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Completed

NCT Number: NCT05070065

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

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.

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Key information

Conditions

Mood Disorders Behavior Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

P.O. San Giovanni di Dio, AOU Cagliari

Cagliari, 09100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive remedy intervention with virtual reality (CEREBRUM)

Device

Cognitive Remedial method Virtual Reality (CEREBRUM)

Primary outcomes

  1. Memory

    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)

    Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale

  2. Monitoring Side effects of Virtual Reality

    Time frame: During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline)

    Questionnaire (Qualitative)

  3. Attention

    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)

    Matrix Test Digit Symbol Substitution Test

  4. Executive functions

    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)

    Trial Making Test Verbal Phonological and Semantic Fluency Test Cognitive Estimation Test - CET Stroop Test Frontal Assessment Battery - FAB

Secondary outcomes

  1. Quality of Life

    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)

    Short Form Healthy Survey Questionnaire - SF-12

  2. Alexithymia

    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)

    Toronto Alexithymia Scale - TAS-20

  3. Anxiety

    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)

    Self Anxiety Rating Scale - SAS

  4. Depression

    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)

    The Patient Health Questionnaire - PHQ-9

  5. Biological Rythms

    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)

    Biological Rythms Interview of Assesment in Neuropsychiatry - BRIAN

  6. General and social functioning

    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)

    Health of the Nation Outcome Scales - HoNOS

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2021
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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