Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

VR-assisted CBT for Adolescents With Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586868
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Helse Stavanger HF
Information provided by (Responsible Party):
Haukeland University Hospital

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 feasibility study Behavioral: A randomized controlled trial 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 mixed methods study, assessing the tolerability and feasibility of a novel VR-assisted CBT interventions for adolescents with psychosis. Third, assessing the clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis, through a randomized controlled trial (RCT).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A psychotic disorder
Patients, age 13-19 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 feasibility study
Assessing the tolerability and feasibility of a novel VR-assisted CBT interventions for adolescents with psychosis.

Behavioral: A randomized controlled trial
Assessing the clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis, a randomized controlled trial.




Primary Outcome Measures :
  1. Assess the acceptability for a virtual reality intervention for adolescents with psychosis, using a semi-structured interview [ Time Frame: 5 months ]
  2. Change in social self-efficacy after receiving VR-assisted CBT, assessed by the adolescent self-efficacy scale (S-EFF) [ Time Frame: 1 week before, and 10 minutes after treatment. ]
  3. Assessing anxiety and stress symptoms after receiving VR- assisted CBT, using the anxiety and stress subscales of the Depression Anxiety Stress Scales (DASS) [ Time Frame: 1 week before, and 10 minutes after treatment. ]
  4. Change in function after receiving VR-assisted CBT, assessed by the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) [ Time Frame: 1 week before and 1 week after treatment. ]

Secondary Outcome Measures :
  1. Change in self-esteem after receiving VR-assisted CBT, assessed by the Rosenberg Self-Esteem scale (RSES) [ Time Frame: 1 week before, and 10 minutes after treatment. ]
  2. Assessing psychotic symptoms after receiving VR- assisted CBT, using the Positive and Negative Syndrome in Schizophrenia Scale (PANSS) [ Time Frame: 1 week before and 1 week after treatment. ]
  3. Assessing the experience of presence in the VR-scenarios using the 4-item Gatineau Presence Questionnaire (GPQ) [ Time Frame: 10 minutes after treatment ]
  4. Assess unwanted side effect of the VR-scenarios using the Virtual Reality Sickness Questionnaire (VRSQ) [ Time Frame: 10 minutes before and 10 minutes after treatment ]

Other Outcome Measures:
  1. Assess how adolescents with psychosis experiences a novel VR-assisted CBT intervention, using a semi-structured interview [ Time Frame: 1 week after treatment. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 19 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.

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

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Irene Elgen, phd Haukeland University Hospital
Layout table for additonal information
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 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders