<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/NCT02234258</url>
  </required_header>
  <id_info>
    <org_study_id>MH105178</org_study_id>
    <nct_id>NCT02234258</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis</brief_title>
  <official_title>Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Zucker Hillside Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses&#xD;
      that incur substantial suffering for patients and major challenges to the investigators&#xD;
      health care and legal systems. The prodrome is the period prior to onset of psychosis when&#xD;
      functional decline and clinical symptoms gradually emerge. The presence of a clinical&#xD;
      high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the&#xD;
      later development of psychosis, and for those who do not necessarily go on to develop a&#xD;
      psychotic illness, research has suggested that the majority continue to have fluctuating&#xD;
      subthreshold symptoms and poor social and role functioning. There are no specific treatments&#xD;
      to help with these functional difficulties. However, recent findings suggest that in people&#xD;
      with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to&#xD;
      significantly greater increase in the frequency of social functioning activities compared to&#xD;
      treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is&#xD;
      a feasible treatment for CHR. This proposal is a competitive application for a three-site,&#xD;
      longitudinal study aimed at testing the effectiveness and feasibility as well as mediators&#xD;
      and mechanisms of action of a manualized CBSST intervention that will target functional&#xD;
      difficulties associated with clinical risk states for psychosis. The goals are 1) to examine&#xD;
      whether CBSST compared to a placebo intervention (psychoeducation) matched for group&#xD;
      involvement and therapist time improves functioning in youth at CHR and 2) to determine&#xD;
      whether reduction in defeatist beliefs and improvement in social competence mediate change in&#xD;
      psychosocial functioning in CHR youth in the CBSST. In this single-blind randomized 2-arm&#xD;
      trial participants will be randomized to one of two treatments: CBSST, an 18-week group&#xD;
      comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or&#xD;
      a psychoeducation support group that does not teach active cognitive behavioral therapy or&#xD;
      social skills training. Over a five-year period, the multi-site collaboration will follow&#xD;
      large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral&#xD;
      changes, to examine changes in social and role functioning, as well as symptom changes from&#xD;
      baseline to the end of treatment, and to 6 month follow-up. This approach will demonstrate&#xD;
      the feasibility of a treatment for which it is easy to train therapists and which can readily&#xD;
      be disseminated to regular clinical community practice. In addition, it will provide insights&#xD;
      into likely approaches to halting or mitigating the pathological process and advance the&#xD;
      investigators understanding of risk prediction; both critical steps in prevention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">August 2021</completion_date>
  <primary_completion_date type="Actual">August 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Global Social Functioning Scale</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>This is a clinical rating scale that will be given to all participants at baseline, then 6 months which is the end of treatment and then 6 months after the end of treatment so approximately 12 months after baseline to determine if there is an improvement in social functioning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Defeatist Beliefs</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>This is a clinical rating scale that will be administer at the end of treatment (6 months) and 6 months after the end of treatment (12 months). This will be administered to all participants</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>At Risk of Psychosis</condition>
  <arm_group>
    <arm_group_label>Cognitive behavioral social skills</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Cognitive behavioral social skills training (CBSST), skills-based CBT is used to teach individuals how to correct inaccurate dysfunctional thoughts that interfere with goal-directed activities, including defeatist expectancies, low self-efficacy beliefs, and anomalous beliefs. SST focuses on behaviorally-based instruction of interpersonal social skills, utilizing role-modeling, rehearsal, corrective feedback, and positive reinforcement to facilitate learning. In the modified version of CBSST used in this project: 1) we will strengthen the focus on corrective feedback from successful social interactions; 2) focus on normalization and destigmatization of attenuated psychotic symptoms; 3) add motivational interviewing techniques to promote treatment engagement; and 4) use examples and role plays. CBSST will be delivered in three 6-session modules (i.e., Cognitive Skills, Social Skills, and Problem Solving Skills), a total of 18 90-minute group sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The purpose of this alternative treatment is to match CBSST for the nonspecific effects of therapist contact and interest, social interaction and support. Common factors include client expectancy, providing a rationale for change, therapist factors and therapeutic alliance. The psychoeducation group will meet weekly, for a total of 18 90-minute sessions. Therapists will follow brief guidelines as to what they can and cannot do. In each session the therapists will ask how the previous week had been. Any crises will be dealt with, and advice will be offered to help with any immediate problems. No active CBT or SST techniques will be taught or used. Psychoeducational information about high risk for psychosis will be offered. There will be a focus on listening, reflecting and empathizing, and demonstrating uncritical acceptance and genuineness. Social exchanges amongst participants will be encouraged.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral social skills</intervention_name>
    <arm_group_label>Cognitive behavioral social skills</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <arm_group_label>Psychoeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have prodromal criteria in the past 4 years&#xD;
&#xD;
          -  one attenuated psychotic symptom rated 3 or more&#xD;
&#xD;
          -  rating on social functioning &lt;6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  meet criteria for a psychotic disorder neurological disorder IQ&lt;70&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean M Addington, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mathison Centre for Research and Education, University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Jean Addington, PhD</investigator_full_name>
    <investigator_title>Dr Jean Addington</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</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/NCT02234258
org study id: MH105178
nct id: NCT02234258
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses
      that incur substantial suffering for patients and major challenges to the investigators
      health care and legal systems. The prodrome is the period prior to onset of psychosis when
      functional decline and clinical symptoms gradually emerge. The presence of a clinical
      high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the
      later development of psychosis, and for those who do not necessarily go on to develop a
      psychotic illness, research has suggested that the majority continue to have fluctuating
      subthreshold symptoms and poor social and role functioning. There are no specific treatments
      to help with these functional difficulties. However, recent findings suggest that in people
      with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to
      significantly greater increase in the frequency of social functioning activities compared to
      treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is
      a feasible treatment for CHR. This proposal is a competitive application for a three-site,
      longitudinal study aimed at testing the effectiveness and feasibility as well as mediators
      and mechanisms of action of a manualized CBSST intervention that will target functional
      difficulties associated with clinical risk states for psychosis. The goals are 1) to examine
      whether CBSST compared to a placebo intervention (psychoeducation) matched for group
      involvement and therapist time improves functioning in youth at CHR and 2) to determine
      whether reduction in defeatist beliefs and improvement in social competence mediate change in
      psychosocial functioning in CHR youth in the CBSST. In this single-blind randomized 2-arm
      trial participants will be randomized to one of two treatments: CBSST, an 18-week group
      comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or
      a psychoeducation support group that does not teach active cognitive behavioral therapy or
      social skills training. Over a five-year period, the multi-site collaboration will follow
      large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral
      changes, to examine changes in social and role functioning, as well as symptom changes from
      baseline to the end of treatment, and to 6 month follow-up. This approach will demonstrate
      the feasibility of a treatment for which it is easy to train therapists and which can readily
      be disseminated to regular clinical community practice. In addition, it will provide insights
      into likely approaches to halting or mitigating the pathological process and advance the
      investigators understanding of risk prediction; both critical steps in prevention.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the Global Social Functioning Scale
time frame: 6 and 12 months
description: This is a clinical rating scale that will be given to all participants at baseline, then 6 months which is the end of treatment and then 6 months after the end of treatment so approximately 12 months after baseline to determine if there is an improvement in social functioning
measure: Change in Defeatist Beliefs
time frame: 6 and 12 months
description: This is a clinical rating scale that will be administer at the end of treatment (6 months) and 6 months after the end of treatment (12 months). This will be administered to all participants
arm group label: Cognitive behavioral social skills
arm group type: Experimental
description: In Cognitive behavioral social skills training (CBSST), skills-based CBT is used to teach individuals how to correct inaccurate dysfunctional thoughts that interfere with goal-directed activities, including defeatist expectancies, low self-efficacy beliefs, and anomalous beliefs. SST focuses on behaviorally-based instruction of interpersonal social skills, utilizing role-modeling, rehearsal, corrective feedback, and positive reinforcement to facilitate learning. In the modified version of CBSST used in this project: 1) we will strengthen the focus on corrective feedback from successful social interactions; 2) focus on normalization and destigmatization of attenuated psychotic symptoms; 3) add motivational interviewing techniques to promote treatment engagement; and 4) use examples and role plays. CBSST will be delivered in three 6-session modules (i.e., Cognitive Skills, Social Skills, and Problem Solving Skills), a total of 18 90-minute group sessions.
arm group label: Psychoeducation
arm group type: Active Comparator
description: The purpose of this alternative treatment is to match CBSST for the nonspecific effects of therapist contact and interest, social interaction and support. Common factors include client expectancy, providing a rationale for change, therapist factors and therapeutic alliance. The psychoeducation group will meet weekly, for a total of 18 90-minute sessions. Therapists will follow brief guidelines as to what they can and cannot do. In each session the therapists will ask how the previous week had been. Any crises will be dealt with, and advice will be offered to help with any immediate problems. No active CBT or SST techniques will be taught or used. Psychoeducational information about high risk for psychosis will be offered. There will be a focus on listening, reflecting and empathizing, and demonstrating uncritical acceptance and genuineness. Social exchanges amongst participants will be encouraged.
intervention type: Behavioral
intervention name: Cognitive behavioral social skills
arm group label: Cognitive behavioral social skills
intervention type: Behavioral
intervention name: Psychoeducation
arm group label: Psychoeducation
criteria: 
gender: All
minimum age: 14 Years
maximum age: 30 Years
healthy volunteers: No
last name: Jean M Addington, PhD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Jean Addington, PhD
investigator title: Dr Jean Addington
mesh term: Psychotic Disorders
mesh term: Mental Disorders