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COMPLETED
NCT04902066
NA

Face Your Fears: Cognitive Behavioural Virtual Reality Therapy for "Paranoia".

Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

View on ClinicalTrials.gov

Summary

The study is a randomised, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. A total of 256 patients will be allocated to either Cognitive Behavioural Virtual Reality Therapy plus treatment as usual, versus traditional CBT for psychosis plus treatment as usual. All participants will be assessed at baseline and 3- and 9 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles.

Official title: Face Your Fears: An Assessor-blinded, RCT Evaluating the Effectiveness of Cognitive Behavioural Virtual Reality Therapy Versus Cognitive Behavioural Therapy in Patients With Schizophrenia Spectrum Disorders.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

259

Start Date

2021-04-09

Completion Date

2024-08-10

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

OTHER

Cognitive Behavioural Virtual Reality Therapy.

Cognitive Behavioural Therapy augmented with Virtual Reality.

OTHER

Traditional Cognitive Behavioural Therapy

Traditional Cognitive Behavioural Therapy for psychosis.

Locations (1)

Copenhagen Research Center for Mental Health - CORE

Copenhagen, Hellerup, Denmark