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VR-assisted CBT for Adolescents With Psychosis

VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04586868
Enrollment
120
Registered
2020-10-14
Start date
2020-06-01
Completion date
2024-12-31
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders

Keywords

Psychosis, Adolescents, Virtual Reality treatment, Cognitive Behavioural Therapy, Early onset psychosis, VR-assisted therapy

Brief summary

Psychotic disorders typically emerge during late adolescence or early adulthood. Patients, who are diagnosed with a psychotic disorder before turning 18 years, are defined as early onset psychosis patients (EOP). Relative to adult patients, these patients show a worse long-term prognoses. Social impairment present a major barrier towards recovery, and thus and important issue to address in treatment. Cognitive behavioral therapy (CBT) is the recommended psychological treatment for psychotic disorders. As part of the therapy, the patient does an exposure-based training in a social environment. This type of training has several limitations for patients with psychosis. The last decade there has been a growing interest in using virtual reality (VR) to understand and treat various psychological disorders. There is a lack of research on VR-interventions for EOP patients. This study will assess the acceptability, tolerability, feasibility and clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis.

Detailed description

This study adhere to the model for research made by the international Virtual Reality Clinical Outcomes Research Experts groups (VR-CORE). The study consist of three sub-studies. First a qualitative study assessing the acceptability for VR among adolescence with psychosis. Secondly, a randomized study of the feasibility of virtual reality environment for adolescents with psychosis. Third, assessing the clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis, through a non-randomized single-case study.

Interventions

BEHAVIORALAn intervention development study

Assessing the acceptability for a virtual reality intervention among adolescents with psychosis

BEHAVIORALA randomized feasibility study

Feasibility of virtual reality environment for adolescents with psychosis

BEHAVIORALA single-case study

The clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis

Sponsors

Helse Stavanger HF
CollaboratorOTHER_GOV
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Suffering from a psychotic disorder (ICD-10 WHO) * In stable clinical condition (i.e. not hospitalized) * Being able to speak Norwegian or a Scandinavian language, or English * Able to provide informed consent.

Exclusion criteria

* Primary neurological or endocrinological disorder * Started a transfer-process to Department of Adult Psychiatry.

Design outcomes

Primary

MeasureTime frameDescription
Social paranoia1 week before and 1 week after treatment.State Social Paranoia Scale (SSPS)
Acceptability for a virtual reality intervention5 monthsSemi-structured interview
Social self-efficacy1 week before, and 10 minutes after treatment.Adolescent self-efficacy scale (S-EFF)
Social interaction and social phobia1 week before, and 10 minutes after treatment.Short Form Social Interaction Anxiety Scale/Social Phobia Scale (SIAS-6/SPS-6)

Secondary

MeasureTime frameDescription
Unwanted side effect10 minutes before and 10 minutes after treatmentVirtual Reality Sickness Questionnaire (VRSQ)
Self-esteem1 week before, and 10 minutes after treatment.Rosenberg Self-Esteem scale (RSES)
Psychotic symptoms1 week before and 1 week after treatment.Brief Psychiatric Rating Scale (BPRS)
The experience of presence10 minutes after treatmentGatineau Presence Questionnaire (GPQ)

Other

MeasureTime frameDescription
Level of functioning1 week after treatment.Children's Global Assessment Scale (C-GAS)

Countries

Norway

Contacts

Primary ContactAnita Barsnes, MA
anita.barsnes@helse-bergen.no004790922186
Backup ContactIrene Elgen, phd
irene.bircow.elgen@helse-bergen.no004791550904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026