SMILE: 新型コロナウイルス感染症流行中の人種および民族集団への介入としてマインドフルネスを評価する臨床試験 (SMILE)

アクティブコンパレータ：「MTIA」介入

マインドフルネス トレーニング インストラクター管理 (「MTIA」) の介入には、次の要素が組み込まれます: 8 週間、1 週間あたり 90 分の修正マインドフルネス プログラムでのトレーニング。これにより、人種/民族グループに関連した実行可能なトレーニングにさらに重点が置かれます。 a) ストレスとの関連性、対処法、回復力に関する教訓、b) 自分自身と他人に対する思いやりのある思いやり。 c) 非言語的なマインドフルネス、マインドフルなリスニング、マインドフルなスピーキングなどのマインドフルなコミュニケーション。 MTIA は、インストラクター主導、インターネット配信 (Zoom 経由)、インタラクティブなグループベースのマインドフルネス トレーニング介入であり、セッション外の課題を伴うグループ形式で約 9 名を対象としたトレーニングが組み込まれます。

行動：マインドフルネス

マインドフルネス瞑想は、過去や未来に関する考え（単純なイメージであれ、複雑なストーリーラインであれ）への認知的固着の解放と組み合わせて、現在の瞬間の経験への注意を意図的に自己調整する行動テクニックとして説明されています。 マインドフルネスのトレーニングを通じて、人は現時点の認識の非判断的な状態を呼び起こし、維持することを学びます。

アクティブコンパレータ：「MAPP」介入

マインドフルネスAPP (「MAPP」) は、SMILE 研究チームによって開発された自己管理型介入です。 MAPP は個人使用を目的としており、MTIA セッションに対応するマインドフルネスの演習と教訓で構成される 8 つの MAPP セッションが含まれています。 MTIA の毎週のクラスの長さは 90 分であるため、MAPP の課題では、割り当てられたレッスンをカバーするために週に約 90 分を費やすことが推奨されますが、参加者にとって都合のよい柔軟な形式で行われます。 さらに、各セッションには、通常 1 日あたり 10 ～ 30 分のマインドフルネスに基づいた練習課題が含まれます。 完了までに推奨される合計日数は 49 日となり、従来の 8 週間の MTIA セッションの開始から終了までの時間に匹敵します。ただし、この個別プログラムには柔軟性があります。

行動：マインドフルネス

マインドフルネス瞑想は、過去や未来に関する考え（単純なイメージであれ、複雑なストーリーラインであれ）への認知的固着の解放と組み合わせて、現在の瞬間の経験への注意を意図的に自己調整する行動テクニックとして説明されています。 マインドフルネスのトレーニングを通じて、人は現時点の認識の非判断的な状態を呼び起こし、維持することを学びます。

介入なし：順番待ちリストの制御

待機リスト コントロール (WLC) グループはすべての研究評価セッションに参加しますが、研究での役割が完了するまでマインドフルネス介入は提供されません。

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.

簡易健康調査 (SF-12) の変更点、ベースラインからフォローアップまで

簡易健康調査 (SF-12) は、身体的健康と精神的健康の側面を評価する 12 項目の自己申告式アンケートです。 スコアリングは複雑で、肯定的な表現と否定的な表現の両方の項目が含まれており、0 ～ 100 のスコアに変換されます。 スコアが高いほど、身体的および精神的健康機能が良好であることを示します。

新型コロナウイルス感染症（COVID-19）ストレススケールのベースラインの介入後への変化

新型コロナウイルス感染症ストレススケール（短縮版）は、過去 7 日間の新型コロナウイルス関連の不安を測定するために設計された 18 項目の自己申告アンケートです。 相関性の高い 3 つの下位尺度 (危険、汚染、外傷性ストレス) が測定されます。 危険性と汚染の下位尺度では、ウイルスに関連する懸念について 0 (「まったくない」) から 4 (「非常に」) の範囲の回答カテゴリーで尋ねます。 心的外傷性ストレスの下位尺度は症状の頻度を尋ねるもので、0 (「まったくない」) から 4 (「ほぼ常に」) まで変化します。 回答は下位スケール全体で 0 ～ 72 の範囲で合計され、値が大きいほど新型コロナウイルス関連のストレスが大きいことを示します。 下位尺度のうち 2 つ、新型コロナウイルスに関連する強迫的検査と外国人排斥は関連性がなくなったため、含まれていません。

新型コロナウイルス感染症（COVID-19）ストレススケールのベースラインからフォローアップまでの変更

新型コロナウイルス感染症ストレススケール（短縮版）は、過去 7 日間の新型コロナウイルス関連の不安を測定するために設計された 18 項目の自己申告アンケートです。 相関性の高い 3 つの下位尺度 (危険、汚染、外傷性ストレス) が測定されます。 危険性と汚染の下位尺度では、ウイルスに関連する懸念について 0 (「まったくない」) から 4 (「非常に」) の範囲の回答カテゴリーで尋ねます。 心的外傷性ストレスの下位尺度は症状の頻度を尋ねるもので、0 (「まったくない」) から 4 (「ほぼ常に」) まで変化します。 回答は下位スケール全体で 0 ～ 72 の範囲で合計され、値が大きいほど新型コロナウイルス関連のストレスが大きいことを示します。 下位尺度のうち 2 つ、新型コロナウイルスに関連する強迫的検査と外国人排斥は関連性がなくなったため、含まれていません。

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.