VR-assisted CBT for Adolescents With Psychosis

VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders
• Intervention / Treatment: Behavioral: An intervention development study; Behavioral: A randomized feasibility study; Behavioral: A single-case study

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anita Barsnes, MA; Phone Number: 004790922186; Email: anita.barsnes@helse-bergen.no
• Study Contact Backup: Name: Irene Elgen, phd; Phone Number: 004791550904; Email: irene.bircow.elgen@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Anita Barsnes, MA; Phone Number: 004790922186; Email: anita.barsnes@helse-bergen.no
    • Contact: Irene Elgen, phd; Phone Number: 004791550904; Email: irene.bircow.elgen@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of functioning	Children's Global Assessment Scale (C-GAS)	1 week after treatment.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Helse Stavanger HF
• Investigators: Study Director: Irene Elgen, phd, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Psychosis; Cognitive Behavioural Therapy; Early onset psychosis; Virtual Reality treatment; VR-assisted therapy
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 95428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No