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

Mood Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05070065
• Other study ID #: Prot. PG/2020/7577
• Status: Completed
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: March 2023
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders

Intervention

Device:
• Cognitive remedy intervention with virtual reality (CEREBRUM)
Cognitive Remedial method Virtual Reality (CEREBRUM)

Locations

Country	Name	City	State
Italy	P.O. San Giovanni di Dio, AOU Cagliari	Cagliari

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)