SMILE：评估正念作为 COVID-19 期间种族和民族人群干预措施的临床试验 (SMILE)

有源比较器：“MTIA”干预

正念训练教练管理 (“MTIA”) 干预将包含以下要素： 为期 8 周、每周 90 分钟的训练，经过修改的正念计划，该计划特别强调可行且与种族/族裔群体相关的训练，包括：a）关于压力、应对和复原力的教学法，b）对自我和他人的正念同情心； c) 正念沟通，包括非语言正念、正念倾听和正念说话。 MTIA 将由讲师指导、通过互联网提供（通过 Zoom）、交互式、基于小组的正念训练干预，将以小组形式对大约 9 人进行培训，并安排课外作业。

行为的：正念

正念冥想被描述为一种行为技巧，涉及对当下体验的注意力进行有意的自我调节，同时释放对过去或未来的想法（无论是简单的图像还是复杂的故事情节）的认知固着。 通过正念训练，个人学会唤起并维持一种不评判的当下意识状态。

有源比较器：“MAPP”干预

MindativityAPP（“MAPP”）是由 SMILE 研究团队开发的自我管理干预措施。 MAPP 供个人使用，有八个 MAPP 课程，由与 MTIA 课程相对应的正念练习和教学组成。 由于 MTIA 每周课程的时长为 90 分钟，因此 MAPP 作业建议每周花费大约 90 分钟来完成指定的课程，但形式灵活，方便参与者。 此外，每次课程都会包含基于正念的练习作业，通常每天 10 到 30 分钟不等。 建议完成的总天数为 49 天，相当于传统 8 周 MTIA 会议从开始到结束的时间；然而，这个个性化计划将具有灵活性。

行为的：正念

正念冥想被描述为一种行为技巧，涉及对当下体验的注意力进行有意的自我调节，同时释放对过去或未来的想法（无论是简单的图像还是复杂的故事情节）的认知固着。 通过正念训练，个人学会唤起并维持一种不评判的当下意识状态。

无干预：等候名单控制

等待名单控制 (WLC) 小组将参加所有研究评估会议，但在他们在研究中的角色完成之前不会获得正念干预。

Change From Baseline to Post-Intervention in the Generalized Anxiety Disorder-7 Scale

Generalized Anxiety Disorder scale (GAD-7) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior 2 weeks. Response categories range from 0 ("Not at all") to 3 ("Nearly every day"). Scores are summed leading to a range of 0-21. Higher scores indicate greater anxiety symptoms. The among-group differences in the change scores are compared by ANOVA.

Change From Baseline to Follow-up in the Generalized Anxiety Disorder-7 Scale

Generalized Anxiety Disorder scale (GAD-7) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior 2 weeks. Response categories range from 0 ("Not at all") to 3 ("Nearly every day"). Scores are summed leading to a range of 0-21. Higher scores indicate greater anxiety symptoms. The among-group differences in the change scores are compared by ANOVA.

简短健康调查 (SF-12) 的变更、随访基线

简短健康调查 (SF-12) 是一份包含 12 项的自我报告问卷，用于评估身体健康和心理健康的各个方面。 评分很复杂，包括正面和负面措辞的项目，并转化为 0-100 分。 分数越高表明身体和心理健康功能越好。

干预后 COVID-19 压力量表基线的变化

COVID-19 压力量表（缩写）是一份包含 18 项的自我报告问卷，旨在衡量过去 7 天内与 COVID 相关的焦虑程度。 测量三个高度相关的子量表：危险、污染和创伤性压力。 危险和污染分量表询问与病毒相关的担忧，反应类别范围从 0（“完全不”）到 4（“非常”）。 创伤应激子量表询问症状的频率，范围从 0（“从不”）到 4（“几乎总是”）。 对 0-72 范围内的子量表的响应进行汇总，值越高表明与新冠病毒相关的压力越大。 其中两个子量表，即与新冠病毒相关的强制检查和仇外心理，不再相关，因此不包含在内。

COVID-19 压力量表基线至随访的变化

COVID-19 压力量表（缩写）是一份包含 18 项的自我报告问卷，旨在衡量过去 7 天内与 COVID 相关的焦虑程度。 测量三个高度相关的子量表：危险、污染和创伤性压力。 危险和污染分量表询问与病毒相关的担忧，反应类别范围从 0（“完全不”）到 4（“非常”）。 创伤应激子量表询问症状的频率，范围从 0（“从不”）到 4（“几乎总是”）。 对 0-72 范围内的子量表的响应进行汇总，值越高表明与新冠肺炎相关的压力越大。 其中两个分量表，即与新冠病毒相关的强制检查和仇外心理，不再相关，因此不包含在内。

Change in Autonomic Activity From Baseline to Post-Intervention as Measured by Heart Period

Heart period (time in milliseconds between heartbeats) will be measured using the Polar H10 device. Range: 200-1500 msec

Change in Autonomic Activity From Baseline to Follow-up as Measured by Heart Period

Heart period (time in milliseconds between heartbeats) will be measured using the Polar H10 device. Range: 200-1500 msec

Change in Parasympathetic Activity Baseline to Post-Intervention as Measured by High-frequency Heart Rate Variability (HF-HRV)

High-frequency heart rate variability will be calculated from heart period data using CardioBatch Plus software. Range: 0 - 15 ln (msec)^2. Greater variability indicates greater parasympathetic activity.

Change in Parasympathetic Activity Baseline to Follow-up as Measured by High-frequency Heart Rate Variability (HF-HRV)

High-frequency heart rate variability will be calculated from heart period data using CardioBatch Plus software. Range: 0 - 15 ln(msec)^2. Greater variability indicates greater parasympathetic activity.

Change in Vagal Efficiency Baseline to Post-intervention Measured Using HF-HRV and Heart Period Coupling

Vagal Efficiency (VE) is calculated as the regression slope of heart period (HP, measured in milliseconds) on respiratory sinus arrhythmia (RSA, expressed as ln(ms²)) across short-time (15-second) epochs collected during seated, standing, and recovery periods of the sit-stand-sit task. VE is reported in units of ms / ln(ms²). The measure is computed only when each condition contains usable data and at least 6 valid epochs (≥50% of the condition).

Change in Vagal Efficiency Baseline to Follow-up Measured Using HF-HRV and Heart Period Coupling

Vagal Efficiency (VE) is calculated as the regression slope of heart period (HP, measured in milliseconds) on respiratory sinus arrhythmia (RSA, expressed as ln(ms²)) across short-time (15-second) epochs collected during seated, standing, and recovery periods of the sit-stand-sit task. VE is reported in units of ms / ln(ms²). The measure is computed only when each condition contains usable data and at least 6 valid epochs (≥50% of the condition).

Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Post-intervention.

The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self report questionnaire that measures mindfulness in a single construct. Respondents are asked to rate how much each of the statements applies to them on a 1-4 scale with 1=Rarely/Not at all and 4 = Almost always resulting in total scores of 12-48. Higher scores reflect greater mindfulness. The among-group differences in the change scores are compared by ANOVA.

Change in the Cognitive and Affective Mindfulness Scale - Revised Baseline to Follow-up

The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self report questionnaire that measures mindfulness in a single construct. Respondents are asked to rate how much each of the statements applies to them on a 1-4 scale with 1=Rarely/Not at all and 4 = Almost always resulting in total scores of 12-48. Higher scores reflect greater mindfulness. The among-group differences in the change scores are compared by ANOVA.

Change in the Perceived Stress Scale Baseline to Post-intervention.

The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire that measures the frequency of stress-related feelings in the past month. Responses vary from 0 ("Not at all" to 4 "Very often). Responses are summed resulting in a range of 0-40. Higher scores indicate higher perceived stress. The among-group differences in the change scores are compared by ANOVA.

Change in the Perceived Stress Scale Baseline to Follow-up.

The Perceived Stress Scale (PSS) is a 10-item self-report questionnaire that measures the frequency of stress-related feelings in the past month. Responses vary from 0 ("Not at all" to 4 "Very often). Responses are summed resulting in a range of 0-40. Higher scores indicate higher perceived stress. The among-group differences in the change scores are compared by ANOVA.

Change in the Post-traumatic Growth Inventory Baseline to Post-Intervention

The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of growth and self-improvement after a crisis. The measure consists of statements, such as "I changed my priorities about what is important in life." Responses vary from 0 ("I did not experience this change as a result of my crisis") to 5 ("I experienced this change to a very great degree as a result of my crisis," resulting in total scores of 0-105. Higher scores indicate more growth. The among-group differences in the change scores are compared by ANOVA.

Change in the Post-traumatic Growth Inventory Baseline to Follow-up

The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of growth and self-improvement after a crisis. The measure consists of statements, such as "I changed my priorities about what is important in life." Responses vary from 0 ("I did not experience this change as a result of my crisis") to 5 ("I experienced this change to a very great degree as a result of my crisis," resulting in total scores of 0-105. Higher scores indicate more growth. The among-group differences in the change scores are compared by ANOVA.

Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Post-intervention.

The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire that measures key symptoms of PTSD in response to a traumatic event. Respondents indicate the degree to which they are bothered by each symptom with categories ranging from 0 ("Not at All") to 4 ("Extremely") resulting in total scores of 0-80. Higher scores indicate presence of more symptomatology. The among-group differences in the change scores are compared by ANOVA.

Change in the Post-traumatic Stress Disorder Checklist for DSM-V, Baseline to Follow-up.

The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire that measures key symptoms of PTSD in response to a traumatic event. Respondents indicate the degree to which they are bothered by each symptom with categories ranging from 0 ("Not at All") to 4 ("Extremely") resulting in total scores of 0-80. Higher scores indicate presence of more symptomatology. The among-group differences in the change scores are compared by ANOVA.

Change in the Center for Epidemiologic Studies Depression Scale From Baseline to Post-Intervention.

The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report questionnaire for assessing symptoms associated with depression. Response options range from 0 ("Rarely or None of the Time") to 3 ("Most or Almost All the Time"). Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. The among-group differences in the change scores are compared by ANOVA.

Change in the Center for Epidemiologic Studies Depression Scale From Baseline to Follow-up.

The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report questionnaire for assessing symptoms associated with depression. Response options range from 0 ("Rarely or None of the Time") to 3 ("Most or Almost All the Time"). Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. The among-group differences in the change scores are compared by ANOVA.

Change in the Connor-Davidson Resilience Scale From Baseline to Post-Intervention

The Connor-Davidson Resilience Scale (CD RISC) is a 25-item self-report measure of resilience when faced with difficulties. Respondents are presented with a series of statements and asked how much the statements apply to them. Responses range from 0 ("Not at all true") to 4 ("True nearly all the time"). Responses are summed to range from 0 to 100. Higher scores indicate more resilience. The among-group differences in the change scores are compared by ANOVA.

Change in the Connor-Davidson Resilience Scale From Baseline to Post-Intervention

The Connor-Davidson Resilience Scale (CD RISC) is a 25-item self-report measure of resilience when faced with difficulties. Respondents are presented with a series of statements and asked how much the statements apply to them. Responses range from 0 ("Not at all true") to 4 ("True nearly all the time"). Responses are summed to range from 0 to 100. Higher scores indicate more resilience. The among-group differences in the change scores are compared by ANOVA.

Change in the Mental Health Quality of Life Baseline to Post-Intervention

Mental Health Quality of Life Total Score: Mental Health Quality of Life (MHQoL) is an 8-item self-report questionnaire. The Mental Health Quality of Life Total Score is calculated as a sum of the first 7 items (self-image, independence, mood, relationships, daily activities, physical health, and future), with response levels ranging from 0 ("Very dissatisfied") to 3 ("Very satisfied"). The total score has a range of 0-21. Higher scores indicate better quality of life.

The among-group difference in the change scores for both are compared by ANOVA.

Change in the Mental Health Quality of Life Baseline to Follow-up

Mental Health Quality of Life Total Score: Mental Health Quality of Life (MHQoL) is an 8-item self-report questionnaire. The Mental Health Quality of Life Total Score is calculated as a sum of the first 7 items (self-image, independence, mood, relationships, daily activities, physical health, and future), with response levels ranging from 0 ("Very dissatisfied") to 3 ("Very satisfied"). The total score has a range of 0-21. Higher scores indicate better quality of life.

The among-group difference in the change scores for both are compared by ANOVA.

Change in the Problem-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention

The Problem-focused coping subscale of the Coping Orientation to Problems Experienced Inventory is an 8-item, self-report subscale. Problem-focused coping refers to using informational support, planning, and positive reframing. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater problem-focused coping.

Change in the Emotion-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention

The Emotion-focused coping subscale of the Coping Orientation to Problems Experienced Inventory in a 12-item, self-report subscale. Emotion-focused coping refers to using venting, emotional support, humor, acceptance, self-blame, and religion. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater emotion-focused coping.

Change in the Avoidant Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Post-intervention

The avoidant-focused coping subscale of the Coping Orientation to Problems Experienced Inventory is an 8-item, self-report subscale. Avoidant coping refers to using self-distraction, denial, substance use, and behavioral disengagement. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater avoidant coping.

Change in the Problem-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up

The Problem-focused coping subscale of the Coping Orientation to Problems Experienced Inventory is an 8-item, self-report subscale. Problem-focused coping refers to using informational support, planning, and positive reframing. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater problem-focused coping.

Change in the Emotion-focused Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up

The Emotion-focused coping subscale of the Coping Orientation to Problems Experienced Inventory in a 12-item, self-report subscale. Emotion-focused coping refers to using venting, emotional support, humor, acceptance, self-blame, and religion. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater emotion-focused coping.

Change in the Avoidant Coping Subscale of the Coping Orientation to Problems Experienced Inventory From Baseline to Follow-up

The avoidant-focused coping subscale of the Coping Orientation to Problems Experienced Inventory is an 8-item, self-report subscale. Avoidant coping refers to using self-distraction, denial, substance use, and behavioral disengagement. Respondents rate the degree to which they have been using a coping style based on a series of statements with responses of 1 ("I haven't been doing this at all") to 4 ("I've been doing this a lot". Scores are averaged across items and range from 1-4. Higher scores indicate greater avoidant coping.

Change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance 8b Short Form T-score, Baseline to Post-intervention.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8b Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration over the past 7 days. This instrument includes 8 items rated on a 5-point Likert scale (1 = not at all to 5 = very much). Raw scores are summed and converted to standardized T-scores based on the PROMIS adult reference population. T-scores have a mean of 50 and a standard deviation of 10, where 50 represents the average level of sleep disturbance in the general U.S. population.

Higher T-scores indicate greater sleep disturbance (worse outcome), while lower T-scores indicate less sleep disturbance (better outcome). Clinically, T-scores of approximately 60 or higher are considered indicative of elevated sleep disturbance, and scores of 70 or higher may reflect severe sleep disturbance.

Change in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance 8b Short Form T-score, Baseline to Follow-up.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8b Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration over the past 7 days. This instrument includes 8 items rated on a 5-point Likert scale (1 = not at all to 5 = very much). Raw scores are summed and converted to standardized T-scores based on the PROMIS adult reference population. T-scores have a mean of 50 and a standard deviation of 10, where 50 represents the average level of sleep disturbance in the general U.S. population.

Higher T-scores indicate greater sleep disturbance (worse outcome), while lower T-scores indicate less sleep disturbance (better outcome). Clinically, T-scores of approximately 60 or higher are considered indicative of elevated sleep disturbance, and scores of 70 or higher may reflect severe sleep disturbance.

Change in the Short Form Health Survey (SF-12), Baseline to Post-intervention

The Short Form Health Survey (SF-12) is a 12-item self-report questionnaire that assesses aspects of physical health and mental well-being. Scoring is complex and includes both positive and negatively worded items and is translated into a score of 0-100. Higher scores indicate better physical and mental health functioning.

Proportion of Participants Who Completed the Study

Retention will be compared between the active intervention arms and is defined as the number of individuals randomized who did not withdraw from the study or were administratively censored.

Proportion of Participants Who Complete the Intervention

Completers are defined as randomized participants who either attend a minimum of 5 classes (MTIA arm) or view material for a minimum of 5 weeks in the MAPP. The proportion of completers will be compared between groups.

Client Satisfaction Questionnaire-internet at the End of the Intervention

The Client satisfaction questionnaire-internet (CSQ-I) is an 8-item measure developed in Germany to assess satisfaction with telehealth interventions. the CSQ-I consists of seven statements that address satisfaction with an online program and willingness to refer others. The investigators have adjusted the 4 response categories for an American sample to use the standard agreement scale (1=strongly disagree, 2= mildly disagree, 3=mildly agree, 4= strongly agree). Mean scores are calculated which can range from 1-4 with higher scores representing greater satisfaction. The questionnaire will be assessed among participants in the intervention arms at the end of the interventions.