SMILE: 코로나19 기간 동안 인종 및 민족 집단에 대한 중재로서 마음챙김을 평가하기 위한 임상 시험 (SMILE)

활성 비교기: "MTIA" 개입

Mindfulness Training Instructor Administered("MTIA") 중재에는 다음 요소가 포함됩니다: 8주, 주당 90분 훈련, 수정된 마음챙김 프로그램, 실행 가능하고 인종/민족 그룹과 관련된 훈련에 추가 강조 a) 스트레스, 대처 및 회복력과의 관련성에 대한 교훈, b) 자신과 타인에 대한 마음챙김 연민; c) 비언어적 마음챙김, 마음챙김 듣기, 마음챙김 말하기를 포함한 마음챙김 의사소통. MTIA는 강사 주도형, 인터넷 제공(Zoom을 통해), 대화형, 그룹 기반 마음챙김 교육 중재로, 세션 외부 과제와 함께 그룹 형식으로 약 9명을 위한 교육을 통합합니다.

행동: 마음챙김

마음챙김 명상은 과거나 미래에 관한 생각(단순한 이미지든 복잡한 스토리 라인이든)에 대한 인지적 집착의 방출과 결합하여 현재 순간의 경험에 대한 의도적인 자기 조절과 관련된 행동 기법으로 설명되어 왔습니다. 마음챙김 훈련을 통해 개인은 현재 순간의 인식에 대한 비판단적 상태를 불러일으키고 유지하는 방법을 배웁니다.

활성 비교기: "MAPP" 개입

MindfulnessAPP("MAPP")는 SMILE 연구 팀이 개발한 자가 관리 개입입니다. MAPP는 MTIA 세션에 해당하는 마음챙김 연습과 교훈으로 구성된 8개의 MAPP 세션으로 구성된 개인용입니다. MTIA 주간 수업의 길이는 90분이므로 MAPP 과제에서는 지정된 수업을 다루는 데 주당 약 90분을 할애할 것을 권장하지만 참가자에게 편리한 유연한 형식을 사용합니다. 또한 각 세션에는 일반적으로 하루 10~30분 범위의 마음챙김 기반 연습 과제가 포함됩니다. 완료를 위해 권장되는 총 일수는 49일이며 이는 기존 8주 MTIA 세션의 시작부터 끝까지 소요되는 시간과 비슷합니다. 그러나 이 개별화된 프로그램에는 유연성이 있습니다.

행동: 마음챙김

마음챙김 명상은 과거나 미래에 관한 생각(단순한 이미지든 복잡한 스토리 라인이든)에 대한 인지적 집착의 방출과 결합하여 현재 순간의 경험에 대한 의도적인 자기 조절과 관련된 행동 기법으로 설명되어 왔습니다. 마음챙김 훈련을 통해 개인은 현재 순간의 인식에 대한 비판단적 상태를 불러일으키고 유지하는 방법을 배웁니다.

간섭 없음: 대기자 명단 통제

대기자 명단 관리(WLC) 그룹은 모든 연구 평가 세션에 참여하지만 연구에서 자신의 역할이 완료될 때까지 마음챙김 중재가 제공되지 않습니다.

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.

약식 건강 설문조사(SF-12), 기준선에서 후속 조치로의 변경

약식 건강 설문조사(SF-12)는 신체 건강과 정신적 웰빙 측면을 평가하는 12개 항목으로 구성된 자가 보고 설문지입니다. 채점은 복잡하며 긍정적인 단어와 부정적인 단어가 모두 포함되며 0-100점으로 환산됩니다. 점수가 높을수록 신체적, 정신적 건강 기능이 더 좋다는 것을 의미합니다.

코로나19 스트레스 척도 기준을 개입 후로 변경

코로나19 스트레스 척도(축약형)는 지난 7일 동안의 코로나19 관련 불안을 측정하기 위해 고안된 18개 항목의 자가 보고 설문지입니다. 위험, 오염, 외상성 스트레스 등 세 가지 상관 관계가 높은 하위 척도가 측정됩니다. 위험 및 오염 하위 척도는 0(“전혀 그렇지 않음”)부터 4(“매우 심함) 범위의 응답 범주를 통해 바이러스와 관련된 우려 사항에 대해 질문합니다. 외상성 스트레스 하위 척도는 증상의 빈도를 묻고 0("전혀 없음")부터 4("거의 항상")까지 다양합니다. 응답은 0~72 범위의 하위 척도에 걸쳐 합산되며, 값이 높을수록 코로나 관련 스트레스가 더 크다는 것을 나타냅니다. COVID와 관련된 두 가지 하위 척도인 강박 검사와 외국인 혐오증은 더 이상 관련이 없으며 포함되지 않습니다.

후속 조치를 위한 COVID-19 스트레스 척도 기준 변경

코로나19 스트레스 척도(축약형)는 지난 7일 동안의 코로나19 관련 불안을 측정하기 위해 고안된 18개 항목의 자가 보고 설문지입니다. 위험, 오염, 외상성 스트레스 등 세 가지 상관 관계가 높은 하위 척도가 측정됩니다. 위험 및 오염 하위 척도는 0(“전혀 그렇지 않음”)부터 4(“매우 심함) 범위의 응답 범주를 통해 바이러스와 관련된 우려 사항에 대해 질문합니다. 외상성 스트레스 하위 척도는 증상의 빈도를 묻고 0("전혀 없음")부터 4("거의 항상")까지 다양합니다. 응답은 0~72 범위의 하위 척도에 걸쳐 합산되며, 값이 높을수록 코로나 관련 스트레스가 더 크다는 것을 나타냅니다. COVID와 관련된 두 가지 하위 척도인 강박 검사와 외국인 혐오증은 더 이상 관련이 없으며 포함되지 않습니다.

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.