<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/NCT02235649</url>
  </required_header>
  <id_info>
    <org_study_id>13/LO/1791</org_study_id>
    <nct_id>NCT02235649</nct_id>
  </id_info>
  <brief_title>Exploring the Feasibility of Social Skills Training in People With Psychosis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Psychiatry, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Psychiatry, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reduced social and community functioning is a predominant and enduring feature in people&#xD;
      experiencing severe mental illness such as psychosis. The large majority of interventions&#xD;
      (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and&#xD;
      delusions) but poorly address functional and social consequences of the illness.&#xD;
&#xD;
      This study attempts to fill this gap by assessing the feasibility and acceptability of a&#xD;
      psychological intervention targeting social cognition deficit in people with psychosis. The&#xD;
      intervention is a group psychological treatment facilitated by a clinical psychologist&#xD;
      targeting competencies such as emotion recognition, social situation appraisal and guessing&#xD;
      people's intentions and mental states. The group therapy takes advantage of audiovisual&#xD;
      material to illustrate strategies and thinking styles that may help participants to overcome&#xD;
      difficulties in social settings.&#xD;
&#xD;
      A second objective of this study is to test a new method to measure social cognition. Recent&#xD;
      research showed that interview and performance based tests are poorly associated with every&#xD;
      day activity of people with schizophrenia. This study is planning to evaluate the feasibility&#xD;
      of new assessment methods for social cognition in everyday life using portable electronic&#xD;
      devices (Experience Sampling Method and an activity watch). These devices will be carried by&#xD;
      participants in their everyday life and will ask about feelings and levels of social&#xD;
      activities at random times and record basic physiological and activity levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Feasibility and Acceptability</measure>
    <time_frame>10 weeks</time_frame>
    <description>Number of sessions attended and number of drop out from therapy. Acceptability is assesses with a questionnaire designed for psychological interventions (Gledhill et al., 1998).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness (i.e. social behaviour and social cognition)</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Focus of Study</condition>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOC+TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Social Cognition intervention + Treatment as Usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Cognition therapy ( Psychological Therapy)</intervention_name>
    <arm_group_label>SOC+TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnosis part of the psychosis spectrum (according to DSM-IV or DSM-V or ICD-10); age&#xD;
        18-65 yrs; good command of the English language; social engagement problems as evidenced by&#xD;
        care coordinator report and number of hours spent in social activities per week lower than&#xD;
        10.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Primary diagnosis of substance abuse disorder; change in antipsychotic medication in the&#xD;
        last six weeks; significant learning difficulties (premorbid IQ lower than 70).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Psychiatry, King's College London</name>
      <address>
        <city>London</city>
        <zip>SE5 8AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>April 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>December 4, 2019</last_update_submitted>
  <last_update_submitted_qc>December 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute of Psychiatry, London</investigator_affiliation>
    <investigator_full_name>Matteo Cella</investigator_full_name>
    <investigator_title>Lecturer in Clinical Psychology</investigator_title>
  </responsible_party>
  <!-- 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/NCT02235649
org study id: 13/LO/1791
nct id: NCT02235649
lead sponsor: 
has dmc: Yes
Reduced social and community functioning is a predominant and enduring feature in people
      experiencing severe mental illness such as psychosis. The large majority of interventions
      (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and
      delusions) but poorly address functional and social consequences of the illness.

      This study attempts to fill this gap by assessing the feasibility and acceptability of a
      psychological intervention targeting social cognition deficit in people with psychosis. The
      intervention is a group psychological treatment facilitated by a clinical psychologist
      targeting competencies such as emotion recognition, social situation appraisal and guessing
      people's intentions and mental states. The group therapy takes advantage of audiovisual
      material to illustrate strategies and thinking styles that may help participants to overcome
      difficulties in social settings.

      A second objective of this study is to test a new method to measure social cognition. Recent
      research showed that interview and performance based tests are poorly associated with every
      day activity of people with schizophrenia. This study is planning to evaluate the feasibility
      of new assessment methods for social cognition in everyday life using portable electronic
      devices (Experience Sampling Method and an activity watch). These devices will be carried by
      participants in their everyday life and will ask about feelings and levels of social
      activities at random times and record basic physiological and activity levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Feasibility and Acceptability
time frame: 10 weeks
description: Number of sessions attended and number of drop out from therapy. Acceptability is assesses with a questionnaire designed for psychological interventions (Gledhill et al., 1998).
measure: Effectiveness (i.e. social behaviour and social cognition)
time frame: 10 weeks
arm group label: TAU
arm group type: No Intervention
description: Treatment as usual
arm group label: SOC+TAU
arm group type: Active Comparator
description: Social Cognition intervention + Treatment as Usual
intervention type: Behavioral
intervention name: Social Cognition therapy ( Psychological Therapy)
arm group label: SOC+TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Institute of Psychiatry, London
investigator full name: Matteo Cella
investigator title: Lecturer in Clinical Psychology