<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/NCT03751865</url>
  </required_header>
  <id_info>
    <org_study_id>JCWowCBT</org_study_id>
    <secondary_id>UW 18-231</secondary_id>
    <nct_id>NCT03751865</nct_id>
  </id_info>
  <brief_title>Early Detection and Intervention for Women At-risk of Psychosis</brief_title>
  <official_title>Early Detection and Intervention for Women At-risk of Psychosis in Hong Kong: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to examine the effectiveness of the cognitive behavioral therapy in&#xD;
      preventing the conversion of psychosis in a sample of individuals at-risk for psychosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible subjects with informed consent provided will be randomly assigned to the cognitive&#xD;
      behavioural therapy (CBT) group or psychoeducation group. Each group consists of 8 session&#xD;
      spanning for 8 week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS)</measure>
    <time_frame>Changes from baseline to immediate, 6- and 12-month post-intervention</time_frame>
    <description>Measured by Social and Occupational Functioning Assessment Scale (SOFAS). The SOFAS is an observer rating scale. Ratings should be based on subject's behavior during the last 1 month. The score ranges from 0-100. A higher score represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functioning: Measured by Role Functioning Scale (RFS)</measure>
    <time_frame>Changes from baseline to immediate, 6- and 12-month post-intervention</time_frame>
    <description>Measured by Role Functioning Scale (RFS). The RFS is comprised of four single rating scaled for evaluating the functioning of individuals in specified areas of everyday life. The four role functions assessed are:(1)Working: productivity, (2) Independent living and self care, (3) Immediate social network relationships, and (4) Extended social network relationship. The values on each of the four scales range from 1 (minimal level of role functioning), to 7 (hypothetically optimal level of role functioning). Each of the seven points on the scales is accompanied by a behaviorally defined description.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conversion of psychosis</measure>
    <time_frame>12-month post-intervention</time_frame>
    <description>Proportion of subject that convert from at-risk state to psychosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive psychotic symptoms</measure>
    <time_frame>Immediate, 6- and 12-month post-intervention</time_frame>
    <description>Measurement of positive symptoms using the Chinese version of the Psychotic Symptom Rating Scales (C-PSYRATS). It comprises of the auditory hallucinations (AHS) and delusions subscales (DS). The AHS has 11 questions and the DS consists of 6 questions, each question has the responses ranging from 0-4. The higher score represents more severe positive psychotic symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beliefs about the auditory hallucination</measure>
    <time_frame>Immediate, 6- and 12-month post-intervention</time_frame>
    <description>Measured by the Beliefs About Voices Questionnaire (BAVQ-R). The BAVQ-R has 35 questions, the 4 responses range from disagree, unsure, slightly agree to strongly agree. The higher score represents more convicted belief about the voices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>Immediate, 6- and 12-month post-intervention</time_frame>
    <description>Measured by the Calgary Depression Scale for Schizophrenia (CDSS). The scale consists of 9 questions, each has the response ranging from 0 to 3. The higher score presents more severe depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social anxiety :Measured by Liebowitz Social Anxiety Scale (LSAS)</measure>
    <time_frame>Immediate, 6- and 12-month post-intervention</time_frame>
    <description>Measured by Liebowitz Social Anxiety Scale (LSAS). The LSAS consists of 24 questions, the rater has to rate from 0-3 in Fear or Anxiety domain or Avoidance domain for each of the 24 questions. The higher score represents more severe social anxiety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Prodromal Schizophrenia</condition>
  <arm_group>
    <arm_group_label>CBT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention aims for distress reduction, symptom coping, and life quality enhancement. It is a gender-specific CBT tailor-made for the at-risk population. The intervention is delivered by a registered clinical psychologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The content of the psycho-education program will be related to healthy living content and mental health knowledge, such as food hygiene, psychological well-being, knowledge about psychosis and common mental disorder and food nutrition. In addition, a weekly call to remind the subject about healthy living will also be provided to the subjects. The intervention is delivered by a registered social worker.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT</intervention_name>
    <description>A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.</description>
    <arm_group_label>CBT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <description>A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.</description>
    <arm_group_label>Psychoeducation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women of age 18-64&#xD;
&#xD;
          -  at-risk mental state as defined by the Comprehensive Assessment of At-Risk Mental&#xD;
             States (CAARMS)&#xD;
&#xD;
          -  with an informed consent&#xD;
&#xD;
          -  able to understand Cantonese and read/write Chinese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those mental conditions that requires other treatment priorities (e.g., suicidal risk,&#xD;
             substance abuse, current or past episodes of psychotic disorder, personality&#xD;
             disorders)&#xD;
&#xD;
          -  those medical conditions that severely limits participation, comprehension, or&#xD;
             adherence to the treatment (e.g., epilepsy, dementia, terminal medical illness);&#xD;
&#xD;
          -  those who are receiving structured psychotherapy or counselling&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Yu Hai Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi Nam Suen, PhD</last_name>
    <phone>3917 9579</phone>
    <email>suenyn@hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pui Sze Jade Wong</last_name>
    <phone>2831 5344</phone>
    <email>jadewps@hku.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <zip>0000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Nam Suen</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 18, 2021</last_update_submitted>
  <last_update_submitted_qc>April 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Professor Eric Y.H. Chen</investigator_full_name>
    <investigator_title>Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03751865
org study id: JCWowCBT
secondary id: UW 18-231
nct id: NCT03751865
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to examine the effectiveness of the cognitive behavioral therapy in
      preventing the conversion of psychosis in a sample of individuals at-risk for psychosis.
Eligible subjects with informed consent provided will be randomly assigned to the cognitive
      behavioural therapy (CBT) group or psychoeducation group. Each group consists of 8 session
      spanning for 8 week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS)
time frame: Changes from baseline to immediate, 6- and 12-month post-intervention
description: Measured by Social and Occupational Functioning Assessment Scale (SOFAS). The SOFAS is an observer rating scale. Ratings should be based on subject's behavior during the last 1 month. The score ranges from 0-100. A higher score represents a better outcome.
measure: Functioning: Measured by Role Functioning Scale (RFS)
time frame: Changes from baseline to immediate, 6- and 12-month post-intervention
description: Measured by Role Functioning Scale (RFS). The RFS is comprised of four single rating scaled for evaluating the functioning of individuals in specified areas of everyday life. The four role functions assessed are:(1)Working: productivity, (2) Independent living and self care, (3) Immediate social network relationships, and (4) Extended social network relationship. The values on each of the four scales range from 1 (minimal level of role functioning), to 7 (hypothetically optimal level of role functioning). Each of the seven points on the scales is accompanied by a behaviorally defined description.
measure: Conversion of psychosis
time frame: 12-month post-intervention
description: Proportion of subject that convert from at-risk state to psychosis
measure: Positive psychotic symptoms
time frame: Immediate, 6- and 12-month post-intervention
description: Measurement of positive symptoms using the Chinese version of the Psychotic Symptom Rating Scales (C-PSYRATS). It comprises of the auditory hallucinations (AHS) and delusions subscales (DS). The AHS has 11 questions and the DS consists of 6 questions, each question has the responses ranging from 0-4. The higher score represents more severe positive psychotic symptoms.
measure: Beliefs about the auditory hallucination
time frame: Immediate, 6- and 12-month post-intervention
description: Measured by the Beliefs About Voices Questionnaire (BAVQ-R). The BAVQ-R has 35 questions, the 4 responses range from disagree, unsure, slightly agree to strongly agree. The higher score represents more convicted belief about the voices.
measure: Depressive symptoms
time frame: Immediate, 6- and 12-month post-intervention
description: Measured by the Calgary Depression Scale for Schizophrenia (CDSS). The scale consists of 9 questions, each has the response ranging from 0 to 3. The higher score presents more severe depressive symptoms.
measure: Social anxiety :Measured by Liebowitz Social Anxiety Scale (LSAS)
time frame: Immediate, 6- and 12-month post-intervention
description: Measured by Liebowitz Social Anxiety Scale (LSAS). The LSAS consists of 24 questions, the rater has to rate from 0-3 in Fear or Anxiety domain or Avoidance domain for each of the 24 questions. The higher score represents more severe social anxiety.
arm group label: CBT group
arm group type: Experimental
description: This intervention aims for distress reduction, symptom coping, and life quality enhancement. It is a gender-specific CBT tailor-made for the at-risk population. The intervention is delivered by a registered clinical psychologist.
arm group label: Psychoeducation group
arm group type: Active Comparator
description: The content of the psycho-education program will be related to healthy living content and mental health knowledge, such as food hygiene, psychological well-being, knowledge about psychosis and common mental disorder and food nutrition. In addition, a weekly call to remind the subject about healthy living will also be provided to the subjects. The intervention is delivered by a registered social worker.
intervention type: Behavioral
intervention name: CBT
description: A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
arm group label: CBT group
intervention type: Behavioral
intervention name: Psychoeducation
description: A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
arm group label: Psychoeducation group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Eric Yu Hai Chen, MD
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Yi Nam Suen, PhD
phone: 3917 9579
email: suenyn@hku.hk
last name: Pui Sze Jade Wong
phone: 2831 5344
email: jadewps@hku.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Professor Eric Y.H. Chen
investigator title: Chi-li Pao Foundation Professor of Psychiatry; Chair Professor in Psychiatry; Head, Department of Psychiatry
mesh term: Schizophrenia
sharing ipd: No