Verbal Memory Training Using Virtual Reality in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Verbal Memory Training Using Virtual Reality in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251195
• Other study ID #: 2018048
• Status: Completed
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: February 17, 2023

Study information

• Verified date: April 2023
• Source: The Royal Ottawa Mental Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	Royal Ottawa Mental Health Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Ottawa Mental Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, post treatment (~20 minutes)
Primary	Feasibility of the intervention	Feasibility of the intervention as measured by the number of people who complete the intervention.	baseline, post treatment (~20 minutes)
Secondary	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.	baseline, post treatment (~20 minutes)
Secondary	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.	post treatment (~20 minutes)
Secondary	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.	post treatment (~20 minutes)