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

NCT04902066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2024-11-18

No results posted yet for this study

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.

Conditions

  • Paranoid Schizophrenia
  • Schizophrenia and Related Disorders
  • Schizophrenia Prodromal
  • Schizotypal Disorder
  • Paranoid Ideation
  • Paranoid Delusion
  • Ideas of Reference
  • Psychosis Paranoid
  • Psychotic Disorders
  • Psychotic Paranoia
  • Psychotic; Disorder, Delusional

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.

Sponsors & Collaborators

  • Central Denmark Region

    collaborator OTHER

  • Mental Health Services in the North Denmark Region

    collaborator UNKNOWN

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2024-03-21
Completion
2024-08-10

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902066 on ClinicalTrials.gov