Clinical trial NCT04251195: Verbal Memory Training Using Virtual Reality in Schizophrenia
Official title: Verbal Memory Training Using Virtual Reality in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: The Royal Ottawa Mental Health Centre
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in semantic encoding strategy use as measured by change in semantic clustering from baseline - the Hopkins Verbal Learning Test - Revisited (HVLT-R).
timeFrame: baseline, post treatment (~20 minutes)
measure: Feasibility of the intervention
timeFrame: baseline, post treatment (~20 minutes)
Secondary outcomes:
measure: Change in verbal memory performance from baseline
timeFrame: baseline, post treatment (~20 minutes)
measure: Participants' experience and tolerability - VR experience questionnaire
timeFrame: post treatment (~20 minutes)
measure: Participants' experience - Simulator sickness questionnaire (SSQ)
timeFrame: post treatment (~20 minutes)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Royal Ottawa Mental Health Centre
state: Ontario
Study officials:
affiliation: Royal Ottawa Mental Health Center
name: Synthia Guimond, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.