<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/NCT04503343</url>
  </required_header>
  <id_info>
    <org_study_id>MD201908</org_study_id>
    <nct_id>NCT04503343</nct_id>
  </id_info>
  <brief_title>Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression</brief_title>
  <official_title>Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression</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>
    <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, relaxation training, and cerebellar electrical stimulation were used to&#xD;
      intervene in the cognitive function of healthy individuals and individuals with first episode&#xD;
      depression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this proposed study,the investigators will evaluate the effects of different&#xD;
      non-pharmacological interventions (physical/psychological) on emotion-related cognitive&#xD;
      function.This project will use a variety of intervention methods to conduct research in&#xD;
      healthy individuals and patients with mood disorders. The main intervention methods include:&#xD;
      (1) mindfulness training;(2) relaxation training;(3) cerebellar electrical stimulation.&#xD;
&#xD;
      The study will recruit 80 healthy subjects and 40 first-episode depression patients. The&#xD;
      study consisted of three steps: First, subjects filled in personal data and completed the&#xD;
      first screening, randomly assigned groups, and filled in the pre-intervention&#xD;
      questionnaire;Second, give a one-time non-drug intervention (mindfulness training, relaxation&#xD;
      training or cerebellar electrical stimulation);Step 3: After the intervention, the subjects&#xD;
      filled in the post-intervention questionnaire and completed the cognitive task test.Clinical&#xD;
      efficacy and safety assessment will be done at first time. The specific aims are to evaluate&#xD;
      the effect of non-drug therapy on cognitive function in healthy individuals and patients with&#xD;
      first episode depression. and the behavior was evaluated by cognitive function task.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>The change of mindfulness training on cognitive function in healthy individuals</measure>
    <time_frame>baseline</time_frame>
    <description>Cognitive function are measured by Faces Emotion Recognition Task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of mindfulness training on cognitive function in patients with first episode depression</measure>
    <time_frame>baseline</time_frame>
    <description>Cognitive function are measured by Emotional Categorisation Task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of cerebellar electrical stimulation on cognitive function in healthy individuals</measure>
    <time_frame>baseline</time_frame>
    <description>Cognitive function are measured by Emotional Recall Task</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>subjects are randomly divided into the intervention group. and they will be given a one-time non-drug intervention(mindfulness training, relaxation training or electrical cerebellar stimulation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>subjects are randomly divided into the control group and regularly followed up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-drug intervention</intervention_name>
    <description>mindfulness training, relaxation training, or electrical cerebellar stimulation</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Healthy individuals group:&#xD;
&#xD;
          1. Aged between 16 and 34;&#xD;
&#xD;
          2. Does not meet the criteria of the DIAGNOSTIC and Statistical Manual of Mental&#xD;
             Disorders, DSM-5,Does not meet the diagnosis of depression, bipolar disorder and other&#xD;
             mental disorders.&#xD;
&#xD;
        First episode depression group:&#xD;
&#xD;
          1. Aged between 16 and 34;&#xD;
&#xD;
          2. Clinically diagnosed as having depression according to the DIAGNOSTIC and Statistical&#xD;
             Manual of Mental Disorders (DSM-5);&#xD;
&#xD;
          3. First attack, not taking medicine, no risk of serious suicide NSSI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. There are serious physical diseases, such as epilepsy, brain trauma, intracranial&#xD;
             space-occupying lesions, severe audiovisual disorders, congenital heart disease, etc.;&#xD;
&#xD;
          2. Both Hamilton Depression Scale and Beck Depression Self-Rating Scale indicate severe&#xD;
             depression or severe mental illness;&#xD;
&#xD;
          3. Affected by mental illness, it is difficult to conduct smooth and effective verbal&#xD;
             communication and psychological measurement operation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>34 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianjun Ou, doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Central South University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Runsen Chen, doctor</last_name>
    <role>Study Director</role>
    <affiliation>Central South University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central South University</investigator_affiliation>
    <investigator_full_name>Jian-Jun Ou</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT04503343
org study id: MD201908
nct id: NCT04503343
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Mindfulness training, relaxation training, and cerebellar electrical stimulation were used to
      intervene in the cognitive function of healthy individuals and individuals with first episode
      depression
In this proposed study,the investigators will evaluate the effects of different
      non-pharmacological interventions (physical/psychological) on emotion-related cognitive
      function.This project will use a variety of intervention methods to conduct research in
      healthy individuals and patients with mood disorders. The main intervention methods include:
      (1) mindfulness training;(2) relaxation training;(3) cerebellar electrical stimulation.

      The study will recruit 80 healthy subjects and 40 first-episode depression patients. The
      study consisted of three steps: First, subjects filled in personal data and completed the
      first screening, randomly assigned groups, and filled in the pre-intervention
      questionnaire;Second, give a one-time non-drug intervention (mindfulness training, relaxation
      training or cerebellar electrical stimulation);Step 3: After the intervention, the subjects
      filled in the post-intervention questionnaire and completed the cognitive task test.Clinical
      efficacy and safety assessment will be done at first time. The specific aims are to evaluate
      the effect of non-drug therapy on cognitive function in healthy individuals and patients with
      first episode depression. and the behavior was evaluated by cognitive function task.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change of mindfulness training on cognitive function in healthy individuals
time frame: baseline
description: Cognitive function are measured by Faces Emotion Recognition Task
measure: The change of mindfulness training on cognitive function in patients with first episode depression
time frame: baseline
description: Cognitive function are measured by Emotional Categorisation Task
measure: The change of cerebellar electrical stimulation on cognitive function in healthy individuals
time frame: baseline
description: Cognitive function are measured by Emotional Recall Task
arm group label: intervention group
arm group type: Other
description: subjects are randomly divided into the intervention group. and they will be given a one-time non-drug intervention(mindfulness training, relaxation training or electrical cerebellar stimulation).
arm group label: control group
arm group type: No Intervention
description: subjects are randomly divided into the control group and regularly followed up.
intervention type: Other
intervention name: non-drug intervention
description: mindfulness training, relaxation training, or electrical cerebellar stimulation
arm group label: intervention group
criteria: 
gender: All
minimum age: 16 Years
maximum age: 34 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jianjun Ou, doctor
role: Study Chair
affiliation: Central South University
last name: Runsen Chen, doctor
role: Study Director
affiliation: Central South University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Central South University
investigator full name: Jian-Jun Ou
investigator title: Principal Investigator
mesh term: Depressive Disorder