Virtual Reality VAlidation Tool for Cognitive Rehabilitation, Oriented Project for People With Psychosocial Disabilieties

VIVA-CORE! Virtual Reality VAlidation Tool for Cognitive Rehabilitation, a REcovery Oriented Project for People With Psychosocial Disabilieties: Protocol of Randomize Clinical Trial

Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a VR intervention of 3 months with 2 weekly session of CEREBRUM (cognitive remedy intervention with virtual reality) first to the group A and then to the group B.

Study Overview

• Status: Completed
• Conditions: Mood Disorders
• Intervention / Treatment: Device: Cognitive remedy intervention with virtual reality (CEREBRUM)

Detailed Description

Background: Cognitive remedial interventions have been found to be effective in the treatment of various psycho-social disorders. The use of Virtual reality as a rehabilitation tool has been showing various scientific evidences in recent years like in cardiovascular, neurological and musculoskeletal rehabilitation. In mental health evidence they seem to be concentrated in the rehabilitation of social cognition in people with schizophrenia diagnosis and psychotherapy. The aim of this study is to evaluate the feasibility and the effectiveness of the first Cognitive Remedial toll in Virtual Reality (CEREBRUM) for people that has experienced in mental health.

Methods: Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a intervention of 3 months with 2 weekly session of CEREBRUM first to the group A and then to the group B

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandra Perra, Phd student; Phone Number: +393481444501; Email: alessandra.perra93@gmail.com

Study Locations

• Italy
  • Cagliari, Italy, 09100
    • P.O. San Giovanni di Dio, AOU Cagliari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age from 18 to 75;
• Diagnosis of psychosis and / or mood disorder according to DSM-IV (American Psychiatric Association, 2000).
• both sexes;
• users who sign the informed consent;
• users under protection for which the informed consent is signed by the guardian

Exclusion Criteria:

• The non-satisfaction of the inclusion criteria;
• The diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality; The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM)	Device: Cognitive remedy intervention with virtual reality (CEREBRUM); Cognitive Remedial method Virtual Reality (CEREBRUM)
Other: waiting list	Device: Cognitive remedy intervention with virtual reality (CEREBRUM); Cognitive Remedial method Virtual Reality (CEREBRUM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory	Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Monitoring Side effects of Virtual Reality	Questionnaire (Qualitative)	During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline)
Attention	Matrix Test Digit Symbol Substitution Test	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Executive functions	Trial Making Test Verbal Phonological and Semantic Fluency Test Cognitive Estimation Test - CET Stroop Test Frontal Assessment Battery - FAB	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Short Form Healthy Survey Questionnaire - SF-12	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Alexithymia	Toronto Alexithymia Scale - TAS-20	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Anxiety	Self Anxiety Rating Scale - SAS	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Depression	The Patient Health Questionnaire - PHQ-9	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Biological Rythms	Biological Rythms Interview of Assesment in Neuropsychiatry - BRIAN	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
General and social functioning	Health of the Nation Outcome Scales - HoNOS	All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)

Collaborators and Investigators

• Sponsor: University of Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Mental Health; Recovery; Virtual Reality; Remediation
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: Prot. PG/2020/7577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No