NCT04586868

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 1, 2023

Status Verified

March 1, 2023

Enrollment Period

4.1 years

First QC Date

September 16, 2020

Last Update Submit

April 28, 2023

Conditions

Psychotic Disorders

Keywords

PsychosisAdolescentsVirtual Reality treatmentCognitive Behavioural TherapyEarly onset psychosisVR-assisted therapy

Outcome Measures

Primary Outcomes (4)

  • Acceptability for a virtual reality intervention

    Semi-structured interview

    5 months

  • Social self-efficacy

    Adolescent self-efficacy scale (S-EFF)

    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)

    1 week before, and 10 minutes after treatment.

  • Social paranoia

    State Social Paranoia Scale (SSPS)

    1 week before and 1 week after treatment.

Secondary Outcomes (4)

  • Self-esteem

    1 week before, and 10 minutes after treatment.

  • Psychotic symptoms

    1 week before and 1 week after treatment.

  • The experience of presence

    10 minutes after treatment

  • Unwanted side effect

    10 minutes before and 10 minutes after treatment

Other Outcomes (1)

  • Level of functioning

    1 week after treatment.

Study Arms (1)

A psychotic disorder

EXPERIMENTAL

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

Behavioral: An intervention development studyBehavioral: A randomized feasibility studyBehavioral: A single-case study

Interventions

An intervention development studyBEHAVIORAL

Assessing the acceptability for a virtual reality intervention among adolescents with psychosis

A psychotic disorder
A randomized feasibility studyBEHAVIORAL

Feasibility of virtual reality environment for adolescents with psychosis

A psychotic disorder
A single-case studyBEHAVIORAL

The clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis

A psychotic disorder

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Primary neurological or endocrinological disorder
  • Started a "transfer-process" to Department of Adult Psychiatry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland university hospital

Bergen, Norway

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35708166DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Irene Elgen, phd

    Haukeland University Hospital

    STUDY DIRECTOR

Central Study Contacts

Anita Barsnes, MA

CONTACT

004790922186anita.barsnes@helse-bergen.no

Irene Elgen, phd

CONTACT

004791550904irene.bircow.elgen@helse-bergen.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

October 14, 2020

Study Start

June 1, 2020

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

May 1, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)