<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/NCT04417153</url>
  </required_header>
  <id_info>
    <org_study_id>S-19-176</org_study_id>
    <nct_id>NCT04417153</nct_id>
  </id_info>
  <brief_title>Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes</brief_title>
  <official_title>Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Potential project, www.potentialproject.com</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brahm Centre, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University of Singapore</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>
      Mindfulness training has been gaining popularity in the past decade as a means of improving&#xD;
      general well-being. This trend appears in response to the new stressors that have arisen with&#xD;
      the increased stress of the 21st century. Studies have shown that the psychological state of&#xD;
      metacognitive awareness encapsulated in mindfulness can promote the decreasing of stress as&#xD;
      well as the secondary effect of improving sleep quality; both outcome measures of this study.&#xD;
      While the body of research evaluating these benefits is growing, there is limited emphasis&#xD;
      placed on the individual differences that can affect the overall efficacy of mindfulness&#xD;
      training.&#xD;
&#xD;
      Our aim in this study is to observe the effects of mindfulness training on perceived stress&#xD;
      levels as well as on sleep using subjective measures in a large sample of trainees. To&#xD;
      achieve this, participants will be recruited from a pool of people who have signed up for a&#xD;
      4-week foundational mindfulness or 8-week mindfulness based stress reduction course at Brahm&#xD;
      Centre. Questionnaires will be administered both before and after these courses to evaluate&#xD;
      both stress levels and sleep habits as well as other factors which could contribute to the&#xD;
      efficacy of mindfulness training. These inventories will probe the different facets of&#xD;
      interpersonal differences that could serve to influence the effectiveness of the mindfulness&#xD;
      intervention. In addition, the investigators will also test the effect of conducting the&#xD;
      course online during a situation of emergency, like it is the partial lockdown that was&#xD;
      implemented in Singapore due to the spread of Covid-19.&#xD;
&#xD;
      The proposed study has the potential to provide new insights into the factors that affect the&#xD;
      efficacy of mindfulness on stress and sleep, in a situation of non-emergency (until February&#xD;
      the 6th 2020) as well as during a period of heightened restrictions (DORSCON Orange, from 7th&#xD;
      of February to 6th of April 2020) and a partial lockdown (from 7th of April to 1st of June&#xD;
      2020, or until resume of normal activity). Further, the investigators hope to build an&#xD;
      algorithm that can predict the potential effectiveness of mindfulness on a person by person&#xD;
      basis. This could serve as a foundation for future recommendations for mindfulness training&#xD;
      as well as open the door for future studies that could serve to further customize the&#xD;
      mindfulness training framework to accommodate individual differences&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Health and well-being are increasingly being emphasized in modern society. In response,&#xD;
      mindfulness-based training (MBT) (e.g. Mindfulness Based Stress Reduction (MBSR)&#xD;
      (Kabat-Zinn,1990)) is slowly gaining popularity as a method to alleviate the stress of modern&#xD;
      day living. MBT involves bringing one's attention to the present moment, stopping one's&#xD;
      thoughts from drifting into concerns about the past or the future It has significant effects&#xD;
      on improving mental health via reducing symptoms of stress, anxiety and depression (Fjorback,&#xD;
      Arendt, Ørnbøl, Fink &amp; Walach, 2019). Local studies have similarly demonstrated the efficacy&#xD;
      of mindful training in stress reduction for mental health professionals in Singapore (Suyi,&#xD;
      Meredith &amp; Khan, 2017).&#xD;
&#xD;
      Reducing stress and improving metacognitive processes also contributes to better emotional&#xD;
      regulation, thus facilitating better sleep quality (Chiesa et al., 2011; Zeidan et al.,&#xD;
      2010).. By breaking up cycles of rumination and worry, mindfulness is hypothesized to reduce&#xD;
      &quot;verbal overregulation&quot; and facilitate the disengagement necessary to fall asleep (Gross et&#xD;
      al., 2011). Mindfulness programs have been found to improve sleep quality in both healthy&#xD;
      individuals (Lazar et al., 2000) and patients with medical or psychiatric illness, including&#xD;
      insomnia and depression (Carlson &amp; Garland, 2005; Heidenreich et al., 2006).&#xD;
&#xD;
      While there is much documentation supporting the efficacy of mindfulness training on stress&#xD;
      and sleep, there is little research that attempts to evaluate the interpersonal differences&#xD;
      or factors that predict the efficacy of mindfulness training on sleep and stress. Isolating&#xD;
      these predictive variables consequently allows a better way to evaluate suitability of the&#xD;
      mindfulness intervention on an individual basis; maximizing the results for the individual.&#xD;
      With this new information, individuals suffering from stress and bad sleep would be able to&#xD;
      better be able to select the most effective intervention.&#xD;
&#xD;
      While the concepts above have often been explored in relation to mindfulness, no studies to&#xD;
      date have used machine learning to assess how these variables predispose an individual to&#xD;
      benefit from mindfulness training. Generating this algorithm will allow for the prediction of&#xD;
      treatment response in future trainees. Further, a better understanding of the effect of&#xD;
      individual differences on efficacy can open the door for future research to examine how and&#xD;
      why these differing results exist and incorporate this information to increase the&#xD;
      effectiveness of mindfulness training.&#xD;
&#xD;
      Participants signing up for the 4 or 8 weeks mindfulness training courses at the Brahm Centre&#xD;
      and run by Potential Project (two external organization providing Mindfulness based courses)&#xD;
      will be automatically sent a link to the questionnaire packet several days after course&#xD;
      enrolment. Participants will be provided with a survey link in the enrolment email that is&#xD;
      sent to participants to confirm their enrolment, separate recruitment e-mails will not be&#xD;
      sent out.&#xD;
&#xD;
      Participants will be informed that the data will form part of a research study, that any&#xD;
      information provided is anonymous, and that they can opt out of completing the questionnaires&#xD;
      without any penalty to their class enrolment. Recruitment emails will not be sent out. On&#xD;
      enrollment in any of the courses, participants will be informed that there is an option to&#xD;
      take part in the study.&#xD;
&#xD;
      Staff sending out emails will be separate from staff carrying out the mindfulness training&#xD;
      programs. This will ensure that there will be no scenario where a dependent relationship will&#xD;
      occur.&#xD;
&#xD;
      Participants can decide if they prefer to sign up for the 4 weeks or 8 weeks Mindfulness&#xD;
      courses, depending on availability at the Mindfulness centres.&#xD;
&#xD;
      Questionnaires will be administered through the platform SurveyMonkey ©. SSL encryption will&#xD;
      be used to protect sensitive data as it is relayed between the respondent's computer and&#xD;
      SurveyMonkey© servers.&#xD;
&#xD;
      Questionnaires will be administered twice, with the predictor surveys administered at&#xD;
      pre-intervention only, and outcome variables collected both pre- and post-intervention (PSQI&#xD;
      and PSAS).&#xD;
&#xD;
      Predictive factors 10 predictive factors were chosen to evaluate their predictive qualities&#xD;
      on the effectiveness of mindfulness training in reducing stress and improving sleep:&#xD;
      Personality: Mindfulness training has been shown to be more effective in students with higher&#xD;
      scores in conscientiousness and neuroticism (Winning &amp; Boag, 2015). As such, the NEO-FFI-3&#xD;
      will be used to measure the dimensions of personality.&#xD;
&#xD;
      Trait Mindfulness: Baseline trait mindfulness has been shown to be a significant moderator of&#xD;
      MBSR intervention effects (Shapiro, Brown, Thoresen, &amp; Plante, 2010). The investigators have&#xD;
      included trait mindfulness to corroborate previous studies that have shown this relationship&#xD;
      as well as to explore its effect within a local population.&#xD;
&#xD;
      Mood and depression: While depression and mood has been often measured in conjunction with&#xD;
      Mindfulness training, there has been little to no research on how it relates to mindfulness&#xD;
      training efficacy State-Trait Anxiety: Mindfulness has been shown to alleviate state trait&#xD;
      anxiety in individuals (Bergen-Cico &amp; Cheon, 2013). The investigators are thus interested in&#xD;
      whether a higher or lower baseline score in the STAI will affect the efficacy of mindfulness&#xD;
      training Empathy: There are mixed results in regards to the relationship between empathy and&#xD;
      mindfulness; with some studies finding no significant connection (Bergen-Cico &amp; Cheon, 2013),&#xD;
      and others showing differing effectiveness dependent on personality traits (Winning &amp; Boag,&#xD;
      2015; Ridderinkhof, de Bruin, Brummelman, &amp; Bögels, 2017).&#xD;
&#xD;
      Self-compassion: Self compassion is believed to be developed and enhanced through mindfulness&#xD;
      training. Birnie, Speca &amp; Carlson (2010) found strong associations between self-compassion&#xD;
      and mindfulness. It was found that changes in self-compassion were predictive of changes in&#xD;
      mindfulness.&#xD;
&#xD;
      Learning styles: This was included to investigate whether the difference in learning styles&#xD;
      in individuals would affect the ways in which the mindfulness training are internalized; in&#xD;
      turn influencing the efficacy of mindfulness training.&#xD;
&#xD;
      Expectancy/Credibility: Expectancy has been shown to be predictive in evaluating the outcome&#xD;
      on some measures (Devilly &amp; Borkovec, 2000). It would be beneficial to understand its effect&#xD;
      on the effectiveness of mindfulness training.&#xD;
&#xD;
      Emotional Regulation: Emotion regulation has been shown to improve with mindfulness-based&#xD;
      interventions (Guendelman, Medeiros &amp; Rampes, 2017). The investigators are interested in&#xD;
      understanding the effect of emotional regulation on mindfulness training.&#xD;
&#xD;
      Coping Methods: Mindfulness has been shown to affect the coping strategies used in&#xD;
      individuals. The effect of coping methods on mindfulness training efficacy is thus of&#xD;
      interest to our study.&#xD;
&#xD;
      Questionnaires Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)&#xD;
&#xD;
      Perceived Stress Scale (PSS; Cohen, Kamarck &amp; Mermelstein,1983)&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      This research has four objectives:&#xD;
&#xD;
      To corroborate findings on the effect of mindfulness training on perceived stress.&#xD;
&#xD;
      Hypothesis: based on previous literature, the investigators predict that mindfulness&#xD;
      interventions will decrease perceived stress, with lower PSS score post intervention.&#xD;
&#xD;
      To test whether individual differences might be predictive of the effectiveness of&#xD;
      mindfulness training on stress Hypothesis: through the use of machine learning, the&#xD;
      investigators aim to create a model that can predict changes in perceived Stress (PSS) post&#xD;
      intervention based on individual predictors as defined above.&#xD;
&#xD;
      To test whether individual differences might be predictive of the effectiveness of&#xD;
      mindfulness training on sleep Hypothesis: through the use of machine learning, the&#xD;
      investigators aim to create a model that can predict changes in Sleep quality (PSQI) post&#xD;
      intervention based on individual predictors as defined above.&#xD;
&#xD;
      To test the effects of group mindfulness interventions on stress and sleep quality during a&#xD;
      period of global uncertainty, a partial lockdown due to the COVID-19 pandemic, compared to&#xD;
      Mindfulness intervention in a non-emergency situation.&#xD;
&#xD;
      Hypothesis (i):the investigator predict that participants would report higher levels of&#xD;
      perceived stress and poorer sleep quality at baseline during the period of the pandemic&#xD;
      (DORSCON Orange and lockdown) relative to an earlier control period; Hypothesis (ii): the&#xD;
      investigators predict that online mindfulness training (during lockdown) would have be&#xD;
      non-inferior/equivalent in reducing perceived stress and improving sleep quality compared&#xD;
      with DORSCON Orange and the control period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index total Score</measure>
    <time_frame>Up to one month</time_frame>
    <description>Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score above 5 suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep quality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in subjective measures of Stress: Perceived Stress Scale (PSS)</measure>
    <time_frame>Up to one month</time_frame>
    <description>The PSS measures whether different aspects of life were perceived as stressful by participants on a 5-point scale (where 0 was never and 4 was very often) in the past month. Positively worded questions are reversed scored and all 10 questions ratings are summarised into a total score, which ranges from 0 to 40, with higher scores indicating more perceived stress.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Time in Bed (TIB)</measure>
    <time_frame>Up to one month</time_frame>
    <description>Measured within the Pittsburgh Sleep Quality Index questionnaire. This is the total perceived time in bed in minutes, calculated as item 3 of the PSQI (&quot;When have you usually gotten up in the morning?&quot;) minus item 1 (&quot;When have you usually gone to bed?&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Total Sleep Time (TST)</measure>
    <time_frame>Up to one month</time_frame>
    <description>Measured within the Pittsburgh Sleep Quality Index questionnaire. Total sleep time reflects the amount of time in minutes participants were effectively sleeping while in bed, without periods of wakefulness, on average over the past month. This will be measured by item 4 of the PSQI questionnaires: &quot;How many hours of actual sleep do you get at night?&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Sleep Onset Latency (SOL)</measure>
    <time_frame>Up to one month</time_frame>
    <description>Measured within the Pittsburgh Sleep Quality Index. This is the perceived time, in minutes, that takes participants to fall asleep from the moment they go to bed. This corresponds to item 2 of the PSQI: &quot;How long (in minutes) has it taken you to fall asleep each night?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective Wake After Sleep Onset (WASO)</measure>
    <time_frame>Up to one month</time_frame>
    <description>Measured within the Pittsburgh Sleep Quality Index questionnaire. In addition to Sleep Onset Latency (Secondary outcome 1), a second subjective measure of sleep quality is extracted from the PSQI: time of perceived wakefulness occurring after defined sleep onset. WASO is calculated by taking into account the total time spent in bed (TST) minus total sleep time (TST) and minus sleep onset latency (SOL), in minutes. High WASO scores reflect low sleep continuity and poor sleep quality.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <arm_group>
    <arm_group_label>Mindfulness based intervention, Non Emergency (MBI-NE)</arm_group_label>
    <description>4 week Mindfulness foundation course face to face (MF-NE) or&#xD;
8 week Mindfulness Based stress reduction face to face (MBSR-NE)&#xD;
The mindfulness-based intervention consists of either four (MF) or eight (MBSR) 2-hour sessions. Participants will be provided handouts for the information covered during these talks and discussions.&#xD;
Classes are done at the Mindfulness centres providing the courses, with face to face sessions with the teacher and up to 30 participants together</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness based intervention, DORSCON Orange (MBI-Orange))</arm_group_label>
    <description>4 week Mindfulness foundation course face to face (MF-Orange) or&#xD;
8 week Mindfulness Based stress reduction face to face (MBSR-Orange)&#xD;
The content of these courses are the same as in the non emergency ones, and consist of four (MF) or eight (MBSR) 2-hour sessions covering various mindfulness techniques. Participants will also be provided with the same handouts for the information covered during these talks and discussions.&#xD;
Classes are done at the Mindfulness centres providing the courses, with face to face sessions with the teacher and up to 30 participants together.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness based intervention, Partial lockdown (MBI-Covid)</arm_group_label>
    <description>4 week Mindfulness foundation course online (MF-Covid) or&#xD;
8 week Mindfulness Based stress reduction online, partial lockdown situation (MBSR-Covid)&#xD;
The content of these courses are the same as in the non emergency ones. Participants will also be provided with the same handouts for the information covered during these talks and discussions.&#xD;
During the partial lockdown, classes can only be held online, using platform as zoom with the teacher and up to around 17 participants together.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Based Intervention</intervention_name>
    <description>The mindfulness-based intervention consists of either four (MF) or eight (MBSR) 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion). Participants will be provided handouts for the information covered during these talks and discussions.These can be done either face to face or online.</description>
    <arm_group_label>Mindfulness based intervention, DORSCON Orange (MBI-Orange))</arm_group_label>
    <arm_group_label>Mindfulness based intervention, Non Emergency (MBI-NE)</arm_group_label>
    <arm_group_label>Mindfulness based intervention, Partial lockdown (MBI-Covid)</arm_group_label>
    <other_name>MBI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any individual above 21 years old enrolled in Mindfulness-Based Stress&#xD;
        Reduction/Mindfulness Foundation course at Brahm Centre or with a mindfulness course with&#xD;
        Potential Project Singapore that is also interested in participating in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any individual above 21 years old enrolled in Mindfulness-Based Stress&#xD;
             Reduction/Mindfulness Foundation course at Brahm Centre or with a mindfulness course&#xD;
             with Potential Project can be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julian Lim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Singapore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julian Lim, PhD</last_name>
    <phone>+6565165438</phone>
    <email>julian.lim@nus.edu.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francesca Perini, PhD</last_name>
    <phone>+6565165438</phone>
    <email>francesca@nus.edu.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National University Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>119077</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julian Lim, PhD</last_name>
      <phone>+6565165438</phone>
      <email>julian.lim@nus.edu.sg</email>
    </contact>
    <contact_backup>
      <last_name>Francesca Perini, PhD</last_name>
      <phone>+6565165438</phone>
      <email>francesca@nude.edu.sg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.</citation>
    <PMID>2748771</PMID>
  </reference>
  <reference>
    <citation>Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology. 2004 May;29(4):448-74. doi: 10.1016/s0306-4530(03)00054-4.</citation>
    <PMID>14749092</PMID>
  </reference>
  <reference>
    <citation>Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.</citation>
    <PMID>11132119</PMID>
  </reference>
  <reference>
    <citation>Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.</citation>
    <PMID>21534932</PMID>
  </reference>
  <reference>
    <citation>Heidenreich T, Tuin I, Pflug B, Michal M, Michalak J. Mindfulness-based cognitive therapy for persistent insomnia: a pilot study. Psychother Psychosom. 2006;75(3):188-9. doi: 10.1159/000091778. No abstract available.</citation>
    <PMID>16636636</PMID>
  </reference>
  <reference>
    <citation>Kabat-Zinn, J. (1990) Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacourt.</citation>
  </reference>
  <reference>
    <citation>Birnie, K., Speca, M., &amp; Carlson, L. (2010). Exploring self-compassion and empathy in the context of mindfulness-based stress reduction (MBSR). Stress And Health, 26(5), 359-371. doi: 10.1002/smi.1305</citation>
  </reference>
  <reference>
    <citation>Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.</citation>
    <PMID>6668417</PMID>
  </reference>
  <reference>
    <citation>Suyi Y, Meredith P, Khan A. Effectiveness of Mindfulness Intervention in Reducing Stress and Burnout for Mental Health Professionals in Singapore. Explore (NY). 2017 Sep-Oct;13(5):319-326. doi: 10.1016/j.explore.2017.06.001. Epub 2017 Jul 1.</citation>
    <PMID>28780213</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Singapore</investigator_affiliation>
    <investigator_full_name>Julian Lim</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>Covid</keyword>
  <keyword>lockdown</keyword>
  <keyword>Stress</keyword>
  <keyword>Sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04417153
org study id: S-19-176
nct id: NCT04417153
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mindfulness training has been gaining popularity in the past decade as a means of improving
      general well-being. This trend appears in response to the new stressors that have arisen with
      the increased stress of the 21st century. Studies have shown that the psychological state of
      metacognitive awareness encapsulated in mindfulness can promote the decreasing of stress as
      well as the secondary effect of improving sleep quality; both outcome measures of this study.
      While the body of research evaluating these benefits is growing, there is limited emphasis
      placed on the individual differences that can affect the overall efficacy of mindfulness
      training.

      Our aim in this study is to observe the effects of mindfulness training on perceived stress
      levels as well as on sleep using subjective measures in a large sample of trainees. To
      achieve this, participants will be recruited from a pool of people who have signed up for a
      4-week foundational mindfulness or 8-week mindfulness based stress reduction course at Brahm
      Centre. Questionnaires will be administered both before and after these courses to evaluate
      both stress levels and sleep habits as well as other factors which could contribute to the
      efficacy of mindfulness training. These inventories will probe the different facets of
      interpersonal differences that could serve to influence the effectiveness of the mindfulness
      intervention. In addition, the investigators will also test the effect of conducting the
      course online during a situation of emergency, like it is the partial lockdown that was
      implemented in Singapore due to the spread of Covid-19.

      The proposed study has the potential to provide new insights into the factors that affect the
      efficacy of mindfulness on stress and sleep, in a situation of non-emergency (until February
      the 6th 2020) as well as during a period of heightened restrictions (DORSCON Orange, from 7th
      of February to 6th of April 2020) and a partial lockdown (from 7th of April to 1st of June
      2020, or until resume of normal activity). Further, the investigators hope to build an
      algorithm that can predict the potential effectiveness of mindfulness on a person by person
      basis. This could serve as a foundation for future recommendations for mindfulness training
      as well as open the door for future studies that could serve to further customize the
      mindfulness training framework to accommodate individual differences
Health and well-being are increasingly being emphasized in modern society. In response,
      mindfulness-based training (MBT) (e.g. Mindfulness Based Stress Reduction (MBSR)
      (Kabat-Zinn,1990)) is slowly gaining popularity as a method to alleviate the stress of modern
      day living. MBT involves bringing one's attention to the present moment, stopping one's
      thoughts from drifting into concerns about the past or the future It has significant effects
      on improving mental health via reducing symptoms of stress, anxiety and depression (Fjorback,
      Arendt, Ørnbøl, Fink & Walach, 2019). Local studies have similarly demonstrated the efficacy
      of mindful training in stress reduction for mental health professionals in Singapore (Suyi,
      Meredith & Khan, 2017).

      Reducing stress and improving metacognitive processes also contributes to better emotional
      regulation, thus facilitating better sleep quality (Chiesa et al., 2011; Zeidan et al.,
      2010).. By breaking up cycles of rumination and worry, mindfulness is hypothesized to reduce
      "verbal overregulation" and facilitate the disengagement necessary to fall asleep (Gross et
      al., 2011). Mindfulness programs have been found to improve sleep quality in both healthy
      individuals (Lazar et al., 2000) and patients with medical or psychiatric illness, including
      insomnia and depression (Carlson & Garland, 2005; Heidenreich et al., 2006).

      While there is much documentation supporting the efficacy of mindfulness training on stress
      and sleep, there is little research that attempts to evaluate the interpersonal differences
      or factors that predict the efficacy of mindfulness training on sleep and stress. Isolating
      these predictive variables consequently allows a better way to evaluate suitability of the
      mindfulness intervention on an individual basis; maximizing the results for the individual.
      With this new information, individuals suffering from stress and bad sleep would be able to
      better be able to select the most effective intervention.

      While the concepts above have often been explored in relation to mindfulness, no studies to
      date have used machine learning to assess how these variables predispose an individual to
      benefit from mindfulness training. Generating this algorithm will allow for the prediction of
      treatment response in future trainees. Further, a better understanding of the effect of
      individual differences on efficacy can open the door for future research to examine how and
      why these differing results exist and incorporate this information to increase the
      effectiveness of mindfulness training.

      Participants signing up for the 4 or 8 weeks mindfulness training courses at the Brahm Centre
      and run by Potential Project (two external organization providing Mindfulness based courses)
      will be automatically sent a link to the questionnaire packet several days after course
      enrolment. Participants will be provided with a survey link in the enrolment email that is
      sent to participants to confirm their enrolment, separate recruitment e-mails will not be
      sent out.

      Participants will be informed that the data will form part of a research study, that any
      information provided is anonymous, and that they can opt out of completing the questionnaires
      without any penalty to their class enrolment. Recruitment emails will not be sent out. On
      enrollment in any of the courses, participants will be informed that there is an option to
      take part in the study.

      Staff sending out emails will be separate from staff carrying out the mindfulness training
      programs. This will ensure that there will be no scenario where a dependent relationship will
      occur.

      Participants can decide if they prefer to sign up for the 4 weeks or 8 weeks Mindfulness
      courses, depending on availability at the Mindfulness centres.

      Questionnaires will be administered through the platform SurveyMonkey ©. SSL encryption will
      be used to protect sensitive data as it is relayed between the respondent's computer and
      SurveyMonkey© servers.

      Questionnaires will be administered twice, with the predictor surveys administered at
      pre-intervention only, and outcome variables collected both pre- and post-intervention (PSQI
      and PSAS).

      Predictive factors 10 predictive factors were chosen to evaluate their predictive qualities
      on the effectiveness of mindfulness training in reducing stress and improving sleep:
      Personality: Mindfulness training has been shown to be more effective in students with higher
      scores in conscientiousness and neuroticism (Winning & Boag, 2015). As such, the NEO-FFI-3
      will be used to measure the dimensions of personality.

      Trait Mindfulness: Baseline trait mindfulness has been shown to be a significant moderator of
      MBSR intervention effects (Shapiro, Brown, Thoresen, & Plante, 2010). The investigators have
      included trait mindfulness to corroborate previous studies that have shown this relationship
      as well as to explore its effect within a local population.

      Mood and depression: While depression and mood has been often measured in conjunction with
      Mindfulness training, there has been little to no research on how it relates to mindfulness
      training efficacy State-Trait Anxiety: Mindfulness has been shown to alleviate state trait
      anxiety in individuals (Bergen-Cico & Cheon, 2013). The investigators are thus interested in
      whether a higher or lower baseline score in the STAI will affect the efficacy of mindfulness
      training Empathy: There are mixed results in regards to the relationship between empathy and
      mindfulness; with some studies finding no significant connection (Bergen-Cico & Cheon, 2013),
      and others showing differing effectiveness dependent on personality traits (Winning & Boag,
      2015; Ridderinkhof, de Bruin, Brummelman, & Bögels, 2017).

      Self-compassion: Self compassion is believed to be developed and enhanced through mindfulness
      training. Birnie, Speca & Carlson (2010) found strong associations between self-compassion
      and mindfulness. It was found that changes in self-compassion were predictive of changes in
      mindfulness.

      Learning styles: This was included to investigate whether the difference in learning styles
      in individuals would affect the ways in which the mindfulness training are internalized; in
      turn influencing the efficacy of mindfulness training.

      Expectancy/Credibility: Expectancy has been shown to be predictive in evaluating the outcome
      on some measures (Devilly & Borkovec, 2000). It would be beneficial to understand its effect
      on the effectiveness of mindfulness training.

      Emotional Regulation: Emotion regulation has been shown to improve with mindfulness-based
      interventions (Guendelman, Medeiros & Rampes, 2017). The investigators are interested in
      understanding the effect of emotional regulation on mindfulness training.

      Coping Methods: Mindfulness has been shown to affect the coping strategies used in
      individuals. The effect of coping methods on mindfulness training efficacy is thus of
      interest to our study.

      Questionnaires Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)

      Perceived Stress Scale (PSS; Cohen, Kamarck & Mermelstein,1983)

      Objectives

      This research has four objectives:

      To corroborate findings on the effect of mindfulness training on perceived stress.

      Hypothesis: based on previous literature, the investigators predict that mindfulness
      interventions will decrease perceived stress, with lower PSS score post intervention.

      To test whether individual differences might be predictive of the effectiveness of
      mindfulness training on stress Hypothesis: through the use of machine learning, the
      investigators aim to create a model that can predict changes in perceived Stress (PSS) post
      intervention based on individual predictors as defined above.

      To test whether individual differences might be predictive of the effectiveness of
      mindfulness training on sleep Hypothesis: through the use of machine learning, the
      investigators aim to create a model that can predict changes in Sleep quality (PSQI) post
      intervention based on individual predictors as defined above.

      To test the effects of group mindfulness interventions on stress and sleep quality during a
      period of global uncertainty, a partial lockdown due to the COVID-19 pandemic, compared to
      Mindfulness intervention in a non-emergency situation.

      Hypothesis (i):the investigator predict that participants would report higher levels of
      perceived stress and poorer sleep quality at baseline during the period of the pandemic
      (DORSCON Orange and lockdown) relative to an earlier control period; Hypothesis (ii): the
      investigators predict that online mindfulness training (during lockdown) would have be
      non-inferior/equivalent in reducing perceived stress and improving sleep quality compared
      with DORSCON Orange and the control period.
observational model: Cohort
time perspective: Prospective
measure: Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index total Score
time frame: Up to one month
description: Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score above 5 suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep quality
measure: Change in subjective measures of Stress: Perceived Stress Scale (PSS)
time frame: Up to one month
description: The PSS measures whether different aspects of life were perceived as stressful by participants on a 5-point scale (where 0 was never and 4 was very often) in the past month. Positively worded questions are reversed scored and all 10 questions ratings are summarised into a total score, which ranges from 0 to 40, with higher scores indicating more perceived stress.
measure: Change in Subjective Time in Bed (TIB)
time frame: Up to one month
description: Measured within the Pittsburgh Sleep Quality Index questionnaire. This is the total perceived time in bed in minutes, calculated as item 3 of the PSQI ("When have you usually gotten up in the morning?") minus item 1 ("When have you usually gone to bed?")
measure: Change in Subjective Total Sleep Time (TST)
time frame: Up to one month
description: Measured within the Pittsburgh Sleep Quality Index questionnaire. Total sleep time reflects the amount of time in minutes participants were effectively sleeping while in bed, without periods of wakefulness, on average over the past month. This will be measured by item 4 of the PSQI questionnaires: "How many hours of actual sleep do you get at night?".
measure: Change in Subjective Sleep Onset Latency (SOL)
time frame: Up to one month
description: Measured within the Pittsburgh Sleep Quality Index. This is the perceived time, in minutes, that takes participants to fall asleep from the moment they go to bed. This corresponds to item 2 of the PSQI: "How long (in minutes) has it taken you to fall asleep each night?"
measure: Change in Subjective Wake After Sleep Onset (WASO)
time frame: Up to one month
description: Measured within the Pittsburgh Sleep Quality Index questionnaire. In addition to Sleep Onset Latency (Secondary outcome 1), a second subjective measure of sleep quality is extracted from the PSQI: time of perceived wakefulness occurring after defined sleep onset. WASO is calculated by taking into account the total time spent in bed (TST) minus total sleep time (TST) and minus sleep onset latency (SOL), in minutes. High WASO scores reflect low sleep continuity and poor sleep quality.
arm group label: Mindfulness based intervention, Non Emergency (MBI-NE)
description: 4 week Mindfulness foundation course face to face (MF-NE) or
8 week Mindfulness Based stress reduction face to face (MBSR-NE)
The mindfulness-based intervention consists of either four (MF) or eight (MBSR) 2-hour sessions. Participants will be provided handouts for the information covered during these talks and discussions.
Classes are done at the Mindfulness centres providing the courses, with face to face sessions with the teacher and up to 30 participants together
arm group label: Mindfulness based intervention, DORSCON Orange (MBI-Orange))
description: 4 week Mindfulness foundation course face to face (MF-Orange) or
8 week Mindfulness Based stress reduction face to face (MBSR-Orange)
The content of these courses are the same as in the non emergency ones, and consist of four (MF) or eight (MBSR) 2-hour sessions covering various mindfulness techniques. Participants will also be provided with the same handouts for the information covered during these talks and discussions.
Classes are done at the Mindfulness centres providing the courses, with face to face sessions with the teacher and up to 30 participants together.
arm group label: Mindfulness based intervention, Partial lockdown (MBI-Covid)
description: 4 week Mindfulness foundation course online (MF-Covid) or
8 week Mindfulness Based stress reduction online, partial lockdown situation (MBSR-Covid)
The content of these courses are the same as in the non emergency ones. Participants will also be provided with the same handouts for the information covered during these talks and discussions.
During the partial lockdown, classes can only be held online, using platform as zoom with the teacher and up to around 17 participants together.
intervention type: Behavioral
intervention name: Mindfulness Based Intervention
description: The mindfulness-based intervention consists of either four (MF) or eight (MBSR) 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion). Participants will be provided handouts for the information covered during these talks and discussions.These can be done either face to face or online.
arm group label: Mindfulness based intervention, DORSCON Orange (MBI-Orange))
arm group label: Mindfulness based intervention, Non Emergency (MBI-NE)
arm group label: Mindfulness based intervention, Partial lockdown (MBI-Covid)
other name: MBI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Julian Lim, PhD
role: Principal Investigator
affiliation: National University of Singapore
last name: Julian Lim, PhD
phone: +6565165438
email: julian.lim@nus.edu.sg
last name: Francesca Perini, PhD
phone: +6565165438
email: francesca@nus.edu.sg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Singapore
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PMID: 2748771
citation: Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology. 2004 May;29(4):448-74. doi: 10.1016/s0306-4530(03)00054-4.
PMID: 14749092
citation: Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PMID: 11132119
citation: Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.
PMID: 21534932
citation: Heidenreich T, Tuin I, Pflug B, Michal M, Michalak J. Mindfulness-based cognitive therapy for persistent insomnia: a pilot study. Psychother Psychosom. 2006;75(3):188-9. doi: 10.1159/000091778. No abstract available.
PMID: 16636636
citation: Kabat-Zinn, J. (1990) Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacourt.
citation: Birnie, K., Speca, M., & Carlson, L. (2010). Exploring self-compassion and empathy in the context of mindfulness-based stress reduction (MBSR). Stress And Health, 26(5), 359-371. doi: 10.1002/smi.1305
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PMID: 6668417
citation: Suyi Y, Meredith P, Khan A. Effectiveness of Mindfulness Intervention in Reducing Stress and Burnout for Mental Health Professionals in Singapore. Explore (NY). 2017 Sep-Oct;13(5):319-326. doi: 10.1016/j.explore.2017.06.001. Epub 2017 Jul 1.
PMID: 28780213
responsible party type: Principal Investigator
investigator affiliation: National University of Singapore
investigator full name: Julian Lim
investigator title: Assistant Professor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Stress, Psychological
sharing ipd: Undecided