MedTrace Logo

CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy

NCT04661163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2024-11-25

No results posted yet for this study

Summary

The study is a randomised, assessor-blinded parallel-groups superiority clinical trial, allocating a total of 266 patients to either the experimental intervention or standard intervention. The participants will be randomised to either 12-weeks of virtual reality therapy or supportive counselling. All participants will be assessed at 12- and 24 weeks 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

  • Auditory Hallucinations

Interventions

OTHER

Psychotherapy

Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • Mental Health Services in the North Denmark Region

    collaborator UNKNOWN

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Merete Nordentoft, professor · Mental Health Services Capitol of Denmark; Copenhagen Research Center for Mental Health - CORE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2024-02-27
Completion
2024-04-02

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT04661163 on ClinicalTrials.gov