Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05027113
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2021-08-13
Brief Title:
App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress A Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the United States people of color POC are disproportionally affected by stressors related to raceethnicity 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 ie 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 ie 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
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 ie 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 ie 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 raceethnicity 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 ie perceived differential and unfair treatment among individuals vicarious discrimination ie observing members of ones raceethnicity being victimized institutional practices ie laws and policies that limit access to services and opportunities and cultural traditions ie beliefs and practices that reinforce the idea of NLWs superiority over POC
When differential or unfair treatment is perceived it triggers physiological eg cardiovascular reactivity dysregulated HPA axis activity cognitive-affective eg rumination emotion suppression and behavioral eg 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 individuals 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 ones experience ie 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 ones 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 ones 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 eg unwillingness to experience sadness after being discriminated against and behavioral avoidance eg 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 ie the passive and repetitive focus on the causes and consequences of ones distress and emotion suppression ie 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 eg 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 ie stress anxiety depression occur via hypothesized mechanisms of change ie 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 ie extent to which the intervention is agreeable or satisfactory adherence ie actual use of the intervention and satisfaction ie positive attitude toward the intervention received in this high-risk POC population Considering researchers and clinicians concerns regarding potential cultural mismatches between POCs 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
When differential or unfair treatment is perceived it triggers physiological eg cardiovascular reactivity dysregulated HPA axis activity cognitive-affective eg rumination emotion suppression and behavioral eg 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 individuals 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 ones experience ie 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 ones 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 ones 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 eg unwillingness to experience sadness after being discriminated against and behavioral avoidance eg 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 ie the passive and repetitive focus on the causes and consequences of ones distress and emotion suppression ie 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 eg 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 ie stress anxiety depression occur via hypothesized mechanisms of change ie 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 ie extent to which the intervention is agreeable or satisfactory adherence ie actual use of the intervention and satisfaction ie positive attitude toward the intervention received in this high-risk POC population Considering researchers and clinicians concerns regarding potential cultural mismatches between POCs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None