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

NCT05070065 | Completed

• 1 other identifier: Prot. PG/2020/7577
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mood Disorders

Keywords

Virtual Reality; Remediation; Mental Health; Recovery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Quality of Life

  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

  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

  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

  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

  All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)

Study Arms (2)

virtual reality

EXPERIMENTAL

The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM)

Device: Cognitive remedy intervention with virtual reality (CEREBRUM)

waiting list

OTHER

waiting list

Device: Cognitive remedy intervention with virtual reality (CEREBRUM)

Interventions

Cognitive remedy intervention with virtual reality (CEREBRUM) DEVICE

Cognitive Remedial method Virtual Reality (CEREBRUM)

virtual reality; waiting list

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

P.O. San Giovanni di Dio, AOU Cagliari

Cagliari, 09100, Italy

Location

Related Publications (3)

• Sancassiani F, Perra A, Galetti A, Di Natale L, De Lorenzo V, Lorrai S, Kalcev G, Pintus E, Cantone E, Nonnis M, Nardi AE, Montisci R, Primavera D. Alexithymia and Bipolar Disorder: Virtual Reality Could Be a Useful Tool for the Treatment and Prevention of These Conditions in People with a Physical Comorbidity. J Clin Med. 2024 Oct 18;13(20):6206. doi: 10.3390/jcm13206206.

  PMID: 39458156 DERIVED

• Perra A, De Lorenzo V, Zaccheddu R, Locci A, Piludu F, Preti A, Di Natale L, Galetti A, Nardi AE, Cossu G, Sancassiani F, Barbato S, Cesaretti O, Kurotshka PK, Carta MG. Cognitive Remediation Virtual Reality Tool a Recovery-Oriented Project for People with Bipolar Disorder: Protocol of a Feasibility Randomized Clinical Trial. Clin Pract Epidemiol Ment Health. 2022 Oct 6;18:e174501792208220. doi: 10.2174/17450179-v18-e2208220. eCollection 2022.

  PMID: 37274852 DERIVED

• Perra A, Galetti A, Zaccheddu R, Locci A, Piludu F, Preti A, Primavera D, Di Natale L, Nardi AE, Kurotshka PK, Cossu G, Sancassiani F, Stella G, De Lorenzo V, Zreik T, Carta MG. A Recovery-Oriented Program for People with Bipolar Disorder through Virtual Reality-Based Cognitive Remediation: Results of a Feasibility Randomized Clinical Trial. J Clin Med. 2023 Mar 9;12(6):2142. doi: 10.3390/jcm12062142.

  PMID: 36983145 DERIVED

MeSH Terms

Conditions

Mood Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: people with psychosocial disabilities
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled open-label cross-over clinical feasibility study with waiting list

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: October 6, 2021
• Study Start: November 10, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)