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/NCT06032182</url>
    </required_header>
    <id_info>
      <org_study_id>NUIRELAND2</org_study_id>
      <nct_id>NCT06032182</nct_id>
    </id_info>
    <brief_title>PSYCHE Cognitive Remediation &amp; Social Recovery Study</brief_title>
    <official_title>PSYCHE Cognitive Remediation &amp; Social Recovery in Early Psychosis Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National University of Ireland, Galway, Ireland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Health Service Executive, Ireland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Health Research Board, Ireland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National University of Ireland, Galway, Ireland</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 is a pilot feasibility study embedded in the Early Intervention in Psychosis (EIP)&#xD;
        services in Ireland. It explores the feasibility and acceptability of a combined cognitive&#xD;
        remediation training and social recovery therapy intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Cognitive Remediation and Social Recovery in Early Psychosis (CRESTR) study is a&#xD;
        feasibility study recruiting participants from the Health Service Executive Early&#xD;
        Intervention in Psychosis (EIP) services in Sligo, Meath and Cork and the Adult Mental Heath&#xD;
        Service in Galway. This study explores the feasibility and acceptability of a novel, 15-week&#xD;
        multicomponent psychosocial intervention which combines cognitive remediation training (CRT)&#xD;
        and social recovery therapy (SRT). Primary and secondary outcome measures are described later&#xD;
        in this registration. The intervention components include:&#xD;
  &#xD;
        Component 1: The CRT programme used in this study is the Computerised Interactive Remediation&#xD;
        of Cognition- Training for Schizophrenia (CIRCuiTS). CIRCuiTS is a web-based CRT programme&#xD;
        which targets metacognition, specifically strategy use, in addition to massed practice of&#xD;
        cognitive functions (attention, memory and executive functioning). Collaborative goal setting&#xD;
        related to real-world tasks are integral to the programme with the programme tasks and&#xD;
        exercises increasing in difficulty in response to the participant's performance and progress.&#xD;
        This will be the primary focus of 1:1 therapy for the first 7 weeks with remote practice&#xD;
        sessions occurring between therapy visits. After 7 weeks remote practice will continue and&#xD;
        the focus of in-person therapy sessions will bridge to social recovery therapy as detailed&#xD;
        below.&#xD;
  &#xD;
        Component 2: Social recovery therapy (SRT) focuses on addressing barriers to individuals&#xD;
        interacting in their social environment e.g., social anxiety. It is informed by cognitive&#xD;
        behavioural theory and addresses individual goals. SRT follows an established protocol. In&#xD;
        summary, this consists of therapy delivered in three stages. Stage one will include&#xD;
        engagement and formulation with the purpose of identifying a problem list and establishing a&#xD;
        therapeutic relationship. Stage two will include preparing for new activities with&#xD;
        identification of pathways to activity and collaboration with community stakeholders. Stage&#xD;
        three will include engagement in new activities using behavioural experiments to promote&#xD;
        social activity. This is the primary focus of in-person therapy sessions from week 8 to 15&#xD;
        alongside remote practice of the CRT programme.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>Social and Occupational Functioning Assessment Scale (SOFAS)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>Social and Occupational Functional Assessment Scale (SOFAS) (Rybarczyk, 2011) is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Functioning Scale (GFS)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The Global Functioning Scale: Social (GFS) measures social skills and relationships within and outside of the family, and the Global Functioning Scale: Role (GFR) assesses performance in a person's primary role (typically student or worker).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MIRECC GAF</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>Measures occupational functioning, social functioning, and symptom severity on 3 subscales. 3 subscales scored from 0 to 100, with higher scores indicating better functioning</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Assessment of Function (GAF)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The GAF scale is a 100-point single-item scale designed to measure the global severity of psychiatric illness on the basis of symptom, social, and occupational functioning combined. The scale is divided into 10 anchor intervals, with descriptions and examples of symptoms and of social and occupational functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time Use Survey (TUS)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The TUS is a semi-structured interview that enquires about time spent over the past month on work, education, voluntary work, leisure, sports, housework or chores, and child care. Time spent on each of the activities is calculated in terms of the average number of hours per week. The activities are summed to create two scores: constructive economic activity (work, education, voluntary work, housework or chores, and child care) and structured activity (constructive economic activity plus leisure and sports activities). Less than 45 hours of structured activity per week is considered a threshold for being at risk of social disability, less than 30 hours per week is threshold for social disability and indicative of poor social functioning, and less than 15 hours per week is considered to reflect serious social disability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Reading the Mind in the Eyes Task</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The Reading the mind in the eyes task is a theory of mind task that measures the capacity to understand mental states of others from expressions in the eye region of the face. Participants view 36 photos and choose the most accurate descriptor word from four choices for the thought/feeling that was portrayed. Scores range from 0 to 36 with higher scores indicating better theory of mind ability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotion Recognition Task (CANTAB ERT)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The Emotion Recognition Task (ERT) from the Cambridge Neuropsychological Test Automated Battery (Cambridge Cognition Ltd.)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Bell Lysaker Emotion Recognition Task (BLERT)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The Bell Lysaker Emotion Recognition Task (BLERT) measures recognition of seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion. Participants identified the emotion shown in 21 videos of a male actor providing dynamic facial, vocal-tonal, and upper-body movement cues. Performance is indexed as the total number of correctly identified emotions (ranging from 0 to 21).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Test of Premorbid Functioning (TOPF)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>Test of Premorbid Functioning estimates an individual's pre-morbid cognitive and memory functioning. A revised and updated version of the Wechsler Test of Adult Reading™, TOPF helps predict pre-injury IQ and memory abilities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The matrix reasoning subtest from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The matrix reasoning subtest from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III) (Wechsler, 1997) is a brief, reliable measure of cognitive ability for use in clinical, educational and research settings. Matrix reasoning subtest scores range from 0 - 26 with higher scores reflecting better perceptual organization. Once raw scores are derived they are converted to scaled scores adjusted for age.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Letter Number Sequencing Task</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The letter-number sequencing task from the Wechsler Memory scale 3rd edition WMS-III assesses working memory. Scores range from 0-21. Higher scores on the WMS-III subtests indicate better memory function. Raw scores are converted to scaled scores adjusted for age.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Metacognitive Awareness Scale, Domain Specific (MCAS-DS)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>Meta-Cognitive Awareness Scale - Domain Specific (MCAS-DS) encourages reflection of task strategy processes. This domain-specific scale was first constructed to measure participants' awareness of their own metacognition linked to Raven's Progressive Matrices (SPM). Following discriminatory index and Exploratory Factor Analysis, a 15-item scale was derived. Exploratory Factor Analysis showed five factors: Awareness of Engagement in Self-Monitoring, Awareness of Own Ability, Awareness of Responding Speed/Time, Awareness of Alternative Solutions and Awareness of Requisite Problem-Solving Resources.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scale for the assessment of positive symptoms (SAPS) and negative symptoms (SANS)</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>Assessment of positive and negative symptomology</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PHQ-9</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The Patient Health Questionnaire (PHQ-9) is a brief tool used to diagnose and measure severity of depression. The PHQ-9 is shorter than many of the other depression screening instruments and can be self-administered. Adapted from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), the PHQ-9 is comprised of the same diagnostic symptom criteria used in the DSM-IV:&#xD;
  Two cardinal signs of depression (anhedonia and depressed mood); Cognitions (e.g. guilt/worthlessness and suicidality/thoughts of death); and Physical symptoms (e.g. change in appetite, difficulty sleeping and concentrating, feeling tired/slowed down or restless).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GAD-7</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DUDIT</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The DUDIT is an 11-item self-administered screening instrument for drug-related problems, giving information on the level of drug intake and selected criteria for substance abuse/harmful use and dependence according to the ICD-10 and DSM-4 diagnostic systems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUDIT</measure>
      <time_frame>T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)</time_frame>
      <description>The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Early Psychosis</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>15 sessions of the combined cognitive remediation training and social recovery therapy intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>15 sessions of social recovery therapy alone.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CRESTR Intervention</intervention_name>
      <description>15 1-hour sessions of CRT + SRT</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CRESTR Control</intervention_name>
      <description>15 1-hour sessions of SRT alone</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged between 18 and 60 years of age&#xD;
  &#xD;
            -  Within the first 5 years of a diagnosed psychotic disorder&#xD;
  &#xD;
            -  Community based and clinically stable&#xD;
  &#xD;
            -  Ability to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of organic impairment&#xD;
  &#xD;
            -  IQ&lt; 70&#xD;
  &#xD;
            -  History of head injury with loss of consciousness &gt; 5-minute duration&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Prof. Gary Donohoe</last_name>
      <phone>0035391495122</phone>
      <email>gary.donohoe@universityofgalway.ie</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dr Emma Frawley</last_name>
      <phone>0035391495953</phone>
      <email>emma.frawley@universityofgalway.ie</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>HSE Early Intervention in Psychosis Service, Cork</name>
        <address>
          <city>Cork</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr Karen O'Connor</last_name>
        <phone>0035321 4233164</phone>
        <email>karen.oconnor3@hse.ie</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Adult Mental Health Service, University Hospital Galway</name>
        <address>
          <city>Galway</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr Brian Hallahan</last_name>
        <phone>0035391524222</phone>
        <phone_ext>4162</phone_ext>
        <email>brian.hallahan@universityofgalway.ie</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>HSE Early Intervention in Psychosis Service, Meath</name>
        <address>
          <city>Meath</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr Marie Whitty</last_name>
        <email>marie.whitty@hse.ie</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>HSE Early Intervention in Psychosis Service, Sligo</name>
        <address>
          <city>Sligo</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr Donagh O'Neil</last_name>
        <email>donagh.oneill@hse.ie</email>
      </contact>
    </location>
    <location_countries>
      <country>Ireland</country>
    </location_countries>
    <reference>
      <citation>Frawley E, Cowman M, Cella M, Cohen D, Ryan E, Hallahan B, Bowie C, McDonald C, Fowler D, Wykes T, Donohoe G. Cognitive Remediation and Social Recovery in Early Psychosis (CReSt-R): protocol for a pilot randomised controlled study. Pilot Feasibility Stud. 2022 May 24;8(1):109. doi: 10.1186/s40814-022-01064-6.</citation>
      <PMID>35610711</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National University of Ireland, Galway, Ireland</investigator_affiliation>
      <investigator_full_name>Gary Donohoe</investigator_full_name>
      <investigator_title>Professor Gary Donohoe</investigator_title>
    </responsible_party>
    <keyword>Recovery</keyword>
    <keyword>Cognitive remediation training</keyword>
    <keyword>Cognitive behavioural therapy</keyword>
    <keyword>Psychosis</keyword>
    <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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The full protocol in addition to datasets and statistical code generated during the current study will be available from the corresponding author on reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_access_criteria>The full protocol in addition to datasets and statistical code generated during the current study will be available from the corresponding author on reasonable request.</ipd_access_criteria>
    </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/NCT06032182
  org study id: NUIRELAND2
  nct id: NCT06032182
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a pilot feasibility study embedded in the Early Intervention in Psychosis (EIP)
        services in Ireland. It explores the feasibility and acceptability of a combined cognitive
        remediation training and social recovery therapy intervention.
  The Cognitive Remediation and Social Recovery in Early Psychosis (CRESTR) study is a
        feasibility study recruiting participants from the Health Service Executive Early
        Intervention in Psychosis (EIP) services in Sligo, Meath and Cork and the Adult Mental Heath
        Service in Galway. This study explores the feasibility and acceptability of a novel, 15-week
        multicomponent psychosocial intervention which combines cognitive remediation training (CRT)
        and social recovery therapy (SRT). Primary and secondary outcome measures are described later
        in this registration. The intervention components include:
  
        Component 1: The CRT programme used in this study is the Computerised Interactive Remediation
        of Cognition- Training for Schizophrenia (CIRCuiTS). CIRCuiTS is a web-based CRT programme
        which targets metacognition, specifically strategy use, in addition to massed practice of
        cognitive functions (attention, memory and executive functioning). Collaborative goal setting
        related to real-world tasks are integral to the programme with the programme tasks and
        exercises increasing in difficulty in response to the participant's performance and progress.
        This will be the primary focus of 1:1 therapy for the first 7 weeks with remote practice
        sessions occurring between therapy visits. After 7 weeks remote practice will continue and
        the focus of in-person therapy sessions will bridge to social recovery therapy as detailed
        below.
  
        Component 2: Social recovery therapy (SRT) focuses on addressing barriers to individuals
        interacting in their social environment e.g., social anxiety. It is informed by cognitive
        behavioural theory and addresses individual goals. SRT follows an established protocol. In
        summary, this consists of therapy delivered in three stages. Stage one will include
        engagement and formulation with the purpose of identifying a problem list and establishing a
        therapeutic relationship. Stage two will include preparing for new activities with
        identification of pathways to activity and collaboration with community stakeholders. Stage
        three will include engagement in new activities using behavioural experiments to promote
        social activity. This is the primary focus of in-person therapy sessions from week 8 to 15
        alongside remote practice of the CRT programme.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Social and Occupational Functioning Assessment Scale (SOFAS)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: Social and Occupational Functional Assessment Scale (SOFAS) (Rybarczyk, 2011) is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.
  measure: Global Functioning Scale (GFS)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The Global Functioning Scale: Social (GFS) measures social skills and relationships within and outside of the family, and the Global Functioning Scale: Role (GFR) assesses performance in a person's primary role (typically student or worker).
  measure: MIRECC GAF
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: Measures occupational functioning, social functioning, and symptom severity on 3 subscales. 3 subscales scored from 0 to 100, with higher scores indicating better functioning
  measure: Global Assessment of Function (GAF)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The GAF scale is a 100-point single-item scale designed to measure the global severity of psychiatric illness on the basis of symptom, social, and occupational functioning combined. The scale is divided into 10 anchor intervals, with descriptions and examples of symptoms and of social and occupational functioning.
  measure: Time Use Survey (TUS)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The TUS is a semi-structured interview that enquires about time spent over the past month on work, education, voluntary work, leisure, sports, housework or chores, and child care. Time spent on each of the activities is calculated in terms of the average number of hours per week. The activities are summed to create two scores: constructive economic activity (work, education, voluntary work, housework or chores, and child care) and structured activity (constructive economic activity plus leisure and sports activities). Less than 45 hours of structured activity per week is considered a threshold for being at risk of social disability, less than 30 hours per week is threshold for social disability and indicative of poor social functioning, and less than 15 hours per week is considered to reflect serious social disability.
  measure: The Reading the Mind in the Eyes Task
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The Reading the mind in the eyes task is a theory of mind task that measures the capacity to understand mental states of others from expressions in the eye region of the face. Participants view 36 photos and choose the most accurate descriptor word from four choices for the thought/feeling that was portrayed. Scores range from 0 to 36 with higher scores indicating better theory of mind ability.
  measure: Emotion Recognition Task (CANTAB ERT)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The Emotion Recognition Task (ERT) from the Cambridge Neuropsychological Test Automated Battery (Cambridge Cognition Ltd.)
  measure: The Bell Lysaker Emotion Recognition Task (BLERT)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The Bell Lysaker Emotion Recognition Task (BLERT) measures recognition of seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion. Participants identified the emotion shown in 21 videos of a male actor providing dynamic facial, vocal-tonal, and upper-body movement cues. Performance is indexed as the total number of correctly identified emotions (ranging from 0 to 21).
  measure: Test of Premorbid Functioning (TOPF)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: Test of Premorbid Functioning estimates an individual's pre-morbid cognitive and memory functioning. A revised and updated version of the Wechsler Test of Adult Reading™, TOPF helps predict pre-injury IQ and memory abilities.
  measure: The matrix reasoning subtest from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The matrix reasoning subtest from the Wechsler Adult Scale of Intelligence 3rd edition (WAIS-III) (Wechsler, 1997) is a brief, reliable measure of cognitive ability for use in clinical, educational and research settings. Matrix reasoning subtest scores range from 0 - 26 with higher scores reflecting better perceptual organization. Once raw scores are derived they are converted to scaled scores adjusted for age.
  measure: Letter Number Sequencing Task
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The letter-number sequencing task from the Wechsler Memory scale 3rd edition WMS-III assesses working memory. Scores range from 0-21. Higher scores on the WMS-III subtests indicate better memory function. Raw scores are converted to scaled scores adjusted for age.
  measure: Metacognitive Awareness Scale, Domain Specific (MCAS-DS)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: Meta-Cognitive Awareness Scale - Domain Specific (MCAS-DS) encourages reflection of task strategy processes. This domain-specific scale was first constructed to measure participants' awareness of their own metacognition linked to Raven's Progressive Matrices (SPM). Following discriminatory index and Exploratory Factor Analysis, a 15-item scale was derived. Exploratory Factor Analysis showed five factors: Awareness of Engagement in Self-Monitoring, Awareness of Own Ability, Awareness of Responding Speed/Time, Awareness of Alternative Solutions and Awareness of Requisite Problem-Solving Resources.
  measure: Scale for the assessment of positive symptoms (SAPS) and negative symptoms (SANS)
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: Assessment of positive and negative symptomology
  measure: PHQ-9
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The Patient Health Questionnaire (PHQ-9) is a brief tool used to diagnose and measure severity of depression. The PHQ-9 is shorter than many of the other depression screening instruments and can be self-administered. Adapted from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), the PHQ-9 is comprised of the same diagnostic symptom criteria used in the DSM-IV:
  Two cardinal signs of depression (anhedonia and depressed mood); Cognitions (e.g. guilt/worthlessness and suicidality/thoughts of death); and Physical symptoms (e.g. change in appetite, difficulty sleeping and concentrating, feeling tired/slowed down or restless).
  measure: GAD-7
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks.
  measure: DUDIT
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The DUDIT is an 11-item self-administered screening instrument for drug-related problems, giving information on the level of drug intake and selected criteria for substance abuse/harmful use and dependence according to the ICD-10 and DSM-4 diagnostic systems.
  measure: AUDIT
  time frame: T0 (Baseline) T1 (1-2 weeks post intervention) T2 (3-month follow up)
  description: The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems.
  arm group label: Intervention
  arm group type: Experimental
  description: 15 sessions of the combined cognitive remediation training and social recovery therapy intervention.
  arm group label: Control
  arm group type: Active Comparator
  description: 15 sessions of social recovery therapy alone.
  intervention type: Behavioral
  intervention name: CRESTR Intervention
  description: 15 1-hour sessions of CRT + SRT
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: CRESTR Control
  description: 15 1-hour sessions of SRT alone
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Prof. Gary Donohoe
  phone: 0035391495122
  email: gary.donohoe@universityofgalway.ie
  last name: Dr Emma Frawley
  phone: 0035391495953
  email: emma.frawley@universityofgalway.ie
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Ireland
  citation: Frawley E, Cowman M, Cella M, Cohen D, Ryan E, Hallahan B, Bowie C, McDonald C, Fowler D, Wykes T, Donohoe G. Cognitive Remediation and Social Recovery in Early Psychosis (CReSt-R): protocol for a pilot randomised controlled study. Pilot Feasibility Stud. 2022 May 24;8(1):109. doi: 10.1186/s40814-022-01064-6.
  PMID: 35610711
  responsible party type: Principal Investigator
  investigator affiliation: National University of Ireland, Galway, Ireland
  investigator full name: Gary Donohoe
  investigator title: Professor Gary Donohoe
  mesh term: Psychotic Disorders
  mesh term: Mental Disorders
  sharing ipd: Yes
  ipd description: The full protocol in addition to datasets and statistical code generated during the current study will be available from the corresponding author on reasonable request.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd access criteria: The full protocol in addition to datasets and statistical code generated during the current study will be available from the corresponding author on reasonable request.