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NCT04661163
CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy
NA trial testing Psychotherapy in Auditory Hallucinations in 270 participants. Completed in 2 April 2024.
27 February 2024
Quick facts
| Lead sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 270 |
| Start date | 16 November 2020 |
| Primary completion | 27 February 2024 |
| Estimated completion | 2 April 2024 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Psychotherapy
Conditions studied
- Auditory Hallucinations — all drugs for Auditory Hallucinations →
Sponsor
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Who can join
18 and older, any sex, with Auditory Hallucinations. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The CHALLENGE trial: the effects of a virtual reality-assisted exposure therapy for persistent auditory hallucinations versus supportive counselling in people with psychosis: study protocol for a randomised clinical trial.
Smith LC, Mariegaard L, Vernal DL, Christensen AG, et al · · 2022 · cited 18× · PMID 36100943 · DOI 10.1186/s13063-022-06683-1 -
Immersive virtual reality-assisted therapy targeting persistent auditory verbal hallucinations in patients diagnosed with schizophrenia spectrum disorders in Denmark: the Challenge assessor-masked, randomised clinical trial.
Smith LC, Vernal DL, Mariegaard LS, Christensen AG, et al · · 2025 · cited 10× · PMID 40617245 · DOI 10.1016/s2215-0366(25)00161-0 -
Virtual reality-assisted therapy targeting persistent auditory verbal hallucinations in patients diagnosed with schizophrenia spectrum disorders: the Challenge single-blind, randomized clinical trial
Glenthøj L, Smith L, Vernal D, Mariegaard L, et al · · 2024 · cited 3× · DOI 10.21203/rs.3.rs-5180922/v1 -
Patient perspectives on modified virtual reality-assisted therapy for persistent auditory verbal hallucinations: A qualitative substudy of the CHALLENGE randomized clinical trial.
Rasmussen K, Vernal DL, Mariegaard LS, Jørgensen G, et al · · 2026 · PMID 41585296 · DOI 10.1177/20552076251411033
Verify or expand the search:
- PubMed search for NCT04661163
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04661163 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Last refreshed: 25 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04661163.
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