VR-assisted CBT for Adolescents With Psychosis

Haukeland University Hospital

Status: Enrolling

Conditions: Psychotic Disorders

Treatments: Behavioral: An intervention development study; Behavioral: A single-case study; Behavioral: A randomized feasibility study

Study type: Interventional

Funder types: Other

Identifiers

NCT04586868

95428

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

A psychotic disorder

Experimental group

Description:

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

Treatment:

Behavioral: A single-case study

Behavioral: A randomized feasibility study

Behavioral: An intervention development study