Verbal Memory Training Using Virtual Reality in Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Intervention
Active Control Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Royal Ottawa Mental Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Intervention
Active Control Intervention
Arm Description
Outcomes
Primary Outcome Measures
Change in semantic encoding strategy use as measured by change in semantic clustering from baseline - the Hopkins Verbal Learning Test - Revisited (HVLT-R).
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
Feasibility of the intervention as measured by the number of people who complete the intervention.
Secondary Outcome Measures
Change in verbal memory performance from baseline
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
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)
Simulator sickness questionnaire (SSQ) is a 16-item questionnaire developed to examine the degree of cybersickness in participants after the use of VR.
Full Information
NCT ID
NCT04251195
First Posted
January 27, 2020
Last Updated
April 13, 2023
Sponsor
The Royal Ottawa Mental Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT04251195
Brief Title
Verbal Memory Training Using Virtual Reality in Schizophrenia
Official Title
Verbal Memory Training Using Virtual Reality in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Royal Ottawa Mental Health Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Intervention
Arm Type
Experimental
Arm Title
Active Control Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Intervention
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Active Control Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in semantic encoding strategy use as measured by change in semantic clustering from baseline - the Hopkins Verbal Learning Test - Revisited (HVLT-R).
Description
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.
Time Frame
baseline, post treatment (~20 minutes)
Title
Feasibility of the intervention
Description
Feasibility of the intervention as measured by the number of people who complete the intervention.
Time Frame
baseline, post treatment (~20 minutes)
Secondary Outcome Measure Information:
Title
Change in verbal memory performance from baseline
Description
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.
Time Frame
baseline, post treatment (~20 minutes)
Title
Participants' experience and tolerability - VR experience questionnaire
Description
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.
Time Frame
post treatment (~20 minutes)
Title
Participants' experience - Simulator sickness questionnaire (SSQ)
Description
Simulator sickness questionnaire (SSQ) is a 16-item questionnaire developed to examine the degree of cybersickness in participants after the use of VR.
Time Frame
post treatment (~20 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Synthia Guimond, PhD
Organizational Affiliation
Royal Ottawa Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Ottawa Mental Health Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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).
Citations:
PubMed Identifier
26145159
Citation
Guimond S, Lepage M. Cognitive training of self-initiation of semantic encoding strategies in schizophrenia: A pilot study. Neuropsychol Rehabil. 2016;26(3):464-79. doi: 10.1080/09602011.2015.1045526. Epub 2015 Jul 6.
Results Reference
result
PubMed Identifier
29102504
Citation
Guimond S, Beland S, Lepage M. Strategy for Semantic Association Memory (SESAME) training: Effects on brain functioning in schizophrenia. Psychiatry Res Neuroimaging. 2018 Jan 30;271:50-58. doi: 10.1016/j.pscychresns.2017.10.010. Epub 2017 Oct 25.
Results Reference
result
Learn more about this trial
Verbal Memory Training Using Virtual Reality in Schizophrenia
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