VR-assisted CBT for Adolescents With Psychosis

Sponsor
Haukeland University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04586868
Collaborator
Helse Stavanger HF (Other)
120
1
1
54
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: An intervention development study
  • Behavioral: A randomized feasibility study
  • Behavioral: A single-case study
N/A

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

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. Acceptability for a virtual reality intervention [5 months]

    Semi-structured interview

  2. Social self-efficacy [1 week before, and 10 minutes after treatment.]

    Adolescent self-efficacy scale (S-EFF)

  3. Social interaction and social phobia [1 week before, and 10 minutes after treatment.]

    Short Form Social Interaction Anxiety Scale/Social Phobia Scale (SIAS-6/SPS-6)

  4. Social paranoia [1 week before and 1 week after treatment.]

    State Social Paranoia Scale (SSPS)

Secondary Outcome Measures

  1. Self-esteem [1 week before, and 10 minutes after treatment.]

    Rosenberg Self-Esteem scale (RSES)

  2. Psychotic symptoms [1 week before and 1 week after treatment.]

    Brief Psychiatric Rating Scale (BPRS)

  3. The experience of presence [10 minutes after treatment]

    Gatineau Presence Questionnaire (GPQ)

  4. Unwanted side effect [10 minutes before and 10 minutes after treatment]

    Virtual Reality Sickness Questionnaire (VRSQ)

Other Outcome Measures

  1. Level of functioning [1 week after treatment.]

    Children's Global Assessment Scale (C-GAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Haukeland university hospital Bergen Norway

Sponsors and Collaborators

  • Haukeland University Hospital
  • Helse Stavanger HF

Investigators

  • Study Director: Irene Elgen, phd, Haukeland University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT04586868
Other Study ID Numbers:
  • 95428
First Posted:
Oct 14, 2020
Last Update Posted:
Jul 1, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haukeland University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022