item Brooding subscale of the short version of the Ruminative Response Scale (RRS-SF) measures rumination. Participants rate their responses in a scale ranging from 1 (Almost Never) to 4 (Almost Always) with higher scores indicating more rumination. The RRS-SF Brooding subscale has shown adequate internal consistency (α = .79) and validity in studies with POC samples that experience discrimination.
Measured: Through study completion, 1-2 months
Change in emotion suppression
The 4-item Expressive Suppression of the Emotion Regulation Questionnaire (ERQ) measures emotion suppression. Participants rate their responses on a scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree) with higher scores indicating more emotion suppression. The Expressive Suppression subscale of the ERQ has shown an adequate reliability (α = .68 - .76) and validity in samples with significant POC representation.
Measured: Through study completion, 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start13 Oct 2021
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (112)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals who meet eligibility criteria will be randomized to either the intervention group (n = 40) or a wait-list control group (n = 40),
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Ramos, MA, CPhil, University of California, Los Angeles
- Investigators
- Giovanni Ramos, MA, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027113
- Sponsor's protocol ID
- 21-005750
- Status last verified
- May 2023
- First submitted
- 13 Aug 2021
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acabchuk, R. L., Simon, M. A., Low, S., Brisson, J. M., & Johnson, B. T. (2021). Measuring Meditation Progress with a Consumer-Grade EEG Device: Caution from a Randomized Controlled Trial. Mindfulness, 12(1), 68-81. https://doi.org/10.1007/s12671-020-01497-1
Aguilera A, Berridge C. Qualitative feedback from a text messaging intervention for depression: benefits, drawbacks, and cultural differences. JMIR Mhealth Uhealth. 2014 Nov 5;2(4):e46. doi: 10.2196/mhealth.3660.
PubMed 25373390Aguilera A, Bruehlman-Senecal E, Demasi O, Avila P. Automated Text Messaging as an Adjunct to Cognitive Behavioral Therapy for Depression: A Clinical Trial. J Med Internet Res. 2017 May 8;19(5):e148. doi: 10.2196/jmir.6914.
PubMed 28483742Aguilera A, Munoz RF. Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. Prof Psychol Res Pr. 2011 Dec 1;42(6):472-478. doi: 10.1037/a0025499.
PubMed 25525292Alkhaldi G, Hamilton FL, Lau R, Webster R, Michie S, Murray E. The Effectiveness of Prompts to Promote Engagement With Digital Interventions: A Systematic Review. J Med Internet Res. 2016 Jan 8;18(1):e6. doi: 10.2196/jmir.4790.
PubMed 26747176Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23.
PubMed 28501707Baumel A, Muench F, Edan S, Kane JM. Objective User Engagement With Mental Health Apps: Systematic Search and Panel-Based Usage Analysis. J Med Internet Res. 2019 Sep 25;21(9):e14567. doi: 10.2196/14567.
PubMed 31573916Benish SG, Quintana S, Wampold BE. Culturally adapted psychotherapy and the legitimacy of myth: a direct-comparison meta-analysis. J Couns Psychol. 2011 Jul;58(3):279-89. doi: 10.1037/a0023626.
PubMed 21604860Beshai S, Bueno C, Yu M, Feeney JR, Pitariu A. Examining the effectiveness of an online program to cultivate mindfulness and self-compassion skills (Mind-OP): Randomized controlled trial on Amazon's Mechanical Turk. Behav Res Ther. 2020 Nov;134:103724. doi: 10.1016/j.brat.2020.103724. Epub 2020 Sep 10.
PubMed 32942203Biggers A, Spears CA, Sanders K, Ong J, Sharp LK, Gerber BS. Promoting Mindfulness in African American Communities. Mindfulness (N Y). 2020 Oct;11(10):2274-2282. doi: 10.1007/s12671-020-01480-w. Epub 2020 Aug 21.
PubMed 33584869Bor J, Venkataramani AS, Williams DR, Tsai AC. Police killings and their spillover effects on the mental health of black Americans: a population-based, quasi-experimental study. Lancet. 2018 Jul 28;392(10144):302-310. doi: 10.1016/S0140-6736(18)31130-9. Epub 2018 Jun 21.
PubMed 29937193Borghouts J, Eikey E, Mark G, De Leon C, Schueller SM, Schneider M, Stadnick N, Zheng K, Mukamel D, Sorkin DH. Barriers to and Facilitators of User Engagement With Digital Mental Health Interventions: Systematic Review. J Med Internet Res. 2021 Mar 24;23(3):e24387. doi: 10.2196/24387.
PubMed 33759801Brake CA, Sauer-Zavala S, Boswell JF, Gallagher MW, Farchione TJ, Barlow DH. Mindfulness-Based Exposure Strategies as a Transdiagnostic Mechanism of Change: An Exploratory Alternating Treatment Design. Behav Ther. 2016 Mar;47(2):225-38. doi: 10.1016/j.beth.2015.10.008. Epub 2015 Nov 7.
PubMed 26956654Brondolo E, Brady Ver Halen N, Pencille M, Beatty D, Contrada RJ. Coping with racism: a selective review of the literature and a theoretical and methodological critique. J Behav Med. 2009 Feb;32(1):64-88. doi: 10.1007/s10865-008-9193-0. Epub 2009 Jan 6.
PubMed 19127420Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05027113
- Acronym / sponsor ID
- 21-005750
- Conditions
- Stress, Psychological, Anxiety, Depression, Rumination, Emotional Regulation, Mindfulness
- Keywords
- Race-Related Stress, Mental Health, Mindfulness, Meditation, App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 30 Aug 2021 (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.
In the United States, people of color (POC) are disproportionally affected by stressors related to race/ethnicity compared with their non-Latinx White (NLW). Considering POC exposed to race-related stress are at high risk of developing a mental health disorder, there is a clear need for treatments that allow individuals to cope effectively with these stressors.
Among many evidence-based treatments available, mindfulness-based interventions (MBIs) may be particularly well suited to help POC cope. MBIs are hypothesized to be effective via increases in mindfulness and self-compassion, as well as reductions in experiential avoidance, rumination, and emotion suppression. Despite their effectiveness, MBIs rarely reach POC. As such, innovative strategies such as self-directed app-based intervention may reduce the treatment gap.
Considering the lack of research examining the effectiveness of MBIs among POC, especially those who experience elevated levels of race-related stress, this study will employ a randomized control trial (RCT) approach to examine whether receiving an app-based MBI engages the hypothesized mechanisms of change (i.e., mindfulness, self-compassion, experiential avoidance, rumination, emotion suppression) among POC. Similarly, the study will test whether the intervention leads to decreases in the negative mental health outcomes more often associated with exposure to race-related stress (i.e., stress, anxiety, depression). Acceptability, adherence, and satisfaction also will be analyzed to explore whether a non-culturally adapted MBI is still relevant for POC who face race-related stress. Results from this trial will contribute to the nascent data on MBI acceptability and effectiveness with POC. To the investigators' knowledge, this study will also be the first to include a sample of POC recruited based on elevated levels of race-related stress, a high-risk population that is not commonly targeted in MBI research.
Detailed description
In the United States, people of color (POC) are disproportionally affected by stressors related to race/ethnicity compared with their non-Latinx White (NLW) counterparts, with approximately 70% of POC reporting having experienced some form of discrimination in their lives and 60% reporting facing day-to-day discriminatory treatment. Race-related stress is the psychological distress associated with appraising a situation as disturbing or burdensome because of negative racial bias. Race-related stressors have multiple forms, such as direct interpersonal discrimination (i.e., perceived differential and unfair treatment among individuals), vicarious discrimination (i.e., observing members of one's race/ethnicity being victimized), institutional practices (i.e., laws and policies that limit access to services and opportunities), and cultural traditions (i.e., beliefs and practices that reinforce the idea of NLW's superiority over POC).
When differential or unfair treatment is perceived, it triggers physiological (e.g., cardiovascular reactivity, dysregulated HPA axis activity), cognitive-affective (e.g., rumination, emotion suppression), and behavioral (e.g., avoidance, aggression) responses that prepare the individual to confront the situation. Although this acute stress response may be beneficial in the short term, the chronic and unpredictable nature of race-related stressors often depletes an individual's psychological resources and increases their vulnerability to developing mental health disorders. Metanalytic work supports this stress-response model among POC, showing that exposure to race-related stress is a consistent predictor of increases in mental health problems, including overall stress, anxiety, and depressive symptoms.
Among many EBTs available, mindfulness-based interventions (MBIs) may be particularly well suited to achieve these goals. Mindfulness is a psychological trait associated with staying in the present moment with one's experience (i.e., physical sensations, thoughts, emotions, behaviors), endorsing a nonjudgmental and curious attitude, and cultivating acceptance and self-compassion. Self-compassion refers to an attitude of openness to one's own suffering without avoiding it, cultivating the desire to alleviate it without self-judgment. In MBIs, participants cultivate these two qualities through meditations -exercises aimed to gain awareness of one's experience with an accepting and compassionate attitude. Metanalyses show participants in MBIs exhibit increases in both mindfulness and self-compassion traits. Multiple metanalyses have also shown that increases in mindfulness and self-compassion are two of the mechanisms by which MBIs lead to decreases in overall stress, anxiety, and depression.
Furthermore, mindfulness meditation could be particularly effective to help POC cope with race-related stress by reducing experiential avoidance. Experiential avoidance is the inability to remain in contact with distressing physical sensations, thoughts, and emotions, even when doing so causes harm in the long term. POC exposed to race-related stressors often develop emotional (e.g., unwillingness to experience sadness after being discriminated against) and behavioral avoidance (e.g., avoiding places where discrimination is likely to occur) that maintain mental health symptoms. As such, mindfulness meditation with its emphasis on bringing awareness to all experiences regardless of their negative valance may serve as an "exposure" strategy that reduces avoidance, leading to decreases in psychological distress.
Considering that rumination (i.e., the passive and repetitive focus on the causes and consequences of one's distress) and emotion suppression (i.e., the active reduction of emotionally expressive behavior when emotionally aroused) are maladaptive emotion regulation strategies often used by POC exposed to race-related stressors, researchers and clinicians have hypothesized that MBIs may be particularly well suited for this population. Research suggests that by cultivating acceptance of and nonjudgmental engagement with thoughts, mindfulness meditation disrupts ruminative tendencies. This hypothesis is consistent with multiple metanalyses showing that the reduction in rumination is a mediator leading to decreases in mental health problems, including stress, anxiety, and depression in MBI programs. In the case of emotion suppression, mindfulness meditation may help individuals identify, describe, and healthy engage with emotions triggered by race-related stressors rather than suppress them, leading to decreases in mental health symptoms. At least one MBI trial has shown that emotion suppression is a significant mediator behind decreases in anxiety and depression among POC. Targeting emotion suppression may be particularly relevant, considering cultural norms and practices among some POC groups (e.g., Asian, Latinx) that encourage down-regulating emotion expression to promote group harmony.
Despite the significant mental health need among individuals who experience discrimination and the existence of promising interventions such as MBIs, POC face numerous barriers to care, including limited access to providers, financial and transportation constraints, as well as stigma. As such, it is not surprising that POC are less likely to seek or receive mental health services compared with their NLW counterparts. Although no single approach will eliminate all barriers driving mental health disparities, the use of technology to provide care could reduce this treatment gap.
Digital interventions have the potential to address the shortage of mental health professionals, mitigate logistic barriers to service utilization, decrease costs associated with EBT implementation, and engage individuals in care who may not seek services otherwise. Among many technological resources available, smartphones represent a promising vehicle for the provision of mental health services. The feasibility of this approach is supported by extensive ownership of mobile devices in the United States. For instance, approximately 81% of Americans have a smartphone, with POC having similar ownership rates as NLW. Compared with NLW, POC are also more likely to be "smartphone dependent" -meaning they rely on these devices to access the internet in the absence of broadband connection at home. Furthermore, POC are also more likely to use their smartphones to seek information about their health than their NLW counterparts. As such, app-based interventions using smartphones may be well-positioned to reach those affected by the digital divide observed in low-income households as these interventions capitalize on already available technology owned by POC.
In addition to their feasibility, there is a growing body of evidence supporting the efficacy of app-based mental health interventions. Although somewhat limited, existing data with POC samples are promising. In the case of app-based MBI, multiple metanalyses show that these interventions are effective in reducing overall stress, anxiety, and depression as well as increasing mindfulness and self-compassion. To the investigators' knowledge, experiential avoidance, rumination, and emotion suppression have not been examined as potential clinical targets in app-based MBIs.
Research Questions and Hypotheses
Aim 1 The purpose of this study is to examine whether this MBI engages relevant mechanisms of change for POC exposed to race-related stress. Based on previous metanalytic studies on mindfulness and self-compassion, the investigators hypothesize that POC who receive the intervention will experience significant increases in both variables compared with POC in the control group. Considering previous studies showing the crucial role of experiential avoidance and emotion suppression, the investigators hypothesize that POC who receive the intervention will experience significant decreases in these three variables compared with POC in the control group.
Aim 2 An additional goal of this study is to test whether POC who receive this MBI experience reductions in mental health symptoms often associated with experiencing race-related stress. Based on previous metanalytic studies, the investigators hypothesize that POC who receive the intervention will experience significant decreases in overall stress, anxiety, and depression compared with POC in the control group.
Aim 3 Related to previous aims, this study will examine whether decreases in the main outcomes of interest (i.e., stress, anxiety, depression) occur via hypothesized mechanisms of change (i.e., mindfulness, self-compassion, experiential avoidance, rumination, emotion suppression). Based on previous metanalytic studies, the investigators hypothesize that the five mechanisms of change examined will be significant mediators leading to decreases in the main outcomes of interest.
Aim 4 This study will also examine app-based MBI acceptability (i.e., extent to which the intervention is agreeable or satisfactory), adherence (i.e., actual use of the intervention), and satisfaction (i.e., positive attitude toward the intervention received) in this high-risk POC population. Considering researchers' and clinicians' concerns regarding potential cultural mismatches between POC's backgrounds and MBIs, the investigators will use both quantitative and qualitative data sources to examine treatment acceptability descriptively. Based on previous studies showing poor treatment engagement in self-directed app-based interventions, the investigators will describe treatment adherence with both behavioral markers and qualitative data. Finally, treatment satisfaction will also be measured using quantitative and qualitative methods. Given that these analyses are descriptive, the investigators do not have specific hypotheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals who meet eligibility criteria will be randomized to either the intervention group (n = 40) or a wait-list control group (n = 40),
| Arm | Type | Receives |
|---|---|---|
| Mind-Us | Experimental | Behavioral: Mindfulness meditationUse of the 10% Happier app to complete at least one meditation daily -with the possibility of exceeding this goal by choosing additional meditations- for 4 weeks. Participants will be asked to complete "The Basics" and "The Basics II" courses to familiarize themselves with the principles of mindfulness meditation. Each audio-recorded session begins with a short video providing psychoeducation around mindfulness meditation and teaching specific techniques (e.g., using the breath as an anchor, redirecting attention, noting thoughts and emotions). For the last two weeks of the program, participants will be invited to complete the "Essential Advice" course. This additional course is composed of 14 sessions ranging in length from 15 to 18 minutes. |
| Assessments First | No intervention | –Wait-list control group. Individuals in this group will complete baseline, mid-, and post-treatment assessments before receiving the intervention (i.e., 4 weeks after randomization). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Individuals interested in participating in this study will complete an online screening questionnaire using Qualtrics, a platform that is smartphone compatible. For study inclusion, participants are required to:
- Identify as a member of a people of color (POC) group
- Report experiencing elevated levels of race-related stress (i.e., a score of 55 in the IRRS-B or a score of 12 in the MDM)
- Speak and read English,
- Not receive psychological services currently
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Mindfulness meditationAlso: Mind-UsParticipants use the meditation app 10% Happier to practice mindfulness meditation (see detailed description in arm/group section) | Behavioural | Mind-Us |
Primary outcome
Change in stress
Time frame: Through study completion, 1-2 months
The 10-item Perceived Stress Scale (PSS) measures stress. Participants rate items on a scale ranging from 0 (Never) to 4 (Very Often) with higher scores indicating more stress. The PSS has shown good reliability (α = .84 - .86) and validity, and it is commonly used in MBI research.
Change in anxiety
Time frame: Through study completion, 1-2 months
The General Anxiety Disorder (GAD-7) measures anxiety symptoms. Participants rate items on a scale ranging from 0 (Not at all) to 3 (Nearly Every Day) with higher scores indicating more severe anxiety symptoms. The GAD-7 has shown good internal consistency (α = .89 - .90) and validity in POC samples.
Change in depression
Time frame: Through study completion, 1-2 months
The 8-item Patient Health Questionnaire (PHQ-8) measures depressive symptoms. Participants rate items on a scale ranging from 0 (Not at all) to 3 (Nearly Every Day) with higher scores indicating more severe depressive symptoms.The PHQ-8 omits an item assessing suicidal ideation and self-harm included in the original PHQ-9, which makes it more adequate for self-guided digital intervention research. Furthermore, metanalytic work suggests that the PHQ-8 is practically equivalent to the original measure. The PHQ-8 has good reliability (α = .86 - .89) and has shown validity across different racial/ethnic groups.
5 secondary outcomes
Change in mindfulness
Time frame: Through study completion, 1-2 months
Change in self-Compassion
Time frame: Through study completion, 1-2 months
Change in experiential avoidance
Time frame: Through study completion, 1-2 months
Change in rumination
Time frame: Through study completion, 1-2 months
Change in emotion suppression
Time frame: Through study completion, 1-2 months
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 25 May 2023.
- BackgroundAcabchuk, R. L., Simon, M. A., Low, S., Brisson, J. M., & Johnson, B. T. (2021). Measuring Meditation Progress with a Consumer-Grade EEG Device: Caution from a Randomized Controlled Trial. Mindfulness, 12(1), 68-81. https://doi.org/10.1007/s12671-020-01497-1
- Background: PubMed 25373390Aguilera A, Berridge C. Qualitative feedback from a text messaging intervention for depression: benefits, drawbacks, and cultural differences. JMIR Mhealth Uhealth. 2014 Nov 5;2(4):e46. doi: 10.2196/mhealth.3660.
- Background: PubMed 28483742Aguilera A, Bruehlman-Senecal E, Demasi O, Avila P. Automated Text Messaging as an Adjunct to Cognitive Behavioral Therapy for Depression: A Clinical Trial. J Med Internet Res. 2017 May 8;19(5):e148. doi: 10.2196/jmir.6914.
- Background: PubMed 25525292Aguilera A, Munoz RF. Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. Prof Psychol Res Pr. 2011 Dec 1;42(6):472-478. doi: 10.1037/a0025499.
- Background: PubMed 26747176Alkhaldi G, Hamilton FL, Lau R, Webster R, Michie S, Murray E. The Effectiveness of Prompts to Promote Engagement With Digital Interventions: A Systematic Review. J Med Internet Res. 2016 Jan 8;18(1):e6. doi: 10.2196/jmir.4790.
- Background: PubMed 28501707Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23.
- Background: PubMed 31573916Baumel A, Muench F, Edan S, Kane JM. Objective User Engagement With Mental Health Apps: Systematic Search and Panel-Based Usage Analysis. J Med Internet Res. 2019 Sep 25;21(9):e14567. doi: 10.2196/14567.
- Background: PubMed 21604860Benish SG, Quintana S, Wampold BE. Culturally adapted psychotherapy and the legitimacy of myth: a direct-comparison meta-analysis. J Couns Psychol. 2011 Jul;58(3):279-89. doi: 10.1037/a0023626.
- Background: PubMed 32942203Beshai S, Bueno C, Yu M, Feeney JR, Pitariu A. Examining the effectiveness of an online program to cultivate mindfulness and self-compassion skills (Mind-OP): Randomized controlled trial on Amazon's Mechanical Turk. Behav Res Ther. 2020 Nov;134:103724. doi: 10.1016/j.brat.2020.103724. Epub 2020 Sep 10.
- Background: PubMed 33584869Biggers A, Spears CA, Sanders K, Ong J, Sharp LK, Gerber BS. Promoting Mindfulness in African American Communities. Mindfulness (N Y). 2020 Oct;11(10):2274-2282. doi: 10.1007/s12671-020-01480-w. Epub 2020 Aug 21.
- Background: PubMed 29937193Bor J, Venkataramani AS, Williams DR, Tsai AC. Police killings and their spillover effects on the mental health of black Americans: a population-based, quasi-experimental study. Lancet. 2018 Jul 28;392(10144):302-310. doi: 10.1016/S0140-6736(18)31130-9. Epub 2018 Jun 21.
- Background: PubMed 33759801Borghouts J, Eikey E, Mark G, De Leon C, Schueller SM, Schneider M, Stadnick N, Zheng K, Mukamel D, Sorkin DH. Barriers to and Facilitators of User Engagement With Digital Mental Health Interventions: Systematic Review. J Med Internet Res. 2021 Mar 24;23(3):e24387. doi: 10.2196/24387.
- Individual participant dataSharing planned: No
Related trials for Stress, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
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.
Giovanni Ramos, MA principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation in people with Stress, Psychological and Anxiety, run by University of California, Los Angeles 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 12 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 25 May 2023. 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 stress (time frame: Through study completion, 1-2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05027113, which also lists 112 linked publications.
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 25 May 2023.