VR-assisted CBT for Adolescents With Psychosis

Study Overview
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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.

Official Title
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VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Behavioral: An intervention development study
* Behavioral: A randomized feasibility study
* Behavioral: A single-case study


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A psychotic disorder<br>Patients, age 13-18 years old, diagnosed with a psychotic disorder (WHO ICD-10 ) | Behavioral: An intervention development study<br>* Assessing the acceptability for a virtual reality intervention among adolescents with psychosis<br>Behavioral: A randomized feasibility study<br>* Feasibility of virtual reality environment for adolescents with psychosis<br>Behavioral: A single-case study<br>* The clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability for a virtual reality intervention | Semi-structured interview | 5 months | 
| Social self-efficacy | Adolescent self-efficacy scale (S-EFF) | 1 week before, and 10 minutes after treatment. | 
| Social interaction and social phobia | Short Form Social Interaction Anxiety Scale/Social Phobia Scale (SIAS-6/SPS-6) | 1 week before, and 10 minutes after treatment. | 
| Social paranoia | State Social Paranoia Scale (SSPS) | 1 week before and 1 week after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-esteem | Rosenberg Self-Esteem scale (RSES) | 1 week before, and 10 minutes after treatment. | 
| Psychotic symptoms | Brief Psychiatric Rating Scale (BPRS) | 1 week before and 1 week after treatment. | 
| The experience of presence | Gatineau Presence Questionnaire (GPQ) | 10 minutes after treatment | 
| Unwanted side effect | Virtual Reality Sickness Questionnaire (VRSQ) | 10 minutes before and 10 minutes after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, Adolescents, Virtual Reality treatment, Cognitive Behavioural Therapy, Early onset psychosis, VR-assisted therapy