SMILE: Klinická studie k vyhodnocení všímavosti jako intervence pro rasovou a etnickou populaci během COVID-19 (SMILE)

Aktivní komparátor: Zásah "MTIA".

Intervence řízená instruktorem tréninku všímavosti ("MTIA") bude zahrnovat následující prvky: trénink v 8týdenním 90minutovém týdnu, upravený program všímavosti, který klade další důraz na školení, které je proveditelné a relevantní pro rasové/etnické skupiny , včetně: a) didaktiky relevance ke stresu, zvládání a odolnosti, b) všímavého soucitu se sebou samým a ostatními; c) všímavá komunikace, včetně neverbální všímavosti, všímavého naslouchání a všímavého mluvení. MTIA bude probíhat pod vedením instruktora, bude doručován internetem (prostřednictvím Zoom), interaktivní, skupinový trénink všímavosti, který bude zahrnovat školení pro přibližně 9 osob ve skupinovém formátu s úkoly mimo zasedání.

Behaviorální: Všímavost

Meditace všímavosti byla popsána jako behaviorální technika zahrnující záměrnou seberegulaci pozornosti vůči prožívání přítomného okamžiku v kombinaci s uvolněním kognitivní fixace na myšlenky (ať už jde o jednoduché obrázky nebo složité příběhy) týkající se minulosti nebo budoucnosti. Prostřednictvím tréninku všímavosti se jednotlivci učí vyvolávat a udržovat nesoudící stav vědomí přítomného okamžiku.

Aktivní komparátor: Zásah "MAPP".

MindfulnessAPP ("MAPP") je intervence, kterou si sám spravoval, vyvinutou studijním týmem SMILE. MAPP je pro individuální použití, s osmi lekcemi MAPP složenými z cvičení všímavosti a didaktiky, které odpovídají relacím MTIA. Vzhledem k tomu, že týdenní lekce MTIA bude trvat 90 minut, úkoly MAPP doporučí strávit přibližně 90 minut týdně pokrytím zadané lekce, ale ve flexibilním formátu vhodném pro účastníka. Kromě toho bude každé sezení obsahovat praktické úkoly založené na všímavosti, které se obvykle pohybují od 10 do 30 minut denně. Celkový počet navrhovaných dnů pro dokončení bude 49 dnů, srovnatelný s časem od začátku do konce tradičního 8týdenního sezení MTIA; v rámci tohoto individualizovaného programu však bude flexibilita.

Behaviorální: Všímavost

Meditace všímavosti byla popsána jako behaviorální technika zahrnující záměrnou seberegulaci pozornosti vůči prožívání přítomného okamžiku v kombinaci s uvolněním kognitivní fixace na myšlenky (ať už jde o jednoduché obrázky nebo složité příběhy) týkající se minulosti nebo budoucnosti. Prostřednictvím tréninku všímavosti se jednotlivci učí vyvolávat a udržovat nesoudící stav vědomí přítomného okamžiku.

Žádný zásah: Ovládání čekací listiny

Skupina WLC (Wait-list Control) se zúčastní všech schůzí hodnocení výzkumu, ale intervence všímavosti jí nebude nabídnuta, dokud nebude dokončena jejich role ve výzkumu.

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.

Změna ve Short Form Health Survey (SF-12), Baseline to Follow-up

Short Form Health Survey (SF-12) je 12-položkový dotazník, který hodnotí aspekty fyzického zdraví a duševní pohody. Bodování je složité a zahrnuje pozitivně i negativně formulované položky a je převedeno do skóre 0-100. Vyšší skóre ukazuje na lepší fungování fyzického a duševního zdraví.

Změna základní škály stresu COVID-19 na pozásahovou

Stresová škála COVID-19 (zkrácená) je 18položkový dotazník pro sebereportování, který je navržen tak, aby změřil úzkost související s COVID za posledních 7 dní. Měří se tři vysoce korelované subškály: Nebezpečí, Kontaminace a Traumatický stres. Subškály Nebezpečí a Kontaminace se ptají na obavy související s virem s kategoriemi odpovědí od 0 („Vůbec ne“) do 4 („Extrémně). Subškála Traumatický stres se ptá na frekvenci příznaků a pohybuje se od 0 („Nikdy“) do 4 („Téměř vždy“). Odpovědi se sčítají napříč subškálami pro rozsah 0–72, přičemž vyšší hodnoty indikují větší stres související s COVID. Dvě ze subškál, kompulzivní kontrola a xenofobie související s COVID, již nejsou relevantní a nejsou zahrnuty.

Změna základní čáry zátěžové škály COVID-19 na sledování

Stresová škála COVID-19 (zkrácená) je 18položkový dotazník pro sebereportování, který je navržen tak, aby změřil úzkost související s COVID za posledních 7 dní. Měří se tři vysoce korelované subškály: Nebezpečí, Kontaminace a Traumatický stres. Subškály Nebezpečí a Kontaminace se ptají na obavy související s virem s kategoriemi odpovědí od 0 („Vůbec ne“) do 4 („Extrémně). Subškála Traumatický stres se ptá na frekvenci příznaků a pohybuje se od 0 („Nikdy“) do 4 („Téměř vždy“). Odpovědi se sčítají napříč subškálami pro rozsah 0–72, přičemž vyšší hodnoty indikují větší stres související s COVID. Dvě ze subškál, kompulzivní kontrola a xenofobie související s COVID, již nejsou relevantní a nejsou zahrnuty.

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.