<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04498442</url>
  </required_header>
  <id_info>
    <org_study_id>2020P000433</org_study_id>
    <nct_id>NCT04498442</nct_id>
  </id_info>
  <brief_title>A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls</brief_title>
  <official_title>A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a randomized controlled trail with an observational arm and aims at collecting&#xD;
      information on the prevalence of COVID 19 infection in seasoned yoga practitioners by&#xD;
      comparing it with the prevalence of COVID-19 infection prevalence rates among age and gender&#xD;
      matched control participants who do not practice yoga.&#xD;
&#xD;
      The study hypothesizes that yoga practice promotes protection and enhances recovery from the&#xD;
      COVID-19 infection. To prove the hypothesis, the study investigators are collecting and&#xD;
      comparing responses from seasoned yoga practitioners to age and gender matched controls&#xD;
      participants (who do not practice yoga routinely) regarding their recovery from the COVID 19&#xD;
      infection. Based on validated questionnaires on perceived stress, anxiety, depression,&#xD;
      well-being, mindfulness, joy disposition, and resilience in participants over the study&#xD;
      duration, the investigators also collect information on participant's mental and emotional&#xD;
      predispositions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Globally, COVID-19 has resulted in more than 3 million confirmed cases with a continuing rise&#xD;
      in numbers. Following the first case detection in the United States on January 20, 2020,&#xD;
      there has been a steady rise in the reported cases resulting in all 50 states being affected&#xD;
      by the disease. As of April 28, 2020, two million deaths globally have been attributed to&#xD;
      this disease. This is an ongoing pandemic, and our understanding of it is continually&#xD;
      evolving.&#xD;
&#xD;
      Measures such as social distancing and working remotely have been enforced worldwide to curb&#xD;
      disease transmission. This has led to an increased number of people staying indoors and&#xD;
      living a more sedentary lifestyle. Many clinicians and people in the community have raised&#xD;
      concerns about maintaining good mental and emotional health along with physical health.&#xD;
&#xD;
      Amidst concerns for maintenance of holistic health, yoga in its forms of guided breathing,&#xD;
      meditation, and mindfulnessare interventions people are practicing rigorously in the current&#xD;
      times of uncertainty. These interventions require no external infrastructure, promote a sense&#xD;
      of calm and well-being, improve sleep quality, and reduce stress and anxiety.&#xD;
&#xD;
      Need for the study:&#xD;
&#xD;
      The study aims at collecting information on the prevalence of COVID 19 infection in seasoned&#xD;
      yoga practitioners and comparing it with the prevalence of COVID-19 infection prevalence&#xD;
      rates among age and gender matched control participants.&#xD;
&#xD;
      The study hypothesizes that yoga practice promotes protection and enhances recovery from the&#xD;
      COVID-19 infection. To prove the hypothesis, the study investigators intend to collect and&#xD;
      compare responses from seasoned yoga practitioners and age and gender matched controls&#xD;
      regarding their recovery from the COVID 19 infection. Based on validated questionnaires on&#xD;
      perceived stress, anxiety, depression, well-being, mindfulness, joy disposition, and&#xD;
      resilience in participants over the study duration, the study investigators also intend to&#xD;
      collect information on participant's mental and emotional predispositions.&#xD;
&#xD;
      Through this Randomized Controlled Trial, the following specific aims are to be accomplished:&#xD;
&#xD;
      Specific Aim 1: To compare prevalence rates of diagnosed COVID-19 infection between the&#xD;
      seasoned yoga practitioners and age and gender matched controls at baseline and at 6 and 12&#xD;
      weeks.&#xD;
&#xD;
      Specific Aim 2: To Compare Protection and Recovery from COVID 19 infection between seasoned&#xD;
      yoga practitioners and controls as demonstrated by:&#xD;
&#xD;
        1. Self-reported duration of fever and respiratory symptoms in COVID-19 positive&#xD;
           participants&#xD;
&#xD;
        2. Self-reported readiness to return to work (or a feeling of being physically and mentally&#xD;
           fit) This is the key secondary outcome of the study.&#xD;
&#xD;
      Specific aim 3: To quantitatively assess the effects of yoga practices between seasoned&#xD;
      practitioners and the control groups on measures such as perceived stress, resilience, and&#xD;
      overall wellbeing by use of validated scales.&#xD;
&#xD;
      We also aim to do exploratory analysis by comparing the different yoga practices and their&#xD;
      duration between the 3 study groups to establish a dose-response curve if possible.&#xD;
&#xD;
      Note: The term &quot;yoga&quot; used throughout this document is defined as mindfulness practices which&#xD;
      involve deep breathing exercises and meditation, and excludes strenuous physical exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Actual">October 22, 2020</completion_date>
  <primary_completion_date type="Actual">October 22, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>In this prospective randomized control trial, the effects of yoga practices are being compared between seasoned yoga practitioners with two controls who are age and gender matched and living in the same neighborhood.&#xD;
One control group acts as active control who receives active intervention in the form of yoga activities during the study duration. The study provides its active control group an opportunity to learn and practice Simha-Kriya which involves deep breathing exercises and meditation. In contrast, the other control group acts as a placebo control and performs either reading activities or remains idle for 15 minutes throughout the study period.&#xD;
The participants will be requested to complete a set of surveys as a part of the research activity. These surveys include validated scales on stress, resilience and well-being; and objective questions on COVID-19 infection and medical history.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Perceived Stress Levels</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks.</time_frame>
    <description>The study aims to evaluate changes in perceived levels of stress in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Perceived Stress Scale. The scale measures the degree to which situations in participant's life are appraised as stressful. This is the primary outcome for our study. We assess for change in perceived stress levels by analyzing the PSS score for each participant and comparing it to pre &amp; post intervention results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Resilience Levels</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>The study aims to evaluate changes in resilience levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Brief Resilience Scale. The scale identifies the individual's ability to bounce back or recover from a stress. This is the key secondary outcome for our study. We assess for change in resilience levels by analyzing the 6-item BRS, which computes a score for each participant by dividing total score obtained/number of questions responded; (range 6-30) and comparing it to pre &amp; post intervention results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Covid-19 Prevalence</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>The study aims to evaluate changes in Covid-19 prevalence in survey participants and the effect yoga or reading a book has over them. Based on the reported number of cases in the participant cohort we compute Period Prevalence for 3 specified time points. We assess for change in reported prevalence and stratify the results to match with region-wise prevalence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-reported duration of fever and respiratory symptoms in COVID-19 positive participants</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>The study aims to evaluate changes in self-reported duration of fever and respiratory symptoms in Covid-19 positive survey participants and the effect yoga or reading a book has over them. Based on the reported number of positive cases in the participant cohort we compare the frequency of duration between the two cohorts i.e. yoga practitioners and control; followed by a comparison between the two control groups viz: yoga group vs idle group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-reported readiness to return to work in COVID-19 positive participants</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>The study aims to evaluate changes in self-reported readiness to return to work in Covid-19 positive survey participants and the effect yoga or reading a book has over them. Based on the reported number of positive cases in the participant cohort we compare the frequency of readiness between the two cohorts i.e. yoga practitioners and control; followed by a comparison between the two control groups viz: yoga group vs idle group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in Mindfulness</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>We assessed for change in Mindfulness levels in all participants by using a short form of the validated scale for this purpose namely, Mindfulness Attention Awareness Scale (MAAS). The scale measures the individuals' ability for receptive awareness and attention to present. We compute the MAAS scores for each participant which is a mean score for 5 item questionnaires and compare the pre &amp; post intervention results to look for change.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Dispositional Positive Emotions Scale (DPES- Joy subscale)</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>We assess for change in the individuals' ability to feel joy and look for it in the mundane by using a validated scale for this purpose namely, Dispositional Positive Emotions Scale (DPES) particularly the Joy subscale. The Sub-scale measures the individuals' dispositional ability to feel joy in life. We compute the DPES-JOY subscale scores for each participant which is a mean score for 6 item questionnaires and compare the pre &amp; post intervention results to look for change.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in 4 Item-Patient Health Questionnaire measuring Anxiety and Depression (PHQ-4) levels</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>The study aims to evaluate changes in anxiety and depression levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, 4 Item-Patient Health Questionnaire measuring Anxiety and Depression (PHQ-4) Scale. The 4 question scale screens for anxiety and depression in participants by computing sum for the responses (scores range: 0-12) and comparing it to pre &amp; post intervention results.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in well being levels</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>The study aims to evaluate changes in wellbeing levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Warwick- Edinburgh Wellbeing Scale (WEMWBS). The scale identifies the individual's aspects of mental health such as: positive affect, satisfying interpersonal relationship and positive functioning. We assess for change in 14 item well-being levels by analyzing the total WEMWBS score for each participant and comparing it to pre &amp; post intervention results.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Post Traumatic Growth Inventory (PTGI) scores</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks</time_frame>
    <description>The purpose of the growth inventory is to capture the positive outcomes reported by a person who have experienced a traumatic event. This scale collects information from only those participants who identify as being hospitalized during the COVID-19 pandemic and look for their coping ability to the aftermath of the trauma. This 21 item scale is rated on a 6-point Likert response scale. Response from each of the 6 question is then summed to create a total PTGI score.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8519</enrollment>
  <condition>Covid19</condition>
  <condition>Stress</condition>
  <condition>Anxiety Depression</condition>
  <arm_group>
    <arm_group_label>Yoga Practitioners</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Yoga practitioners arm is the observational arm of the study, wherein participants who follow Isha school of yoga and have completed either of the three courses : Inner Engineering Online (IEO), Inner Engineering Completion (Shambhavi Mahamudra kriya) or Shakthi Chalana Kriya can be included in this group. The participant are advised to continue with their routine yoga practice with no change in the duration of practice or frequency of their practices. Participants of this group have expertise in yoga practice and have been practicing yoga for more than 6 weeks before study enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Yoga</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control Yoga is the active comparator arm of the study. Participants who are randomly allocated to this group, practice &quot;Simha Kriya&quot;, a deep breathing exercise taught by the Isha School of yoga.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Idle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control Idle is the active comparator arm of the study. Participants who are randomly allocated to this group, are advised to either read a book for 15 minutes each day or sit idle for 15 minutes. This is the true control group for the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Simha Kriya</intervention_name>
    <description>Simha-Kriya involves deep breathing exercises and meditation. It is the practice of extending the breath, expanding our lung capacity and mental concentration and energizing the body. Simha Kriya, when practiced intentionally will unite the mental, physical, and spiritual body through the breath. For the purpose of this study we advocate practice of Simha Kriya at least once a day.</description>
    <arm_group_label>Control Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reading a Book</intervention_name>
    <description>Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. Reading a book is often inculcated into mindfulness research due to it's impact on the personality and attitude. The simple act of reading a book can have a significant impact on their attitudes and can help them cope better with stress. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely for 15 minutes each day. Reading a book could potentially be substituted with sitting idle for 15 minutes if participants wishes to.</description>
    <arm_group_label>Control Idle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Seasoned Yoga practitioners:&#xD;
&#xD;
          -  Participants must be a follower of Isha school of yoga&#xD;
&#xD;
          -  Must have completed Inner Engineering Online course/ practice Shambhavi Mahamudra&#xD;
             Kriya/ Shakthi Chalana Kriya&#xD;
&#xD;
          -  Interest in participating in the study&#xD;
&#xD;
        For Controls:&#xD;
&#xD;
          -  Participants has little to no experience with Isha school of yoga&#xD;
&#xD;
          -  Should have practiced yoga routinely for &lt; 1 Month (if previously experienced in yoga)&#xD;
&#xD;
          -  Interest in participating in the study&#xD;
&#xD;
          -  Age ( +/- 3 years) matched with the seasoned practitioner&#xD;
&#xD;
          -  Gender matched with seasoned practitioner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For both groups:&#xD;
&#xD;
          -  Participants &lt; 18 years of age&#xD;
&#xD;
          -  Participant &gt; 80 years of age&#xD;
&#xD;
          -  Participants must be able to read and understand English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Balachundhar Subramaniam, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Centre</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Balachundhar Subramaniam</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>covid-19</keyword>
  <keyword>yoga</keyword>
  <keyword>stress</keyword>
  <keyword>anxiety</keyword>
  <keyword>depression</keyword>
  <keyword>well being</keyword>
  <keyword>resilience</keyword>
  <keyword>breathing exercises</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498442
org study id: 2020P000433
nct id: NCT04498442
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a randomized controlled trail with an observational arm and aims at collecting
      information on the prevalence of COVID 19 infection in seasoned yoga practitioners by
      comparing it with the prevalence of COVID-19 infection prevalence rates among age and gender
      matched control participants who do not practice yoga.

      The study hypothesizes that yoga practice promotes protection and enhances recovery from the
      COVID-19 infection. To prove the hypothesis, the study investigators are collecting and
      comparing responses from seasoned yoga practitioners to age and gender matched controls
      participants (who do not practice yoga routinely) regarding their recovery from the COVID 19
      infection. Based on validated questionnaires on perceived stress, anxiety, depression,
      well-being, mindfulness, joy disposition, and resilience in participants over the study
      duration, the investigators also collect information on participant's mental and emotional
      predispositions.
Background:

      Globally, COVID-19 has resulted in more than 3 million confirmed cases with a continuing rise
      in numbers. Following the first case detection in the United States on January 20, 2020,
      there has been a steady rise in the reported cases resulting in all 50 states being affected
      by the disease. As of April 28, 2020, two million deaths globally have been attributed to
      this disease. This is an ongoing pandemic, and our understanding of it is continually
      evolving.

      Measures such as social distancing and working remotely have been enforced worldwide to curb
      disease transmission. This has led to an increased number of people staying indoors and
      living a more sedentary lifestyle. Many clinicians and people in the community have raised
      concerns about maintaining good mental and emotional health along with physical health.

      Amidst concerns for maintenance of holistic health, yoga in its forms of guided breathing,
      meditation, and mindfulnessare interventions people are practicing rigorously in the current
      times of uncertainty. These interventions require no external infrastructure, promote a sense
      of calm and well-being, improve sleep quality, and reduce stress and anxiety.

      Need for the study:

      The study aims at collecting information on the prevalence of COVID 19 infection in seasoned
      yoga practitioners and comparing it with the prevalence of COVID-19 infection prevalence
      rates among age and gender matched control participants.

      The study hypothesizes that yoga practice promotes protection and enhances recovery from the
      COVID-19 infection. To prove the hypothesis, the study investigators intend to collect and
      compare responses from seasoned yoga practitioners and age and gender matched controls
      regarding their recovery from the COVID 19 infection. Based on validated questionnaires on
      perceived stress, anxiety, depression, well-being, mindfulness, joy disposition, and
      resilience in participants over the study duration, the study investigators also intend to
      collect information on participant's mental and emotional predispositions.

      Through this Randomized Controlled Trial, the following specific aims are to be accomplished:

      Specific Aim 1: To compare prevalence rates of diagnosed COVID-19 infection between the
      seasoned yoga practitioners and age and gender matched controls at baseline and at 6 and 12
      weeks.

      Specific Aim 2: To Compare Protection and Recovery from COVID 19 infection between seasoned
      yoga practitioners and controls as demonstrated by:

        1. Self-reported duration of fever and respiratory symptoms in COVID-19 positive
           participants

        2. Self-reported readiness to return to work (or a feeling of being physically and mentally
           fit) This is the key secondary outcome of the study.

      Specific aim 3: To quantitatively assess the effects of yoga practices between seasoned
      practitioners and the control groups on measures such as perceived stress, resilience, and
      overall wellbeing by use of validated scales.

      We also aim to do exploratory analysis by comparing the different yoga practices and their
      duration between the 3 study groups to establish a dose-response curve if possible.

      Note: The term "yoga" used throughout this document is defined as mindfulness practices which
      involve deep breathing exercises and meditation, and excludes strenuous physical exercise.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this prospective randomized control trial, the effects of yoga practices are being compared between seasoned yoga practitioners with two controls who are age and gender matched and living in the same neighborhood.
One control group acts as active control who receives active intervention in the form of yoga activities during the study duration. The study provides its active control group an opportunity to learn and practice Simha-Kriya which involves deep breathing exercises and meditation. In contrast, the other control group acts as a placebo control and performs either reading activities or remains idle for 15 minutes throughout the study period.
The participants will be requested to complete a set of surveys as a part of the research activity. These surveys include validated scales on stress, resilience and well-being; and objective questions on COVID-19 infection and medical history.
primary purpose: Other
masking: None (Open Label)
measure: Change in Perceived Stress Levels
time frame: Baseline, 6 weeks and 12 weeks.
description: The study aims to evaluate changes in perceived levels of stress in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Perceived Stress Scale. The scale measures the degree to which situations in participant's life are appraised as stressful. This is the primary outcome for our study. We assess for change in perceived stress levels by analyzing the PSS score for each participant and comparing it to pre & post intervention results.
measure: Changes in Resilience Levels
time frame: Baseline, 6 weeks and 12 weeks
description: The study aims to evaluate changes in resilience levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Brief Resilience Scale. The scale identifies the individual's ability to bounce back or recover from a stress. This is the key secondary outcome for our study. We assess for change in resilience levels by analyzing the 6-item BRS, which computes a score for each participant by dividing total score obtained/number of questions responded; (range 6-30) and comparing it to pre & post intervention results.
measure: Changes in Covid-19 Prevalence
time frame: Baseline, 6 weeks and 12 weeks
description: The study aims to evaluate changes in Covid-19 prevalence in survey participants and the effect yoga or reading a book has over them. Based on the reported number of cases in the participant cohort we compute Period Prevalence for 3 specified time points. We assess for change in reported prevalence and stratify the results to match with region-wise prevalence.
measure: Changes in self-reported duration of fever and respiratory symptoms in COVID-19 positive participants
time frame: Baseline, 6 weeks and 12 weeks
description: The study aims to evaluate changes in self-reported duration of fever and respiratory symptoms in Covid-19 positive survey participants and the effect yoga or reading a book has over them. Based on the reported number of positive cases in the participant cohort we compare the frequency of duration between the two cohorts i.e. yoga practitioners and control; followed by a comparison between the two control groups viz: yoga group vs idle group.
measure: Changes in self-reported readiness to return to work in COVID-19 positive participants
time frame: Baseline, 6 weeks and 12 weeks
description: The study aims to evaluate changes in self-reported readiness to return to work in Covid-19 positive survey participants and the effect yoga or reading a book has over them. Based on the reported number of positive cases in the participant cohort we compare the frequency of readiness between the two cohorts i.e. yoga practitioners and control; followed by a comparison between the two control groups viz: yoga group vs idle group.
measure: Changes in Mindfulness
time frame: Baseline, 6 weeks and 12 weeks
description: We assessed for change in Mindfulness levels in all participants by using a short form of the validated scale for this purpose namely, Mindfulness Attention Awareness Scale (MAAS). The scale measures the individuals' ability for receptive awareness and attention to present. We compute the MAAS scores for each participant which is a mean score for 5 item questionnaires and compare the pre & post intervention results to look for change.
measure: Changes in Dispositional Positive Emotions Scale (DPES- Joy subscale)
time frame: Baseline, 6 weeks and 12 weeks
description: We assess for change in the individuals' ability to feel joy and look for it in the mundane by using a validated scale for this purpose namely, Dispositional Positive Emotions Scale (DPES) particularly the Joy subscale. The Sub-scale measures the individuals' dispositional ability to feel joy in life. We compute the DPES-JOY subscale scores for each participant which is a mean score for 6 item questionnaires and compare the pre & post intervention results to look for change.
measure: Changes in 4 Item-Patient Health Questionnaire measuring Anxiety and Depression (PHQ-4) levels
time frame: Baseline, 6 weeks and 12 weeks
description: The study aims to evaluate changes in anxiety and depression levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, 4 Item-Patient Health Questionnaire measuring Anxiety and Depression (PHQ-4) Scale. The 4 question scale screens for anxiety and depression in participants by computing sum for the responses (scores range: 0-12) and comparing it to pre & post intervention results.
measure: Changes in well being levels
time frame: Baseline, 6 weeks and 12 weeks
description: The study aims to evaluate changes in wellbeing levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Warwick- Edinburgh Wellbeing Scale (WEMWBS). The scale identifies the individual's aspects of mental health such as: positive affect, satisfying interpersonal relationship and positive functioning. We assess for change in 14 item well-being levels by analyzing the total WEMWBS score for each participant and comparing it to pre & post intervention results.
measure: Changes in Post Traumatic Growth Inventory (PTGI) scores
time frame: Baseline, 6 weeks and 12 weeks
description: The purpose of the growth inventory is to capture the positive outcomes reported by a person who have experienced a traumatic event. This scale collects information from only those participants who identify as being hospitalized during the COVID-19 pandemic and look for their coping ability to the aftermath of the trauma. This 21 item scale is rated on a 6-point Likert response scale. Response from each of the 6 question is then summed to create a total PTGI score.
arm group label: Yoga Practitioners
arm group type: No Intervention
description: Yoga practitioners arm is the observational arm of the study, wherein participants who follow Isha school of yoga and have completed either of the three courses : Inner Engineering Online (IEO), Inner Engineering Completion (Shambhavi Mahamudra kriya) or Shakthi Chalana Kriya can be included in this group. The participant are advised to continue with their routine yoga practice with no change in the duration of practice or frequency of their practices. Participants of this group have expertise in yoga practice and have been practicing yoga for more than 6 weeks before study enrollment.
arm group label: Control Yoga
arm group type: Active Comparator
description: Control Yoga is the active comparator arm of the study. Participants who are randomly allocated to this group, practice "Simha Kriya", a deep breathing exercise taught by the Isha School of yoga.
arm group label: Control Idle
arm group type: Placebo Comparator
description: Control Idle is the active comparator arm of the study. Participants who are randomly allocated to this group, are advised to either read a book for 15 minutes each day or sit idle for 15 minutes. This is the true control group for the study
intervention type: Behavioral
intervention name: Simha Kriya
description: Simha-Kriya involves deep breathing exercises and meditation. It is the practice of extending the breath, expanding our lung capacity and mental concentration and energizing the body. Simha Kriya, when practiced intentionally will unite the mental, physical, and spiritual body through the breath. For the purpose of this study we advocate practice of Simha Kriya at least once a day.
arm group label: Control Yoga
intervention type: Behavioral
intervention name: Reading a Book
description: Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. Reading a book is often inculcated into mindfulness research due to it's impact on the personality and attitude. The simple act of reading a book can have a significant impact on their attitudes and can help them cope better with stress. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely for 15 minutes each day. Reading a book could potentially be substituted with sitting idle for 15 minutes if participants wishes to.
arm group label: Control Idle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Balachundhar Subramaniam, MD, MPH
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Balachundhar Subramaniam
investigator title: PI
mesh term: COVID-19
mesh term: Depression
sharing ipd: No