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/NCT06038955</url>
    </required_header>
    <id_info>
      <org_study_id>H-22004153</org_study_id>
      <secondary_id>P-2022-411</secondary_id>
      <nct_id>NCT06038955</nct_id>
    </id_info>
    <brief_title>Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood - or Psychosis Spectrum Disorders</brief_title>
    <official_title>Effect of Immersive Virtual Reality-based Cognitive Remediation in Patients With Mood Disorders or Psychosis Spectrum Disorders: a Randomized, Controlled, Double-blinded Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mental Health Services in the Capital Region, Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>TrygFonden, Denmark</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Copenhagen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Rigshospitalet, Denmark</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mental Health Services in the Capital Region, Denmark</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this clinical trial is to investigate the effect of a four-weeks, intensive&#xD;
        virtual reality-based cognitive remediation (training) programme involving simulated&#xD;
        daily-life challenges on cognition and functional capacity in symptomatically stable patients&#xD;
        with mood disorders (depression or bipolar disorder) or psychosis spectrum disorders&#xD;
        (F20-F29; e.g. schizophrenia or schizotypal disorder).&#xD;
  &#xD;
        We hypothesize that VR-based cognitive remediation vs. a VR control treatment has a&#xD;
        beneficial effect on cognition after four-weeks treatment completion (primary outcome&#xD;
        assessement time) measured with a novel ecologically valid VR test of daily-life cognitive&#xD;
        functions (The CAVIR test; primary outcome measure), a verbal learning and memory composite&#xD;
        score based on a traditional neuropsychological test and a performance-based measure of daily&#xD;
        functioning (secondary outcome measures). Finally, for exploratory purposes, we will examine&#xD;
        neuronal underpinnings of treatment effects, and effects on additional measures of cognition,&#xD;
        functioning and self-ratings scales (tertiary outcomes).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The current study will include outpatients with a mood disorders (unipolar - or bipolar&#xD;
        disorder) in full or partial remission at the time of inclusion (score ≤ 14 on the Hamilton&#xD;
        Depression or a psychosis spectrum disorders (F20-F29) that have been assessed to be&#xD;
        relatively symptom stable by their treating clinician upon referral to the study. To&#xD;
        accommodate for an approximately 15% drop-out rate from baseline to treatment completion (the&#xD;
        primary outcome assessement time point), we will recruit up to 100 participants (50&#xD;
        participants per intervention arm) to obtain complete data for minimum 86 participants (43&#xD;
        participants per arm).&#xD;
  &#xD;
        Recruitment will be carried out through the outpatient Copenhagen Affective Disorder Clinic,&#xD;
        the outpatient, early intervention clinics for psychotic disorders (OPUS), other mental&#xD;
        health centres in the Capital Region of Denmark, and through advertisements on relevant&#xD;
        websites.&#xD;
  &#xD;
        After inclusion, the baseline assessements are scheduled and completed over two days, one to&#xD;
        five days apart. On day 1, the participant is assessed with the virtual cognition test (the&#xD;
        CAVIR test) and a comprehensive neuropsychological test battery. Participants also complete&#xD;
        questionnaires concerning subjective cognitive complaints, quality of life and general&#xD;
        acceptance of virtual reality technology. Functional capacity is assessed using a&#xD;
        clinician-rated interview and a performance-based assessment. For participants with mood&#xD;
        disorders, mood symptoms are rated with the HDRS-17 and YMRS. For participants with psychosis&#xD;
        spectrum disorders, positive and negative symptoms are rated with the SAPS and BNSS,&#xD;
        respectively. Finally, sleep quantity and quality in the past 3 days is recorded. Later the&#xD;
        same day an fMRI scan is carried out encompassing a spatial working memory N-back task, a&#xD;
        word encoding paradigm in which participants must encode and subsequently recognize words of&#xD;
        typical household items, a resting state, and a structural scan. On day 2, participants'&#xD;
        daily life functional capacity is assessed with The Assessement of Motor and Process Skills&#xD;
        (AMPS) by an AMPS-certified occupational therapist in a standardized test kitchen.&#xD;
  &#xD;
        The virtual reality cognition test, neuropsychological assessments, questionnaires, clinical&#xD;
        symptom ratings, assessements of functional capacity (including AMPS) and fMRI scan are&#xD;
        repeated within 2 weeks of treatment completion (primary outcome assessement time). All&#xD;
        assessments except for the fMRI scan are repeated again 3 months after treatment completion&#xD;
        to assess durability.&#xD;
  &#xD;
        Participants are randomized upon full completion of the baseline assessement with allocation&#xD;
        being carried out using the automated randomization module in the online Research Electronic&#xD;
        Data Capture (REDcap) system based on an uploaded blocked randomization list stratified by&#xD;
        age (&lt; or ≥ 35 years) and diagnosis (mood disorders v. psychosis spectrum disorder)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 1, 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>
      <intervention_model_description>Randomized, controlled, double-blinded, parallel-group design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The study has a double-blinded design. Neither the participant nor the outcome-assessors will know whether the participant is receiving VR-based cognitive remediation or VR control treatment</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cognition Assessement in Virtual Reality (CAVIR) test: cognitive composite score</measure>
      <time_frame>Baseline, treatment completion (primary outcome assessement time point) and 3-months follow-up</time_frame>
      <description>The primary outcome measure is a broad cognitive composite score spanning all five subtasks on a novel virtual reality test of daily-life cognitive functions, the Cognition Assessement in Virtual Reality (CAVIR) test (for more details, see Miskowiak et al. 2022 under references). The CAVIR test is a self-administered 360º immersive VR test in a kitchen, where the participant's abilities to plan and prepare a meal are assessed. The test has a duration of 15 minutes and involves five subtasks probing verbal memory, executive functions, processing speed, working memory and sustained attention, respectively. The cognitive composite score is calculated by averaging the z-transformed scores on the five CAVIR subtasks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rey Auditory Verbal Learning Test (RAVLT): verbal learning and memory domain composite score</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>A domain composite of 'verbal learning and memory' comprising the following subtests on the Rays Verbal Learning (RAVLT) Test: RAVLT total recall lists I-V, RAVLT immediate recall, RAVLT delayed recall</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessement of Motor and Process skills (AMPS)</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>A recommended measure of functional capacity (i.e. Activity of Daily Living) in individuals with psychiatric illness and cognitive impairment conducted by an AMPS-certificated occupational therapist a standardized test apartement.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>One Touch Stocking of Cambridge</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>A computerised neuropsychological test assessing executive function</description>
    </other_outcome>
    <other_outcome>
      <measure>Spatial Working Memory test</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>A computerised neuropsychological test assessing spatial working memory</description>
    </other_outcome>
    <other_outcome>
      <measure>Rapid Visual Information Processing</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>A computerised neuropsychological test assessing sustained attention</description>
    </other_outcome>
    <other_outcome>
      <measure>WAIS-III letter-number sequencing</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Neuropsychological test assessing executive function</description>
    </other_outcome>
    <other_outcome>
      <measure>Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) Digit Span</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Neuropsychological test assessing attention</description>
    </other_outcome>
    <other_outcome>
      <measure>Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) Coding</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Neuropsychological test assessing processing speed</description>
    </other_outcome>
    <other_outcome>
      <measure>Verbal Fluency with the letter &quot;D&quot; and &quot;S&quot;</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Neuropsychological test assessing executive function</description>
    </other_outcome>
    <other_outcome>
      <measure>Trail Making Test A</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Neuropsychological test assessing attention</description>
    </other_outcome>
    <other_outcome>
      <measure>Trail Making Test B</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Neuropsychological test assessing executive function</description>
    </other_outcome>
    <other_outcome>
      <measure>Brief University of California, San Diego Performance-Based Skills Assessment-B (UPSA-B)</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Objective assessment of level of functioning</description>
    </other_outcome>
    <other_outcome>
      <measure>Wisconsin Card Sorting Task</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Computerized neuropsychological test assessing executive function</description>
    </other_outcome>
    <other_outcome>
      <measure>Functional Assessment Short Test</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Observer-based rating of level of functioning</description>
    </other_outcome>
    <other_outcome>
      <measure>Cognitive Complaints in Bipolar Disorder Rating Assessement (COBRA)</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Questionnaire on subjective cognitive complaints</description>
    </other_outcome>
    <other_outcome>
      <measure>World Health Organization Quality of Life (WHOQOL-BREF)</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Questionnaire on quality of life</description>
    </other_outcome>
    <other_outcome>
      <measure>Cognitive Difficulties in Everyday Life (CODEL)</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Questionnaire on subjective cognitive complaints</description>
    </other_outcome>
    <other_outcome>
      <measure>Percieved Competence Scale (PCS)</measure>
      <time_frame>Baseline, treatment completion and 3-months follow-up</time_frame>
      <description>Questionnaire on self-efficacy</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Bipolar Disorder</condition>
    <condition>Depression</condition>
    <condition>Psychotic Disorders</condition>
    <condition>Cognitive Impairment</condition>
    <condition>Schizophrenia</condition>
    <condition>Schizotypal Disorder</condition>
    <arm_group>
      <arm_group_label>Virtual reality Based Cognitive Remediation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The cognitive remediation program has a duration of four weeks and involves two weekly 1,5-hour virtual reality-based cognitive training sessions with a therapist accompanied by additional between-session virtual reality training at home and homework assignments consisting of cognitively challenging daily life tasks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Virtual reality control treatment</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>The control treatment program also has a duration of four weeks and involves one weekly 2-hour session with a therapist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Virtual reality Based Cognitive Remediation</intervention_name>
      <description>The main component of the intervention is a virtual reality training platform in 360° Oculus Quest 2-software in which participants train their cognitive abilities guided by the therapist. The platform includes four immersive daily-life scenarios in which patients have consistently reported that they often experience cognitive difficulties: (1) a kitchen scenario focusing on planning and cooking a meal, (2) a supermarket scenario focusing on grocery shopping, (3) a restaurant scenario focusing on remembering names and personal information and (4) an office scenario focusing on planning, initiating, and completing work assignments. The virtual reality training is supported by a psychoeducation program that focuses on application of learned cognitive strategies in daily life.</description>
      <arm_group_label>Virtual reality Based Cognitive Remediation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Virtual reality control training</intervention_name>
      <description>The virtual reality control training involves completing different virtual reality games that are available through the Oculus Quest games store.The chosen games involve no direct training of cognitive abilities such as planning skills og strategic learning, but merely involves simple reaction time and interaction with an entertaining environment that is meaningful to the participant and gives the impression of training cognitive skills.</description>
      <arm_group_label>Virtual reality control treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Fluent Danish skills&#xD;
  &#xD;
            -  Meet the ICD-10 diagnosis of unipolar disorder, bipolar disorder (types I and II) or a&#xD;
               psychosis spectrum disorder (i.e. F20-F29) confirmed using the Schedules for Clinical&#xD;
               Assessment in Neuropsychiatry (SCAN) interview&#xD;
  &#xD;
            -  Patients must have objective and subjective cognitive impairment at the time of&#xD;
               inclusion. Objective cognitive impairment is defined a total score on the Screen for&#xD;
               Cognitive Impairment in Psychiatry - Danish version (SCIP-D) ≥ 0.5 standard deviations&#xD;
               (SD) below the expected total score based on age, education, and gender or as a score&#xD;
               ≥ 0.5 SD below the expected score on a minimum of two out of the five subtests (verbal&#xD;
               learning test - immediate, working memory test, verbal fluency test, verbal learning,&#xD;
               test - delayed, and processing speed test). Subjective cognitive impairment is defined&#xD;
               as a score ≥ 14 on the Cognitive Complaints in Bipolar Disorder Rating Scale (COBRA).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current drug or substance abuse&#xD;
  &#xD;
            -  A daily use of benzodiazepines &gt;22.5 mg oxazepam or &gt;7.5 mg diazepam (cutoffs for&#xD;
               doses with limited cognitive side effects)&#xD;
  &#xD;
            -  Comorbid neurological disorder&#xD;
  &#xD;
            -  Previous serious head trauma&#xD;
  &#xD;
            -  Dyslexia&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Claustrophobia (fMRI scan)&#xD;
  &#xD;
            -  Having a pacemaker or other metal implants inside the body (fMRI scan)&#xD;
  &#xD;
            -  Having had electroconvulsive therapy in the 3 months prior to inclusion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kamilla Woznica Miskowiak, DMSc, DPhil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mental Health Services in the Capital Region, Denmark</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andreas Elleby Jespersen, PhD-student</last_name>
      <phone>+4528587815</phone>
      <email>andreas.elleby.jespersen@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kamilla Woznica Miskowiak, DMSc, DPhil</last_name>
      <phone>+4522771617</phone>
      <email>kamilla.woznica.miskowiak@regionh.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Neurocognition and Emotion in Affective Disorders (NEAD) Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg hospital</name>
        <address>
          <city>Frederiksberg</city>
          <state>Capital Region Of Copenhagen</state>
          <zip>2000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <reference>
      <citation>Miskowiak KW, Jespersen AE, Kessing LV, Aggestrup AS, Glenthoj LB, Nordentoft M, Ott CV, Lumbye A. Cognition Assessment in Virtual Reality: Validity and feasibility of a novel virtual reality test for real-life cognitive functions in mood disorders and psychosis spectrum disorders. J Psychiatr Res. 2021 Dec 12;145:182-189. doi: 10.1016/j.jpsychires.2021.12.002. Online ahead of print.</citation>
      <PMID>34923359</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 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 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mental Health Services in the Capital Region, Denmark</investigator_affiliation>
      <investigator_full_name>Kamilla Woznica Miskowiak</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Cognition</keyword>
    <keyword>Cognitive Impairment</keyword>
    <keyword>Cognitive Remediation</keyword>
    <keyword>Depression</keyword>
    <keyword>Bipolar Disorder</keyword>
    <keyword>Schizophrenia</keyword>
    <keyword>Schizotypal Disorder</keyword>
    <keyword>Psychotic Disorders</keyword>
    <keyword>Virtual Reality</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
      <mesh_term>Bipolar Disorder</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Mental Disorders</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/NCT06038955
  org study id: H-22004153
  secondary id: P-2022-411
  nct id: NCT06038955
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate the effect of a four-weeks, intensive
        virtual reality-based cognitive remediation (training) programme involving simulated
        daily-life challenges on cognition and functional capacity in symptomatically stable patients
        with mood disorders (depression or bipolar disorder) or psychosis spectrum disorders
        (F20-F29; e.g. schizophrenia or schizotypal disorder).
  
        We hypothesize that VR-based cognitive remediation vs. a VR control treatment has a
        beneficial effect on cognition after four-weeks treatment completion (primary outcome
        assessement time) measured with a novel ecologically valid VR test of daily-life cognitive
        functions (The CAVIR test; primary outcome measure), a verbal learning and memory composite
        score based on a traditional neuropsychological test and a performance-based measure of daily
        functioning (secondary outcome measures). Finally, for exploratory purposes, we will examine
        neuronal underpinnings of treatment effects, and effects on additional measures of cognition,
        functioning and self-ratings scales (tertiary outcomes).
  The current study will include outpatients with a mood disorders (unipolar - or bipolar
        disorder) in full or partial remission at the time of inclusion (score ≤ 14 on the Hamilton
        Depression or a psychosis spectrum disorders (F20-F29) that have been assessed to be
        relatively symptom stable by their treating clinician upon referral to the study. To
        accommodate for an approximately 15% drop-out rate from baseline to treatment completion (the
        primary outcome assessement time point), we will recruit up to 100 participants (50
        participants per intervention arm) to obtain complete data for minimum 86 participants (43
        participants per arm).
  
        Recruitment will be carried out through the outpatient Copenhagen Affective Disorder Clinic,
        the outpatient, early intervention clinics for psychotic disorders (OPUS), other mental
        health centres in the Capital Region of Denmark, and through advertisements on relevant
        websites.
  
        After inclusion, the baseline assessements are scheduled and completed over two days, one to
        five days apart. On day 1, the participant is assessed with the virtual cognition test (the
        CAVIR test) and a comprehensive neuropsychological test battery. Participants also complete
        questionnaires concerning subjective cognitive complaints, quality of life and general
        acceptance of virtual reality technology. Functional capacity is assessed using a
        clinician-rated interview and a performance-based assessment. For participants with mood
        disorders, mood symptoms are rated with the HDRS-17 and YMRS. For participants with psychosis
        spectrum disorders, positive and negative symptoms are rated with the SAPS and BNSS,
        respectively. Finally, sleep quantity and quality in the past 3 days is recorded. Later the
        same day an fMRI scan is carried out encompassing a spatial working memory N-back task, a
        word encoding paradigm in which participants must encode and subsequently recognize words of
        typical household items, a resting state, and a structural scan. On day 2, participants'
        daily life functional capacity is assessed with The Assessement of Motor and Process Skills
        (AMPS) by an AMPS-certified occupational therapist in a standardized test kitchen.
  
        The virtual reality cognition test, neuropsychological assessments, questionnaires, clinical
        symptom ratings, assessements of functional capacity (including AMPS) and fMRI scan are
        repeated within 2 weeks of treatment completion (primary outcome assessement time). All
        assessments except for the fMRI scan are repeated again 3 months after treatment completion
        to assess durability.
  
        Participants are randomized upon full completion of the baseline assessement with allocation
        being carried out using the automated randomization module in the online Research Electronic
        Data Capture (REDcap) system based on an uploaded blocked randomization list stratified by
        age (< or ≥ 35 years) and diagnosis (mood disorders v. psychosis spectrum disorder)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized, controlled, double-blinded, parallel-group design
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The study has a double-blinded design. Neither the participant nor the outcome-assessors will know whether the participant is receiving VR-based cognitive remediation or VR control treatment
  measure: Cognition Assessement in Virtual Reality (CAVIR) test: cognitive composite score
  time frame: Baseline, treatment completion (primary outcome assessement time point) and 3-months follow-up
  description: The primary outcome measure is a broad cognitive composite score spanning all five subtasks on a novel virtual reality test of daily-life cognitive functions, the Cognition Assessement in Virtual Reality (CAVIR) test (for more details, see Miskowiak et al. 2022 under references). The CAVIR test is a self-administered 360º immersive VR test in a kitchen, where the participant's abilities to plan and prepare a meal are assessed. The test has a duration of 15 minutes and involves five subtasks probing verbal memory, executive functions, processing speed, working memory and sustained attention, respectively. The cognitive composite score is calculated by averaging the z-transformed scores on the five CAVIR subtasks.
  measure: Rey Auditory Verbal Learning Test (RAVLT): verbal learning and memory domain composite score
  time frame: Baseline, treatment completion and 3-months follow-up
  description: A domain composite of 'verbal learning and memory' comprising the following subtests on the Rays Verbal Learning (RAVLT) Test: RAVLT total recall lists I-V, RAVLT immediate recall, RAVLT delayed recall
  measure: Assessement of Motor and Process skills (AMPS)
  time frame: Baseline, treatment completion and 3-months follow-up
  description: A recommended measure of functional capacity (i.e. Activity of Daily Living) in individuals with psychiatric illness and cognitive impairment conducted by an AMPS-certificated occupational therapist a standardized test apartement.
  measure: One Touch Stocking of Cambridge
  time frame: Baseline, treatment completion and 3-months follow-up
  description: A computerised neuropsychological test assessing executive function
  measure: Spatial Working Memory test
  time frame: Baseline, treatment completion and 3-months follow-up
  description: A computerised neuropsychological test assessing spatial working memory
  measure: Rapid Visual Information Processing
  time frame: Baseline, treatment completion and 3-months follow-up
  description: A computerised neuropsychological test assessing sustained attention
  measure: WAIS-III letter-number sequencing
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Neuropsychological test assessing executive function
  measure: Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) Digit Span
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Neuropsychological test assessing attention
  measure: Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) Coding
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Neuropsychological test assessing processing speed
  measure: Verbal Fluency with the letter "D" and "S"
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Neuropsychological test assessing executive function
  measure: Trail Making Test A
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Neuropsychological test assessing attention
  measure: Trail Making Test B
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Neuropsychological test assessing executive function
  measure: Brief University of California, San Diego Performance-Based Skills Assessment-B (UPSA-B)
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Objective assessment of level of functioning
  measure: Wisconsin Card Sorting Task
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Computerized neuropsychological test assessing executive function
  measure: Functional Assessment Short Test
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Observer-based rating of level of functioning
  measure: Cognitive Complaints in Bipolar Disorder Rating Assessement (COBRA)
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Questionnaire on subjective cognitive complaints
  measure: World Health Organization Quality of Life (WHOQOL-BREF)
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Questionnaire on quality of life
  measure: Cognitive Difficulties in Everyday Life (CODEL)
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Questionnaire on subjective cognitive complaints
  measure: Percieved Competence Scale (PCS)
  time frame: Baseline, treatment completion and 3-months follow-up
  description: Questionnaire on self-efficacy
  arm group label: Virtual reality Based Cognitive Remediation
  arm group type: Experimental
  description: The cognitive remediation program has a duration of four weeks and involves two weekly 1,5-hour virtual reality-based cognitive training sessions with a therapist accompanied by additional between-session virtual reality training at home and homework assignments consisting of cognitively challenging daily life tasks.
  arm group label: Virtual reality control treatment
  arm group type: Sham Comparator
  description: The control treatment program also has a duration of four weeks and involves one weekly 2-hour session with a therapist.
  intervention type: Behavioral
  intervention name: Virtual reality Based Cognitive Remediation
  description: The main component of the intervention is a virtual reality training platform in 360° Oculus Quest 2-software in which participants train their cognitive abilities guided by the therapist. The platform includes four immersive daily-life scenarios in which patients have consistently reported that they often experience cognitive difficulties: (1) a kitchen scenario focusing on planning and cooking a meal, (2) a supermarket scenario focusing on grocery shopping, (3) a restaurant scenario focusing on remembering names and personal information and (4) an office scenario focusing on planning, initiating, and completing work assignments. The virtual reality training is supported by a psychoeducation program that focuses on application of learned cognitive strategies in daily life.
  arm group label: Virtual reality Based Cognitive Remediation
  intervention type: Behavioral
  intervention name: Virtual reality control training
  description: The virtual reality control training involves completing different virtual reality games that are available through the Oculus Quest games store.The chosen games involve no direct training of cognitive abilities such as planning skills og strategic learning, but merely involves simple reaction time and interaction with an entertaining environment that is meaningful to the participant and gives the impression of training cognitive skills.
  arm group label: Virtual reality control treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Kamilla Woznica Miskowiak, DMSc, DPhil
  role: Principal Investigator
  affiliation: Mental Health Services in the Capital Region, Denmark
  last name: Andreas Elleby Jespersen, PhD-student
  phone: +4528587815
  email: andreas.elleby.jespersen@regionh.dk
  last name: Kamilla Woznica Miskowiak, DMSc, DPhil
  phone: +4522771617
  email: kamilla.woznica.miskowiak@regionh.dk
  facility: 
  status: Recruiting
  country: Denmark
  citation: Miskowiak KW, Jespersen AE, Kessing LV, Aggestrup AS, Glenthoj LB, Nordentoft M, Ott CV, Lumbye A. Cognition Assessment in Virtual Reality: Validity and feasibility of a novel virtual reality test for real-life cognitive functions in mood disorders and psychosis spectrum disorders. J Psychiatr Res. 2021 Dec 12;145:182-189. doi: 10.1016/j.jpsychires.2021.12.002. Online ahead of print.
  PMID: 34923359
  responsible party type: Principal Investigator
  investigator affiliation: Mental Health Services in the Capital Region, Denmark
  investigator full name: Kamilla Woznica Miskowiak
  investigator title: Professor
  mesh term: Depression
  mesh term: Schizophrenia
  mesh term: Cognitive Dysfunction
  mesh term: Bipolar Disorder
  mesh term: Psychotic Disorders
  mesh term: Mental Disorders
  sharing ipd: No