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Verbal Memory Training Using Virtual Reality in Schizophrenia

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ClinicalTrials.gov Identifier: NCT04251195
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Synthia Guimond, The Royal Ottawa Mental Health Centre

Tracking Information
First Submitted Date  ICMJE January 27, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date October 6, 2020
Actual Study Start Date  ICMJE February 12, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • Change in semantic encoding strategy use as measured by change in semantic clustering from baseline - the Hopkins Verbal Learning Test - Revisited (HVLT-R). [ Time Frame: baseline, post treatment (~20 minutes) ]
    The Hopkins Verbal Learning Test - Revisited (HVLT-R) for verbal memory is a 12-item test to measure a person's ability to encode, combine, store and recover verbal information in memory.
  • Feasibility of the intervention [ Time Frame: baseline, post treatment (~20 minutes) ]
    Feasibility of the intervention as measured by the number of people who complete the intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • Change in verbal memory performance from baseline [ Time Frame: baseline, post treatment (~20 minutes) ]
    The Hopkins Verbal Learning Test - Revisited (HVLT-R) for verbal memory is a 12-item test to measure a person's ability to encode, combine, store and recover verbal information in memory.
  • Participants' experience and tolerability - VR experience questionnaire [ Time Frame: post treatment (~20 minutes) ]
    VR experience questionnaire is a 5-item questionnaire that our research team designed to obtain feedback from participants regarding their experience with the VR intervention following the completion of the VR session.
  • Participants' experience - Simulator sickness questionnaire (SSQ) [ Time Frame: post treatment (~20 minutes) ]
    Simulator sickness questionnaire (SSQ) is a 16-item questionnaire developed to examine the degree of cybersickness in participants after the use of VR.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Verbal Memory Training Using Virtual Reality in Schizophrenia
Official Title  ICMJE Verbal Memory Training Using Virtual Reality in Schizophrenia
Brief Summary Verbal episodic memory is an independent declarative memory system associated with language and is responsible for storage and conscious recall of previous personal experiences. Verbal episodic memory is impaired in schizophrenia and is related to patients' functional outcomes. Because no medication has shown clear positive effects on verbal memory impairment in schizophrenia, there is a great need to find effective cognitive remediation treatments (CRT) that could improve this domain in this psychiatric population. Although CRT programs have shown small to moderate positive effects on verbal memory in individuals with schizophrenia, traditional lab-based computerised cognitive interventions have notable attrition rates. In recent years, along with the advancement of technology, the development of Virtual Reality (VR) has allowed the possibility for new training techniques. Previous studies have established the initial feasibility and safety of using VR in schizophrenia population. However, no studies have examined the feasibility, safety and efficacy of combining VR technology with verbal memory training among individuals with schizophrenia. Thus, in this study, we will adapt an exercise from the Strategy for Semantic Association Memory (SESAME; (Guimond et al., 2018; Guimond & Lepage, 2016) training to a VR environment. We aim to determine the feasibility of using virtual reality in the context of a cognitive remediation intervention and to assess the initial efficacy of our verbal memory training on the use of semantic encoding strategies in people with schizophrenia. We also aim to assess participants' experience and tolerability of the VR training.
Detailed Description In this study, participants will first undergo the Hopkins Verbal Learning Test - Revisited (HVLT-R) to assess the baseline use of semantic clustering and verbal memory recall performance. Participants will then be randomly assigned to either a control group or a verbal training group. Participants in both groups will undergo a short session (15 minutes) of VR training. Finally, participants will be invited to perform an alternate version of the HVLT-R to assess initial change in semantic clustering and verbal memory recall performance after the training. They will also complete the VR Experience Questionnaire and the simulator sickness questionnaire (SSQ) in order for the research team to gain feedback from participants regarding their experience and tolerability of the VR session.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE
  • Behavioral: Cognitive Intervention
    Participants will undergo 15 minutes of a cognitively challenging activity in the Virtual Reality environment. (More details about each condition will be added after study completion to protect the blinding of our participants).
  • Behavioral: Active Control Intervention
    Participants will undergo 15 minutes of a cognitively challenging activity in the Virtual Reality environment. (More details about each condition will be added after study completion to protect the blinding of our participants).
Study Arms  ICMJE
  • Experimental: Cognitive Intervention
    Intervention: Behavioral: Cognitive Intervention
  • Active Comparator: Active Control Intervention
    Intervention: Behavioral: Active Control Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 20-60 years
  • the ability to read and speak fluent English
  • having a diagnosis of schizophrenia or schizoaffective from a psychiatrist and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) interview
  • considered clinically stable (on stable medication for more than one month, and have a score below 95 on the Positive and Negative Syndrome Scale (PANSS))

Exclusion Criteria:

  • having vision problems that cannot be corrected with contact lenses or glasses that fit into the VR goggles (because of requirements of VR headset)
  • having significant neurological or medical disorders (other than schizophrenia/schizoaffective disorder) that may produce cognitive impairment
  • a recent history of substance abuse or dependence (within the past 3 months)
  • decisional incapacity requiring a guardian
  • having past or current conditions of seizure, epilepsy, migraines or cybersickness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Synthia Guimond, PhD 6137226521 ext 6586 Synthia.Guimond@theroyal.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251195
Other Study ID Numbers  ICMJE 2018048
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the general public upon request. Data that can connect with participants' identity will NOT be used or shared for analyses.
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: De-identified data will become available upon completion of the study and once results have been published in an academic journal (anticipated time frame: the year of 2021).
Responsible Party Synthia Guimond, The Royal Ottawa Mental Health Centre
Study Sponsor  ICMJE The Royal Ottawa Mental Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Synthia Guimond, PhD Royal Ottawa Mental Health Center
PRS Account The Royal Ottawa Mental Health Centre
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP