xml: <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/NCT06014476</url>
    </required_header>
    <id_info>
      <org_study_id>Hangzhou Normal University</org_study_id>
      <nct_id>NCT06014476</nct_id>
    </id_info>
    <brief_title>Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness</brief_title>
    <official_title>Psychological Symptoms and Burden in Caregivers of Patients With Disorders of Consciousness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hangzhou Normal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hangzhou Normal 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>
        Caregivers of patients with disorders of consciousness are highly prone to developing mental&#xD;
        health issues. The aim of this study is to investigate the psychological symptoms and care&#xD;
        burden of caregivers of patients with disorders of consciousness (DoC), and to examine which&#xD;
        characteristics of patients were burden predictors to caregivers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center cross-sectional study in China, from August 2021 to October 2022.&#xD;
        Patients were assessed by Coma Recovery Scale-Revised (CRS-R), and caregivers' anxiety,&#xD;
        depression, and burden were assessed by State-Trait Anxiety Inventory Form Y (STAI), Beck&#xD;
        Depression Inventory-II (BDI- II), and Zarit Caregiver Burden scale (ZBI). The comparison&#xD;
        with patients' age and caregivers' age-matched subjects who were randomly selected and&#xD;
        without DoC; intra-group comparison of caregivers for DoC was conducted. Descriptive&#xD;
        statistics were used to illustrate the socio-demographics. One-sample t-test, independent&#xD;
        sample t-test, one-way ANOVA, Mann-Whitney U test, and Kruskal-Wallis test were executed to&#xD;
        detect the difference between groups due to the distribution of each variable.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2021</start_date>
    <completion_date type="Actual">October 31, 2022</completion_date>
    <primary_completion_date type="Actual">October 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Family-Based</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The prevalence of anxiety in caregivers of patients with disorders of consciousness.</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We use the State-Trait Anxiety Inventory Form Y (STAI-Y) to assess the prevalence and severity degree of anxiety for caregivers of patients with disorders of consciousness (DoC)&#xD;
  STAI was a self-rating scale, consisting of 40 items and divided into two subscales: 1) state anxiety (S-AI) scale includes questions 1-20, state anxiety shows the transitory unpleasant. 2) trait anxiety (T-AI) scale includes questions 21-40, trait anxiety tends to the personality trait. The cumulative score values of state anxiety and trait anxiety scales were calculated respectively, the minimum to maximum value was from 20 to 80, the higher scores mean a worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We use the Beck Depression Inventory-II (BDI-II) to assess the prevalence and severity degree of depression for caregivers of patients with disorders of consciousness (DoC)&#xD;
  BDI total score: 0-13 as no depression, 14-19 as mild depression, 20-28 as medium depression, and 29-63 as severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The prevalence and severity degree of burden in caregivers of patients with disorders of consciousness.</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We use the Zarit Caregiver Burden Scale (ZBI) to assess the prevalence and severity degree of burden for caregivers of patients with disorders of consciousness (DoC)&#xD;
  ZBI total score: 0-20 indicates no burden, 21-40 mild burden, 41-60 moderate burden, and 61-88 severe burden.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The predictors of anxiety in caregivers of patients with disorders of consciousness.</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We choose a series of questionnaires to figure out: what are the characteristics of patients and caregivers were caregivers' anxiety predictors?&#xD;
  The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information) and the State-Trait Anxiety Inventory Form Y (STAI-Y).&#xD;
  We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The predictors of depression in caregivers of patients with disorders of consciousness.</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We choose a series of questionnaires to figure out:&#xD;
  (1) What are the characteristics of patients and caregivers were caregivers' depression predictors?&#xD;
  The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Beck Depression Inventory-II (BDI-II).&#xD;
  We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The predictors of burden in caregivers of patients with disorders of consciousness.</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We choose a series of questionnaires to figure out:&#xD;
  (1) What are the characteristics of patients and caregivers were caregivers' burden predictors?&#xD;
  The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Zarit Caregiver Burden Scale (ZBI).&#xD;
  We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' burden.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The diagnoses of patients with disorders of consciousness (DoC)</measure>
      <time_frame>Within 10 days</time_frame>
      <description>The DoC patients were evaluated 3-5 times Coma Recovery Scale-Revised (CRS-R) within 10 days after questionnaire distribution to determine their current state of consciousness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The relationship between patient diagnoses and caregivers' anxiety</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' anxiety (assessed by the State-Trait Anxiety Inventory Form Y (STAI-Y) )&#xD;
  We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The relationship between patient diagnoses and caregivers' depression</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Beck Depression Inventory-II (BDI-II) )&#xD;
  We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The relationship between patient diagnoses and caregivers' burden</measure>
      <time_frame>Within 1 days</time_frame>
      <description>We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Zarit Caregiver Burden Scale (ZBI) )&#xD;
  We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' burden.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">256</enrollment>
    <condition>Psychological Distress</condition>
    <condition>Anxiety Depression</condition>
    <condition>Burden, Caregiver</condition>
    <condition>Disorders of Consciousness</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <description>Caregivers of patients with disorders of consciousness, including Coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Consciousness State (MCS). And caregivers of patients emerge from the minimally conscious state (EMCS)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>caregivers of patients with other disease</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>questionnaires</intervention_name>
      <description>Sent questionnaires to caregivers and used CRS-R to assess patients with DoC</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Experimental Group</arm_group_label>
      <other_name>Coma Recovery Scale-Revised (CRS-R)</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Caregivers of patients with DoC and other diseases&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - (1) Family caregivers without neurological, mental health, or learning disability&#xD;
          history.&#xD;
  &#xD;
          (2) Family caregiver with consciousness and capability of independently completing&#xD;
          questionnaires.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Caregivers unwilling to participate&#xD;
  &#xD;
            2. Not the dominant caregivers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>81 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hao YA Wang</last_name>
      <role>Study Chair</role>
      <affiliation>Hangzhou Normal University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>International Vegetative State and Consciousness Science Institute, Hangzhou Normal University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hangzhou Normal University</investigator_affiliation>
      <investigator_full_name>Haibo Di</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>Consciousness Disorders</mesh_term>
      <mesh_term>Caregiver Burden</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014476
  org study id: Hangzhou Normal University
  nct id: NCT06014476
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Caregivers of patients with disorders of consciousness are highly prone to developing mental
        health issues. The aim of this study is to investigate the psychological symptoms and care
        burden of caregivers of patients with disorders of consciousness (DoC), and to examine which
        characteristics of patients were burden predictors to caregivers.
  This is a multi-center cross-sectional study in China, from August 2021 to October 2022.
        Patients were assessed by Coma Recovery Scale-Revised (CRS-R), and caregivers' anxiety,
        depression, and burden were assessed by State-Trait Anxiety Inventory Form Y (STAI), Beck
        Depression Inventory-II (BDI- II), and Zarit Caregiver Burden scale (ZBI). The comparison
        with patients' age and caregivers' age-matched subjects who were randomly selected and
        without DoC; intra-group comparison of caregivers for DoC was conducted. Descriptive
        statistics were used to illustrate the socio-demographics. One-sample t-test, independent
        sample t-test, one-way ANOVA, Mann-Whitney U test, and Kruskal-Wallis test were executed to
        detect the difference between groups due to the distribution of each variable.
  observational model: Family-Based
  time perspective: Cross-Sectional
  measure: The prevalence of anxiety in caregivers of patients with disorders of consciousness.
  time frame: Within 1 days
  description: We use the State-Trait Anxiety Inventory Form Y (STAI-Y) to assess the prevalence and severity degree of anxiety for caregivers of patients with disorders of consciousness (DoC)
  STAI was a self-rating scale, consisting of 40 items and divided into two subscales: 1) state anxiety (S-AI) scale includes questions 1-20, state anxiety shows the transitory unpleasant. 2) trait anxiety (T-AI) scale includes questions 21-40, trait anxiety tends to the personality trait. The cumulative score values of state anxiety and trait anxiety scales were calculated respectively, the minimum to maximum value was from 20 to 80, the higher scores mean a worse outcome.
  measure: The prevalence and severity degree of depression in caregivers of patients with disorders of consciousness.
  time frame: Within 1 days
  description: We use the Beck Depression Inventory-II (BDI-II) to assess the prevalence and severity degree of depression for caregivers of patients with disorders of consciousness (DoC)
  BDI total score: 0-13 as no depression, 14-19 as mild depression, 20-28 as medium depression, and 29-63 as severe depression.
  measure: The prevalence and severity degree of burden in caregivers of patients with disorders of consciousness.
  time frame: Within 1 days
  description: We use the Zarit Caregiver Burden Scale (ZBI) to assess the prevalence and severity degree of burden for caregivers of patients with disorders of consciousness (DoC)
  ZBI total score: 0-20 indicates no burden, 21-40 mild burden, 41-60 moderate burden, and 61-88 severe burden.
  measure: The predictors of anxiety in caregivers of patients with disorders of consciousness.
  time frame: Within 1 days
  description: We choose a series of questionnaires to figure out: what are the characteristics of patients and caregivers were caregivers' anxiety predictors?
  The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information) and the State-Trait Anxiety Inventory Form Y (STAI-Y).
  We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' anxiety.
  measure: The predictors of depression in caregivers of patients with disorders of consciousness.
  time frame: Within 1 days
  description: We choose a series of questionnaires to figure out:
  (1) What are the characteristics of patients and caregivers were caregivers' depression predictors?
  The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Beck Depression Inventory-II (BDI-II).
  We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' depression.
  measure: The predictors of burden in caregivers of patients with disorders of consciousness.
  time frame: Within 1 days
  description: We choose a series of questionnaires to figure out:
  (1) What are the characteristics of patients and caregivers were caregivers' burden predictors?
  The questionnaires include social-demographic questionnaires (including personal information of patients and caregivers e.g., age, gender, etiology, diagnosis, and so on, to record their basic information), and the Zarit Caregiver Burden Scale (ZBI).
  We used the Independent-sample T-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis test, and Pearson Correlation to calculate the correlation between the characteristics of patients and caregivers and caregivers' burden.
  measure: The diagnoses of patients with disorders of consciousness (DoC)
  time frame: Within 10 days
  description: The DoC patients were evaluated 3-5 times Coma Recovery Scale-Revised (CRS-R) within 10 days after questionnaire distribution to determine their current state of consciousness.
  measure: The relationship between patient diagnoses and caregivers' anxiety
  time frame: Within 1 days
  description: We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' anxiety (assessed by the State-Trait Anxiety Inventory Form Y (STAI-Y) )
  We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' anxiety.
  measure: The relationship between patient diagnoses and caregivers' depression
  time frame: Within 1 days
  description: We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Beck Depression Inventory-II (BDI-II) )
  We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' depression.
  measure: The relationship between patient diagnoses and caregivers' burden
  time frame: Within 1 days
  description: We compare patient diagnoses (assessed by Coma Recovery Scale-Revised (CRS-R) ) and caregivers' depression (assessed by the Zarit Caregiver Burden Scale (ZBI) )
  We used the one-way ANOVA to calculate the relationship between patient diagnoses and caregivers' burden.
  arm group label: Experimental Group
  description: Caregivers of patients with disorders of consciousness, including Coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Consciousness State (MCS). And caregivers of patients emerge from the minimally conscious state (EMCS)
  arm group label: Control group
  description: caregivers of patients with other disease
  intervention type: Other
  intervention name: questionnaires
  description: Sent questionnaires to caregivers and used CRS-R to assess patients with DoC
  arm group label: Control group
  arm group label: Experimental Group
  other name: Coma Recovery Scale-Revised (CRS-R)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: 81 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hao YA Wang
  role: Study Chair
  affiliation: Hangzhou Normal University
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Hangzhou Normal University
  investigator full name: Haibo Di
  investigator title: Principal Investigator
  mesh term: Consciousness Disorders
  mesh term: Caregiver Burden
  sharing ipd: No