Clinical trial NCT04586868: VR-assisted CBT for Adolescents With Psychosis
Official title: VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotic Disorders
Keywords: Psychosis
Adolescents
Virtual Reality treatment
Cognitive Behavioural Therapy
Early onset psychosis
VR-assisted therapy
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
First posted: 2020-10-14
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Acceptability for a virtual reality intervention
timeFrame: 5 months
measure: Social self-efficacy
timeFrame: 1 week before, and 10 minutes after treatment.
measure: Social interaction and social phobia
timeFrame: 1 week before, and 10 minutes after treatment.
measure: Social paranoia
timeFrame: 1 week before and 1 week after treatment.
Secondary outcomes:
measure: Self-esteem
timeFrame: 1 week before, and 10 minutes after treatment.
measure: Psychotic symptoms
timeFrame: 1 week before and 1 week after treatment.
measure: The experience of presence
timeFrame: 10 minutes after treatment
measure: Unwanted side effect
timeFrame: 10 minutes before and 10 minutes after treatment
Other outcomes:
measure: Level of functioning
timeFrame: 1 week after treatment.
Locations:
city: Bergen
country: Norway
facility: Haukeland university hospital
Study officials:
affiliation: Haukeland University Hospital
name: Irene Elgen, phd
role: STUDY_DIRECTOR
References: