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

U

University of Cagliari

Status

Completed

Conditions

Mood Disorders

Treatments

Device: Cognitive remedy intervention with virtual reality (CEREBRUM)

Study type

Interventional

Funder types

Other

Identifiers

NCT05070065
Prot. PG/2020/7577

Details and patient eligibility

About

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.

Full 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

Enrollment

50 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

50 participants in 2 patient groups

virtual reality
Experimental group
Description:
The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM)
Treatment:
Device: Cognitive remedy intervention with virtual reality (CEREBRUM)
waiting list
Other group
Description:
waiting list
Treatment:
Device: Cognitive remedy intervention with virtual reality (CEREBRUM)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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