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

Primary Purpose

Mood Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cognitive remedy intervention with virtual reality (CEREBRUM)
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders focused on measuring Virtual Reality, Remediation, Mental Health, Recovery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

virtual reality

waiting list

Arm Description

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

waiting list

Outcomes

Primary Outcome Measures

Memory
Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale
Monitoring Side effects of Virtual Reality
Questionnaire (Qualitative)
Attention
Matrix Test Digit Symbol Substitution Test
Executive functions
Trial Making Test Verbal Phonological and Semantic Fluency Test Cognitive Estimation Test - CET Stroop Test Frontal Assessment Battery - FAB

Secondary Outcome Measures

Quality of Life
Short Form Healthy Survey Questionnaire - SF-12
Alexithymia
Toronto Alexithymia Scale - TAS-20
Anxiety
Self Anxiety Rating Scale - SAS
Depression
The Patient Health Questionnaire - PHQ-9
Biological Rythms
Biological Rythms Interview of Assesment in Neuropsychiatry - BRIAN
General and social functioning
Health of the Nation Outcome Scales - HoNOS

Full Information

First Posted
July 21, 2021
Last Updated
March 17, 2023
Sponsor
University of Cagliari
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1. Study Identification

Unique Protocol Identification Number
NCT05070065
Brief Title
Virtual Reality VAlidation Tool for Cognitive Rehabilitation, Oriented Project for People With Psychosocial Disabilieties
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders
Keywords
Virtual Reality, Remediation, Mental Health, Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled open-label cross-over clinical feasibility study with waiting list
Masking
Participant
Masking Description
people with psychosocial disabilities
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality
Arm Type
Experimental
Arm Description
The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM)
Arm Title
waiting list
Arm Type
Other
Arm Description
waiting list
Intervention Type
Device
Intervention Name(s)
Cognitive remedy intervention with virtual reality (CEREBRUM)
Intervention Description
Cognitive Remedial method Virtual Reality (CEREBRUM)
Primary Outcome Measure Information:
Title
Memory
Description
Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale
Time Frame
All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Title
Monitoring Side effects of Virtual Reality
Description
Questionnaire (Qualitative)
Time Frame
During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline)
Title
Attention
Description
Matrix Test Digit Symbol Substitution Test
Time Frame
All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Title
Executive functions
Description
Trial Making Test Verbal Phonological and Semantic Fluency Test Cognitive Estimation Test - CET Stroop Test Frontal Assessment Battery - FAB
Time Frame
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 Measure Information:
Title
Quality of Life
Description
Short Form Healthy Survey Questionnaire - SF-12
Time Frame
All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Title
Alexithymia
Description
Toronto Alexithymia Scale - TAS-20
Time Frame
All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Title
Anxiety
Description
Self Anxiety Rating Scale - SAS
Time Frame
All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Title
Depression
Description
The Patient Health Questionnaire - PHQ-9
Time Frame
All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Title
Biological Rythms
Description
Biological Rythms Interview of Assesment in Neuropsychiatry - BRIAN
Time Frame
All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Title
General and social functioning
Description
Health of the Nation Outcome Scales - HoNOS
Time Frame
All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
P.O. San Giovanni di Dio, AOU Cagliari
City
Cagliari
ZIP/Postal Code
09100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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