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VR-assisted CBT for Adolescents With Psychosis

Primary Purpose

Psychotic Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
An intervention development study
A randomized feasibility study
A single-case study
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Psychosis, Adolescents, Virtual Reality treatment, Cognitive Behavioural Therapy, Early onset psychosis, VR-assisted therapy

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • Haukeland university hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A psychotic disorder

Arm Description

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

Outcomes

Primary Outcome Measures

Acceptability for a virtual reality intervention
Semi-structured interview
Social self-efficacy
Adolescent self-efficacy scale (S-EFF)
Social interaction and social phobia
Short Form Social Interaction Anxiety Scale/Social Phobia Scale (SIAS-6/SPS-6)
Social paranoia
State Social Paranoia Scale (SSPS)

Secondary Outcome Measures

Self-esteem
Rosenberg Self-Esteem scale (RSES)
Psychotic symptoms
Brief Psychiatric Rating Scale (BPRS)
The experience of presence
Gatineau Presence Questionnaire (GPQ)
Unwanted side effect
Virtual Reality Sickness Questionnaire (VRSQ)

Full Information

First Posted
September 16, 2020
Last Updated
April 28, 2023
Sponsor
Haukeland University Hospital
Collaborators
Helse Stavanger HF
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1. Study Identification

Unique Protocol Identification Number
NCT04586868
Brief Title
VR-assisted CBT for Adolescents With Psychosis
Official Title
VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Helse Stavanger HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Psychosis, Adolescents, Virtual Reality treatment, Cognitive Behavioural Therapy, Early onset psychosis, VR-assisted therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A psychotic disorder
Arm Type
Experimental
Arm Description
Patients, age 13-18 years old, diagnosed with a psychotic disorder (WHO ICD-10 )
Intervention Type
Behavioral
Intervention Name(s)
An intervention development study
Intervention Description
Assessing the acceptability for a virtual reality intervention among adolescents with psychosis
Intervention Type
Behavioral
Intervention Name(s)
A randomized feasibility study
Intervention Description
Feasibility of virtual reality environment for adolescents with psychosis
Intervention Type
Behavioral
Intervention Name(s)
A single-case study
Intervention Description
The clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis
Primary Outcome Measure Information:
Title
Acceptability for a virtual reality intervention
Description
Semi-structured interview
Time Frame
5 months
Title
Social self-efficacy
Description
Adolescent self-efficacy scale (S-EFF)
Time Frame
1 week before, and 10 minutes after treatment.
Title
Social interaction and social phobia
Description
Short Form Social Interaction Anxiety Scale/Social Phobia Scale (SIAS-6/SPS-6)
Time Frame
1 week before, and 10 minutes after treatment.
Title
Social paranoia
Description
State Social Paranoia Scale (SSPS)
Time Frame
1 week before and 1 week after treatment.
Secondary Outcome Measure Information:
Title
Self-esteem
Description
Rosenberg Self-Esteem scale (RSES)
Time Frame
1 week before, and 10 minutes after treatment.
Title
Psychotic symptoms
Description
Brief Psychiatric Rating Scale (BPRS)
Time Frame
1 week before and 1 week after treatment.
Title
The experience of presence
Description
Gatineau Presence Questionnaire (GPQ)
Time Frame
10 minutes after treatment
Title
Unwanted side effect
Description
Virtual Reality Sickness Questionnaire (VRSQ)
Time Frame
10 minutes before and 10 minutes after treatment
Other Pre-specified Outcome Measures:
Title
Level of functioning
Description
Children's Global Assessment Scale (C-GAS)
Time Frame
1 week after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anita Barsnes, MA
Phone
004790922186
Email
anita.barsnes@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Elgen, phd
Phone
004791550904
Email
irene.bircow.elgen@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Elgen, phd
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland university hospital
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Elgen, phd
Phone
004791550904
Email
irene.bircow.elgen@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Anita Barsnes, MA
Phone
004790922186
Email
anita.barsnes@helse-bergen.no

12. IPD Sharing Statement

Plan to Share IPD
No

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VR-assisted CBT for Adolescents With Psychosis

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