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VR-assisted CBT for Adolescents With Psychosis

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ClinicalTrials.gov Identifier: NCT04586868
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 4, 2021
Sponsor:
Collaborator:
Helse Stavanger HF
Information provided by (Responsible Party):
Haukeland University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Behavioral: An intervention development study Behavioral: A randomized feasibility study Behavioral: A single-case study Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Acceptability for a virtual reality intervention [ Time Frame: 5 months ]
    Semi-structured interview

  2. Social self-efficacy [ Time Frame: 1 week before, and 10 minutes after treatment. ]
    Adolescent self-efficacy scale (S-EFF)

  3. 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)

  4. Social paranoia [ Time Frame: 1 week before and 1 week after treatment. ]
    State Social Paranoia Scale (SSPS)


Secondary Outcome Measures :
  1. Self-esteem [ Time Frame: 1 week before, and 10 minutes after treatment. ]
    Rosenberg Self-Esteem scale (RSES)

  2. Psychotic symptoms [ Time Frame: 1 week before and 1 week after treatment. ]
    Brief Psychiatric Rating Scale (BPRS)

  3. The experience of presence [ Time Frame: 10 minutes after treatment ]
    Gatineau Presence Questionnaire (GPQ)

  4. Unwanted side effect [ Time Frame: 10 minutes before and 10 minutes after treatment ]
    Virtual Reality Sickness Questionnaire (VRSQ)


Other Outcome Measures:
  1. Level of functioning [ Time Frame: 1 week after treatment. ]
    Children's Global Assessment Scale (C-GAS)


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586868


Contacts
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Contact: Guri-Elise Holgersen, MA 004790737908 guri-elise.holgersen@helse-bergen.no
Contact: Irene Elgen, phd 004791550904 irene.bircow.elgen@helse-bergen.no

Locations
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Norway
Haukeland university hospital Recruiting
Bergen, Norway
Contact: Irene Elgen, phd    004791550904    irene.bircow.elgen@helse-bergen.no   
Contact: Guri-Elise Holgersen, MA    004790737908    guri-elise.holgersen@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Helse Stavanger HF
Investigators
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Study Director: Irene Elgen, phd Haukeland University Hospital
More Information
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04586868    
Other Study ID Numbers: 95428
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
Psychosis
Adolescents
Virtual Reality treatment
 Cognitive Behavioural Therapy
Early onset psychosis
VR-assisted therapy
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders