<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/NCT03268629</url>
  </required_header>
  <id_info>
    <org_study_id>2018-S236</org_study_id>
    <nct_id>NCT03268629</nct_id>
  </id_info>
  <brief_title>'Mindfulness-Based Joyful Sleep' Intervention in Young and Middle-aged Individuals With Insomnia</brief_title>
  <official_title>The Efficacy of a Mindfulness-Based Intervention for Insomnia ('Mindfulness-Based Joyful Sleep') in Young and Middle-aged Individuals With Insomnia in China: Study Protocol of a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central South University</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 primary objective of this proposed three-year (June 01, 2018 to May 31,2020) project is&#xD;
      to verify the effect of 'Mindfulness Based Joyful Sleep' (MBJS) intervention on young and&#xD;
      middle-aged individuals with insomnia in China and preliminarily explore inflammatory&#xD;
      response for the intervention of insomnia applied by it. Previous researches show that&#xD;
      Mindfulness-Based Interventions may relieve insomnia, it is hypothesized that MBJS will be an&#xD;
      effective, feasible and affordable insomnia intervention program in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background：Insomnia is a public health problem attracting extensive attention. Due to the&#xD;
      risks of side effect and drug dependence from the drug treatment of insomnia, the non-drug&#xD;
      treatment has gradually drawn the attention of clinician. In recent years, Mindfulness-Based&#xD;
      Interventions originating from the Eastern culture has created a trend in the application and&#xD;
      research of psychological and physical health fields in western countries, and been found to&#xD;
      be capable of effectively curing or alleviating many psychosomatic diseases and possibly&#xD;
      results in the reversion of gene operation mode and the reduction of inflammation risk.&#xD;
      Researches show that Mindfulness-Based Interventions may relieve insomnia, but existing&#xD;
      research samples and strict randomized controlled trial are insufficient and its application&#xD;
      mechanism is full of uncertainty. In China, empirical research strictly designed is even&#xD;
      scarce in such field. At the earlier stage, investigators have designed a intervention scheme&#xD;
      for insomnia intervention ('Mindfulness-Based Joyful Sleep') with mindfulness-based&#xD;
      meditation and Tai Chi as core technology, and in combination with Chinese culture and have&#xD;
      made preliminary application.&#xD;
&#xD;
      Objectives：This study is expected to verify the effect of 'Mindfulness-Based Joyful Sleep'&#xD;
      program on young and middle-aged patients with insomnia in China and preliminarily explore&#xD;
      the genetic level inflammation mechanism for the intervention of insomnia applied by it.&#xD;
&#xD;
      Methods: Investigators will conduct a 2-arm randomized controlled trial to evaluate the&#xD;
      efficacy of mindfulness-based intervention for insomnia ('Mindfulness-Based Joyful sleep').&#xD;
      Patients with insomnia at the age of 18-59 in China will be recruited for this study.The two&#xD;
      steps to be implemented include: 1) conducting a pilot study to finalize the design of&#xD;
      'Mindfulness-Based Joyful sleep'program and evaluate the feasibility, acceptability and&#xD;
      preliminary outcomes of the'Mindfulness-Based Joyful sleep' program: The final sample is&#xD;
      expected to include18 patients who meet inclusion criteria. Participants will receive 8-week&#xD;
      'Mindfulness-Based Joyful sleep' intervention. The efficacy of 'Mindfulness-Based Joyful&#xD;
      sleep' program will be assessed by PSQI, and feasibility and acceptability of 'Joyful Sleep'&#xD;
      program will be examined by attendance, completion of homework and feedback of participants&#xD;
      on the feeling of the program collected by a focus group. 2) conducting a randomized&#xD;
      controlled trial to evaluate the efficacy of ''Mindfulness-Based Joyful sleep'' program: The&#xD;
      final sample is expected to include 70 patients who meet inclusion criteria. Participants&#xD;
      will be randomly assigned to one of 2 groups, receiving'Mindfulness-Based Joyful&#xD;
      sleep'intervention, or receiving 'Cognitive Behavior Therapy for insomnia (CBT-I)'.&#xD;
      Participants will be assessed at 3 time points by PSG, Sleep Diary, self-reported measures&#xD;
      including PSQI, ISI, CPSS, BDI, STAI and bio-indicator (NF-κB) at baseline, the end of the&#xD;
      Intervention Period, and at a 3-month follow-up.&#xD;
&#xD;
      Implications: This proposed study has important implications in providing valuable insights&#xD;
      into bridging the gap between need and services received for insomnia interventions in China.&#xD;
      If the 'Mindfulness-Based Joyful Sleep' Intervention can be used effectively, it can also be&#xD;
      popularized to many other patients with insomnia in China in future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of sleep quality</measure>
    <time_frame>Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up</time_frame>
    <description>Sleep quality will be measured with Pittsburgh Sleep Quality Index (PSQI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of perceived stress</measure>
    <time_frame>Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up</time_frame>
    <description>Perceived stress will be assessed by Perceived Stress Scale (PSS). The PSS has 14 items. Items are rated on a 5-point Likert-type scale, with higher total scores indicating higher perceived stress (0-13, low perceived stress; 14-26, moderate perceived stress; 27-40, high perceived stress).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of anxiety</measure>
    <time_frame>Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up</time_frame>
    <description>Anxiety will be assessed by State-Trait Anxiety Inventory (STAI). The STAI has 20 items for assessing trait anxiety (TAI) and 20 items for assessing state anxiety (SAI). All items are rated on a 4-point scale, with higher total scores indicate greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of depression</measure>
    <time_frame>Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up</time_frame>
    <description>Depression will be assessed by Beck Depression Inventory (BDI). The BDI consists of 21 items. All items are rated on a 4-point scale, with higher total scores indicating more severe depression (31-40 indicates severe depressive symptoms and scores &gt; 40 indicate extreme depressive symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of nuclear factor-κB (NF-κB)</measure>
    <time_frame>Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up</time_frame>
    <description>NF-κB (nuclear factor-κB) is a collective name for inducible dimeric transcription factors composed of members of the Rel family of DNA-binding proteins that recognize a common sequence motif. NF-κB is found in essentially all cell types and is involved in activation of an exceptionally large number of genes in response to infections, inflammation, and other stressful situations requiring rapid reprogramming of gene expression. NF-κB is clearly one of the most important regulators of proinflammatory gene expression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of sleep quantity</measure>
    <time_frame>Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up</time_frame>
    <description>sleep quantity will be measured with Polysomnography (PSG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of severity of Insomnia Symptoms (ISI)</measure>
    <time_frame>Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up</time_frame>
    <description>Severity of Insomnia Symptoms will be measured with Insomnia Severity Index (ISI). The ISI comprises 7 items, which are each rated on a five-point scale. Total scores range from zero to 28. ISI clinical cut points are categorized as: no insomnia (zero to seven), subthreshold insomnia (eight to 14), moderate insomnia (15-21), and severe insomnia (22-28).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Mindfulness-Based Joyful Sleep</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The proposed 'Joyful Sleep' program will be conducted weekly, 2 hours per session, 8 sessions, group-based in mindfulness. The content and skills are based upon MBSR, MAPs and Tai Chi. The proposed topics include: 1) mindfulness and insomnia, 2) mindful awareness of stress, 3) mindful working with thoughts, 4) mindful working with emotions, 5) mindful interactions, 6) moving mindfulness meditation: the first taste of Tai Chi, 7) moving mindfulness meditation: the second taste of Tai Chi, 8) dealing with obstacles of mindful practices and wrap-up. Mindfulness practices embedded in the program will include mindfulness breathing meditation, body scan meditation, sitting meditation, standing meditation, walking meditation, Taichi, and daily life meditation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBT-I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The CBT-I is a weekly, 2-hour, 8 session, group-based program. CBT-I includes 4 central components: stimulus control, sleep restriction, relaxation training and cognitive therapy. The aim of CBT-I is to reduce sleep-related physiologic and cognitive arousal so that restorative sleep function can be re-established.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-Based Joyful Sleep</intervention_name>
    <description>The proposed &quot;Mindfulness-Based Joyful Sleep&quot; program will be conducted weekly, 2 hours per session, 8 sessions, group-based program in mindfulness.</description>
    <arm_group_label>Mindfulness-Based Joyful Sleep</arm_group_label>
    <other_name>Mindfulness based intervention for insomnia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-I</intervention_name>
    <description>The CBT-I program was delivered to groups of 10-15 individuals over the course of eight, weekly, 2-hour sessions, for a total of 16 contact hours.</description>
    <arm_group_label>CBT-I</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged between 18 and 59 years&#xD;
&#xD;
          2. Diagnosis of insomnia disorder according to the Diagnostic and Statistical Manual of&#xD;
             Mental Disorders, 5th ed (DSM-V)&#xD;
&#xD;
          3. Fully conscious&#xD;
&#xD;
          4. Junior high school or higher education degree&#xD;
&#xD;
          5. No language impairment or communication disorders&#xD;
&#xD;
          6. Willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cognitive impairment&#xD;
&#xD;
          2. Somatic disorders, including but not limited to cardiovascular disease,&#xD;
             cerebrovascular diseases, endocrine diseases, autoimmune diseases, and tumors&#xD;
&#xD;
          3. Mental disorders, including but not limited to schizophrenia, mood disorders, anxiety&#xD;
             disorders, trauma and stress related disorders, substance related disorders&#xD;
&#xD;
          4. Pregnant or lactating women&#xD;
&#xD;
          5. Currently taking any prescribed medication&#xD;
&#xD;
          6. Currently participating in any mindfulness practice for 15 minutes per day (e.g. yoga,&#xD;
             Tai Chi, qigong, meditation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pan Chen, M.D.，Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central South University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pan Chen, M.D.，Ph.D.</last_name>
    <phone>86-13357319516</phone>
    <email>758933968@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Thrid Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>October 5, 2018</last_update_submitted>
  <last_update_submitted_qc>October 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central South University</investigator_affiliation>
    <investigator_full_name>Chen Pan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <keyword>Mindfulness-based Intervention</keyword>
  <keyword>Mindfulness Meditation</keyword>
  <keyword>Tai Chi</keyword>
  <keyword>Inflammation</keyword>
  <keyword>NF-κB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>data of participants' assessment result on PSG, Sleep Diary, PSQI, ISS, CPSS, BDI, STAI, NF-κB during intervention will be shared with other researchers through published articles.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>data will be made available within 6 months of study completion and no time limitation.</ipd_time_frame>
    <ipd_access_criteria>the data will become available on the database which includes the journal publishing the study.</ipd_access_criteria>
  </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/NCT03268629
org study id: 2018-S236
nct id: NCT03268629
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this proposed three-year (June 01, 2018 to May 31,2020) project is
      to verify the effect of 'Mindfulness Based Joyful Sleep' (MBJS) intervention on young and
      middle-aged individuals with insomnia in China and preliminarily explore inflammatory
      response for the intervention of insomnia applied by it. Previous researches show that
      Mindfulness-Based Interventions may relieve insomnia, it is hypothesized that MBJS will be an
      effective, feasible and affordable insomnia intervention program in China.
Background：Insomnia is a public health problem attracting extensive attention. Due to the
      risks of side effect and drug dependence from the drug treatment of insomnia, the non-drug
      treatment has gradually drawn the attention of clinician. In recent years, Mindfulness-Based
      Interventions originating from the Eastern culture has created a trend in the application and
      research of psychological and physical health fields in western countries, and been found to
      be capable of effectively curing or alleviating many psychosomatic diseases and possibly
      results in the reversion of gene operation mode and the reduction of inflammation risk.
      Researches show that Mindfulness-Based Interventions may relieve insomnia, but existing
      research samples and strict randomized controlled trial are insufficient and its application
      mechanism is full of uncertainty. In China, empirical research strictly designed is even
      scarce in such field. At the earlier stage, investigators have designed a intervention scheme
      for insomnia intervention ('Mindfulness-Based Joyful Sleep') with mindfulness-based
      meditation and Tai Chi as core technology, and in combination with Chinese culture and have
      made preliminary application.

      Objectives：This study is expected to verify the effect of 'Mindfulness-Based Joyful Sleep'
      program on young and middle-aged patients with insomnia in China and preliminarily explore
      the genetic level inflammation mechanism for the intervention of insomnia applied by it.

      Methods: Investigators will conduct a 2-arm randomized controlled trial to evaluate the
      efficacy of mindfulness-based intervention for insomnia ('Mindfulness-Based Joyful sleep').
      Patients with insomnia at the age of 18-59 in China will be recruited for this study.The two
      steps to be implemented include: 1) conducting a pilot study to finalize the design of
      'Mindfulness-Based Joyful sleep'program and evaluate the feasibility, acceptability and
      preliminary outcomes of the'Mindfulness-Based Joyful sleep' program: The final sample is
      expected to include18 patients who meet inclusion criteria. Participants will receive 8-week
      'Mindfulness-Based Joyful sleep' intervention. The efficacy of 'Mindfulness-Based Joyful
      sleep' program will be assessed by PSQI, and feasibility and acceptability of 'Joyful Sleep'
      program will be examined by attendance, completion of homework and feedback of participants
      on the feeling of the program collected by a focus group. 2) conducting a randomized
      controlled trial to evaluate the efficacy of ''Mindfulness-Based Joyful sleep'' program: The
      final sample is expected to include 70 patients who meet inclusion criteria. Participants
      will be randomly assigned to one of 2 groups, receiving'Mindfulness-Based Joyful
      sleep'intervention, or receiving 'Cognitive Behavior Therapy for insomnia (CBT-I)'.
      Participants will be assessed at 3 time points by PSG, Sleep Diary, self-reported measures
      including PSQI, ISI, CPSS, BDI, STAI and bio-indicator (NF-κB) at baseline, the end of the
      Intervention Period, and at a 3-month follow-up.

      Implications: This proposed study has important implications in providing valuable insights
      into bridging the gap between need and services received for insomnia interventions in China.
      If the 'Mindfulness-Based Joyful Sleep' Intervention can be used effectively, it can also be
      popularized to many other patients with insomnia in China in future.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change of sleep quality
time frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
description: Sleep quality will be measured with Pittsburgh Sleep Quality Index (PSQI)
measure: change of perceived stress
time frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
description: Perceived stress will be assessed by Perceived Stress Scale (PSS). The PSS has 14 items. Items are rated on a 5-point Likert-type scale, with higher total scores indicating higher perceived stress (0-13, low perceived stress; 14-26, moderate perceived stress; 27-40, high perceived stress).
measure: change of anxiety
time frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
description: Anxiety will be assessed by State-Trait Anxiety Inventory (STAI). The STAI has 20 items for assessing trait anxiety (TAI) and 20 items for assessing state anxiety (SAI). All items are rated on a 4-point scale, with higher total scores indicate greater anxiety.
measure: change of depression
time frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
description: Depression will be assessed by Beck Depression Inventory (BDI). The BDI consists of 21 items. All items are rated on a 4-point scale, with higher total scores indicating more severe depression (31-40 indicates severe depressive symptoms and scores > 40 indicate extreme depressive symptoms).
measure: change of nuclear factor-κB (NF-κB)
time frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
description: NF-κB (nuclear factor-κB) is a collective name for inducible dimeric transcription factors composed of members of the Rel family of DNA-binding proteins that recognize a common sequence motif. NF-κB is found in essentially all cell types and is involved in activation of an exceptionally large number of genes in response to infections, inflammation, and other stressful situations requiring rapid reprogramming of gene expression. NF-κB is clearly one of the most important regulators of proinflammatory gene expression.
measure: change of sleep quantity
time frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
description: sleep quantity will be measured with Polysomnography (PSG).
measure: change of severity of Insomnia Symptoms (ISI)
time frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
description: Severity of Insomnia Symptoms will be measured with Insomnia Severity Index (ISI). The ISI comprises 7 items, which are each rated on a five-point scale. Total scores range from zero to 28. ISI clinical cut points are categorized as: no insomnia (zero to seven), subthreshold insomnia (eight to 14), moderate insomnia (15-21), and severe insomnia (22-28).
arm group label: Mindfulness-Based Joyful Sleep
arm group type: Experimental
description: The proposed 'Joyful Sleep' program will be conducted weekly, 2 hours per session, 8 sessions, group-based in mindfulness. The content and skills are based upon MBSR, MAPs and Tai Chi. The proposed topics include: 1) mindfulness and insomnia, 2) mindful awareness of stress, 3) mindful working with thoughts, 4) mindful working with emotions, 5) mindful interactions, 6) moving mindfulness meditation: the first taste of Tai Chi, 7) moving mindfulness meditation: the second taste of Tai Chi, 8) dealing with obstacles of mindful practices and wrap-up. Mindfulness practices embedded in the program will include mindfulness breathing meditation, body scan meditation, sitting meditation, standing meditation, walking meditation, Taichi, and daily life meditation.
arm group label: CBT-I
arm group type: Active Comparator
description: The CBT-I is a weekly, 2-hour, 8 session, group-based program. CBT-I includes 4 central components: stimulus control, sleep restriction, relaxation training and cognitive therapy. The aim of CBT-I is to reduce sleep-related physiologic and cognitive arousal so that restorative sleep function can be re-established.
intervention type: Behavioral
intervention name: Mindfulness-Based Joyful Sleep
description: The proposed "Mindfulness-Based Joyful Sleep" program will be conducted weekly, 2 hours per session, 8 sessions, group-based program in mindfulness.
arm group label: Mindfulness-Based Joyful Sleep
other name: Mindfulness based intervention for insomnia
intervention type: Behavioral
intervention name: CBT-I
description: The CBT-I program was delivered to groups of 10-15 individuals over the course of eight, weekly, 2-hour sessions, for a total of 16 contact hours.
arm group label: CBT-I
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
last name: Pan Chen, M.D.，Ph.D.
role: Principal Investigator
affiliation: Central South University
last name: Pan Chen, M.D.，Ph.D.
phone: 86-13357319516
email: 758933968@qq.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Central South University
investigator full name: Chen Pan
investigator title: Principal Investigator
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: Yes
ipd description: data of participants' assessment result on PSG, Sleep Diary, PSQI, ISS, CPSS, BDI, STAI, NF-κB during intervention will be shared with other researchers through published articles.
ipd info type: Study Protocol
ipd time frame: data will be made available within 6 months of study completion and no time limitation.
ipd access criteria: the data will become available on the database which includes the journal publishing the study.