VR-assisted CBT for Adolescents With Psychosis

NCT ID: NCT04586868

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Psychotic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A psychotic disorder

Patients, age 13-18 years old, diagnosed with a psychotic disorder (WHO ICD-10 )

Group Type EXPERIMENTAL

An intervention development study

Intervention Type BEHAVIORAL

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

A randomized feasibility study

Intervention Type BEHAVIORAL

Feasibility of virtual reality environment for adolescents with psychosis

A single-case study

Intervention Type BEHAVIORAL

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

Interventions

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An intervention development study

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

Intervention Type BEHAVIORAL

A randomized feasibility study

Feasibility of virtual reality environment for adolescents with psychosis

Intervention Type BEHAVIORAL

A single-case study

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irene Elgen, phd

Role: STUDY_DIRECTOR

Haukeland University Hospital

Locations

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Haukeland university hospital

Bergen, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Anita Barsnes, MA

Role: CONTACT

004790922186

Irene Elgen, phd

Role: CONTACT

004791550904

Facility Contacts

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Irene Elgen, phd

Role: primary

004791550904

Anita Barsnes, MA

Role: backup

004790922186

References

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Holgersen G, Nordgreen T, Ten Velden Hegelstad W, Bircow Elgen I. Views of young people with psychosis on using virtual reality assisted therapy. A qualitative study. Early Interv Psychiatry. 2023 Apr;17(4):361-367. doi: 10.1111/eip.13331. Epub 2022 Jun 16.

Reference Type DERIVED
PMID: 35708166 (View on PubMed)

Other Identifiers

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95428

Identifier Type: -

Identifier Source: org_study_id

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