Verbal Memory Training Using Virtual Reality in Schizophrenia

NCT04251195 | Completed

• 1 other identifier: 2018048
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• Change in verbal memory performance from baseline

  baseline, post treatment (~20 minutes)

• Participants' experience and tolerability - VR experience questionnaire

  post treatment (~20 minutes)

• Participants' experience - Simulator sickness questionnaire (SSQ)

  post treatment (~20 minutes)

Study Arms (2)

Cognitive Intervention

EXPERIMENTAL

Behavioral: Cognitive Intervention

Active Control Intervention

ACTIVE COMPARATOR

Behavioral: Active Control Intervention

Interventions

Cognitive Intervention BEHAVIORAL

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).

Cognitive Intervention

Active Control Intervention BEHAVIORAL

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

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Ottawa Mental Health Centre: lead

Study Sites (1)

Royal Ottawa Mental Health Centre

Ottawa, Ontario, K1Z 7K4, Canada

Location

Related Publications (2)

• 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.

  PMID: 26145159 RESULT

• 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.

  PMID: 29102504 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Synthia Guimond, PhD

  Royal Ottawa Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 31, 2020
• Study Start: February 12, 2019
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, 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).

Locations

CA (1)