Psychotic DisordersNCT04586868
VR-assisted CBT for Adolescents With Psychosis
A study testing An intervention development study, A randomized feasibility study and A single-case study in people with Psychotic Disorders, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- An intervention development study, A randomized feasibility study and A single-case study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Primary neurological or endocrinological disorder
- Started a "transfer-process" to Department of Adult Psychiatry.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland university hospital
Bergen
Irene Elgen, phd, 004791550904, irene.bircow.elgen@helse-bergen.no
Anita Barsnes, MA, 004790922186, anita.barsnes@helse-bergen.no
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychotic Disorders
- Being tested
- An intervention development study, A randomized feasibility study, A single-case study
- Keywords
- Psychosis, Adolescents, Virtual Reality treatment, Cognitive Behavioural Therapy, Early onset psychosis, VR-assisted therapy
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An intervention development studyBehavioural
Assessing the acceptability for a virtual reality intervention among adolescents with psychosis
A randomized feasibility studyBehavioural
Feasibility of virtual reality environment for adolescents with psychosis
A single-case studyBehavioural
The clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis
| Study group | Role | What they receive |
|---|---|---|
| A psychotic disorder | Experimental | Patients, age 13-18 years old, diagnosed with a psychotic disorder (WHO ICD-10 ) Receives: Behavioral: An intervention development study; Behavioral: A randomized feasibility study; Behavioral: A single-case study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability for a virtual reality intervention
Semi-structured interview
Measured: 5 months
Social self-efficacy
Adolescent self-efficacy scale (S-EFF)
Measured: 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)
Measured: 1 week before, and 10 minutes after treatment.
Social paranoia
State Social Paranoia Scale (SSPS)
Measured: 1 week before and 1 week after treatment.
Secondary outcomes (4)
Self-esteem
Rosenberg Self-Esteem scale (RSES)
Measured: 1 week before, and 10 minutes after treatment.
Psychotic symptoms
Brief Psychiatric Rating Scale (BPRS)
Measured: 1 week before and 1 week after treatment.
The experience of presence
Gatineau Presence Questionnaire (GPQ)
Measured: 10 minutes after treatment
Unwanted side effect
Virtual Reality Sickness Questionnaire (VRSQ)
Measured: 10 minutes before and 10 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jun 2020
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF
- Responsible party
- Sponsor
- Investigators
- Irene Elgen, phd, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586868
- Sponsor's protocol ID
- 95428
- Status last verified
- Mar 2023
- First submitted
- 16 Sep 2020
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35708166
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis
- ClinicalTrials.gov ID
- NCT04586868
- Acronym / sponsor ID
- 95428
- Conditions
- Psychotic Disorders
- Keywords
- Psychosis, Adolescents, Virtual Reality treatment, Cognitive Behavioural Therapy, Early onset psychosis, VR-assisted therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A psychotic disorder | Experimental | Behavioral: An intervention development study, Behavioral: A randomized feasibility study, Behavioral: A single-case studyPatients, age 13-18 years old, diagnosed with a psychotic disorder (WHO ICD-10 ) |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Primary neurological or endocrinological disorder
- Started a "transfer-process" to Department of Adult Psychiatry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An intervention development studyAssessing the acceptability for a virtual reality intervention among adolescents with psychosis | Behavioural | A psychotic disorder |
| A randomized feasibility studyFeasibility of virtual reality environment for adolescents with psychosis | Behavioural | A psychotic disorder |
| A single-case studyThe clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis | Behavioural | A psychotic disorder |
Primary outcome
Acceptability for a virtual reality intervention
Time frame: 5 months
Semi-structured interview
Social self-efficacy
Time frame: 1 week before, and 10 minutes after treatment.
Adolescent self-efficacy scale (S-EFF)
Social interaction and social phobia
Time frame: 1 week before, and 10 minutes after treatment.
Short Form Social Interaction Anxiety Scale/Social Phobia Scale (SIAS-6/SPS-6)
Social paranoia
Time frame: 1 week before and 1 week after treatment.
State Social Paranoia Scale (SSPS)
4 secondary outcomes
Self-esteem
Time frame: 1 week before, and 10 minutes after treatment.
Psychotic symptoms
Time frame: 1 week before and 1 week after treatment.
The experience of presence
Time frame: 10 minutes after treatment
Unwanted side effect
Time frame: 10 minutes before and 10 minutes after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 35708166Holgersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Elgen, phd study director
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An intervention development study, A randomized feasibility study and A single-case study in people with Psychotic Disorders, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anita Barsnes, MA (004790922186, anita.barsnes@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability for a virtual reality intervention (time frame: 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04586868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.