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临床试验/NCT05027113
NCT05027113已完成不适用

App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: A Randomized Control Trial

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2021年10月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
1
主要终点
Change in stress

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participants will be aware of whether they were randomized to the intervention group or the wait-list control group. The intervention is self-guided and automated through the use of a smartphone app. As such, masking is not an issue. The principal investigator will not be involved with randomization. Assessments are self-administered via online questionnaires. As such, masking is not relevant in terms of outcomes assessors.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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
  • •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.

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Mindfulness meditation (Behavioral)

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).

结局指标

主要结局

Change in stress

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Change in mindfulness(Through study completion, 1-2 months)
  • Change in self-Compassion(Through study completion, 1-2 months)
  • Change in experiential avoidance(Through study completion, 1-2 months)
  • Change in rumination(Through study completion, 1-2 months)
  • Change in emotion suppression(Through study completion, 1-2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Ramos, MA, CPhil

Principal Investigator

University of California, Los Angeles

研究点 (1)

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