Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia

Официальное название

Effect of Virtual Reality-based Therapy on Negative Symptoms in People with Schizophrenia: Study Protocol for a Randomized Controlled Trial

Обзор

A randomised, controlled, double-blind clinical trial will be carried out to evaluate the effectiveness of a VR assisted treatment for negative symptoms in people with schizophrenia. Patients with a standardised diagnosis of schizophrenia meeting the inclusion criteria will receive 12 weekly sessions of VR assisted therapy plus treatment as usual (TAU). A control group will be exposed to a neutral VR environment plus TAU. The hypothesis is that patients who are treated with active VR assisted therapy will have less negative symptoms as rated by the PANSS-N scale, compared to the control group. The protocol was approved by the hospital ethics committee of the Servicio de Salud Metropolitano Suroriente. Patients sign an informed consent form, from which they may withdraw at any point during the intervention.

Вмешательства

• Поведенческое Virtual Reality Therapy for the Negative Symptoms of Schizophrenia
  VRTNSS is a 12-session therapy using psychological intervention principles. Each therapy session will involve engaging with different VR based tasks where participants can experience different activities.
• Поведенческое Sham- VR
  Patients will attend to VR sessions without the software created activities for treatment (sham-VR).

Первичные конечные точки

• Negative symptoms [Срок оценки: 12 weeks]

Вторичные конечные точки (6)

• Positive symptoms [Срок оценки: 12 weeks]
• Mood symptoms [Срок оценки: 12 weeks]
• Quality of life: Short Form (36) Health Survey [Срок оценки: 12 weeks]
• Global functioning [Срок оценки: 12 weeks]
• Social anxiety [Срок оценки: 12 weeks]
• Adverse effects [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Diagnosis of schizophrenia made by the treating psychiatrist and corroborated by a team's psychiatrist under CIE-10 criteria.
• Age between 18 to 65 years-old.
• Outpatient setting,
• Clinical stability defined as no psychiatric hospitalizations in the last 6 months and not currently on queue for psychiatric hospitalization.
• No concomitant active substance abuse disorder, excluding nicotine.
• Subjects are capable of providing informed consent.

Критерии исключения

• Previous diagnosis of learning disability according either to ICD- 10 or clinical history
• Verbal expression difficulties, determined by language or medical causes.
• Deafness and/or blindness.
• Other physical handicaps to use VR devices.
• Predominant positive symptoms, defined as PANNS-C > 0.
• Catatonic symptoms.
• Previous epilepsy diagnosis.
• Neurodegenerative disease.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Чили · 1 центр

• Hospital Clínico La Florida — Santiago

Публикации

• Saha S, Chant D, Welham J, McGrath J. A systematic review of the prevalence of schizophrenia. PLoS Med. 2005 May;2(5):e141. doi: 10.1371/journal.pmed.0020141. Epub 2005 May 31. PMID 15916472
• McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemiol Rev. 2008;30:67-76. doi: 10.1093/epirev/mxn001. Epub 2008 May 14. PMID 18480098
• Vicente B, Rioseco P, Saldivia S, Kohn R, Torres S. [Chilean study on the prevalence of psychiatric disorders (DSM-III-R/CIDI) (ECPP)]. Rev Med Chil. 2002 May;130(5):527-36. Spanish. PMID 12143273
• Gonzalez-Valderrama A, Jongsma HE, Mena C, Castaneda CP, Nachar R, Undurraga J, Crossley N, Aceituno D, Iruretagoyena B, Gallardo C, Mondaca P, Monje M, Irarrazaval M, Zavala C, Valmaggia L, Kirkbride JB. The incidence of non-affective psychotic disorders in Chile between 2005 and 2018: results from a national register of over 30 000 cases. Psychol Med. 2022 Apr;52(5):914-923. doi: 10.1017/S003329 PMID 32758314
• GBD 2019 Mental Disorders Collaborators. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10. PMID 35026139
• Cloutier M, Aigbogun MS, Guerin A, Nitulescu R, Ramanakumar AV, Kamat SA, DeLucia M, Duffy R, Legacy SN, Henderson C, Francois C, Wu E. The Economic Burden of Schizophrenia in the United States in 2013. J Clin Psychiatry. 2016 Jun;77(6):764-71. doi: 10.4088/JCP.15m10278. PMID 27135986
• Hjorthoj C, Sturup AE, McGrath JJ, Nordentoft M. Years of potential life lost and life expectancy in schizophrenia: a systematic review and meta-analysis. Lancet Psychiatry. 2017 Apr;4(4):295-301. doi: 10.1016/S2215-0366(17)30078-0. Epub 2017 Feb 22. PMID 28237639
• Saha S, Chant D, McGrath J. A systematic review of mortality in schizophrenia: is the differential mortality gap worsening over time? Arch Gen Psychiatry. 2007 Oct;64(10):1123-31. doi: 10.1001/archpsyc.64.10.1123. PMID 17909124

Идентификаторы

NCT: NCT06588270 · SA20I0002 · SA20I0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗