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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.

Completed

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

Official record
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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
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

Other trials in United States

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.

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 groups in NCT05027113
Study groupRoleWhat they receive
Mind-UsExperimentalUse 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 FirstNo interventionWait-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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted30 Aug 2021
  2. Study start13 Oct 2021
  3. Primary completion2 Dec 2022
  4. Study completion2 Dec 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
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)
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 25373390
  • Aguilera 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 28483742
  • Aguilera 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 25525292
  • Alkhaldi 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 26747176
  • Alsubaie 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 28501707
  • Baumel 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 31573916
  • Benish 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 21604860
  • Beshai 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 32942203
  • Biggers 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 33584869
  • Bor 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 29937193
  • Borghouts 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 33759801
  • Brake 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 26956654
  • Brondolo 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 19127420
  • Brown 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

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.

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