Auditory HallucinationsNCT04661163
CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy
A study testing Psychotherapy in people with Auditory Hallucinations, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auditory Hallucinations
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Nov 2020to 2 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - years
- Ability to give informed consent
- A schizophrenia spectrum disorder (ICD-10 code: F20 -F29)
- Auditory hallucinations for at least three months, corresponding to a SAPS score on auditory hallucinations of ≥3.
- No changes in antipsychotic medication within the past four weeks and
- Not responding to current antipsychotic compound or
- Not responding to at least two antipsychotic compounds. Table2
Who cannot join
- Rejecting informed consent
- Unable to identify a single dominant voice to work on
- A diagnosis of organic brain disease
- Substance to a level that hinders engagement in therapy.
- Auditory hallucinations in a language not spoken by the therapists
- A command of spoken Danish or English inadequate for engaging in therapy
- Inability to tolerate the assessment process
- Strongly impaired vision
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Research Center for Mental Health - CORE
Copenhagen, Hellerup, 2900
About this study
Official title: The CHALLENGE-trial: the Effects of a Virtual Reality-assisted Exposure Therapy for Persistent Auditory Hallucinations Versus Supportive Counselling in People With Psychosis
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.
Read the detailed description
Auditory hallucinations are among the most frequent symptoms in psychotic disorders. While a large group of patients with first episode psychosis achieve remission of psychotic symptoms during first year after initial contact with mental health services, almost one third continue having psychotic symptoms in spite of treatment with antipsychotic medication. Since auditory hallucinations are a major cause of distress and suffering for these patients, there is an essential need to test the effectives of targeted psychotherapeutic interventions in alleviating auditory hallucinations Two previous trials have provided preliminary evidence of the effectiveness of virtual reality therapy on auditory hallucinations, but no trial to date has examined the effect of virtual reality assisted therapy in an adequately powered RCT. In this large-scale randomized, clinical trial, patients in the experimental intervention will be receiving 7 sessions of virtual reality assisted avatar therapy while patients in the control group will receive 7 sessions of supportive contact with mental health care professionals at their regular outpatient clinic.
If the virtual reality therapy is found to be beneficial in reducing the severity of refractory auditory hallucinations, it will be a breakthrough in the current treatment of psychotic disorders. A large group of patients with schizophrenia and related disorders in Denmark and worldwide will be the target group of the therapy. If proven effective, the treatment will be especially relevant for patients with treatment resistant schizophrenia, but the treatment can also be used as an add on to antipsychotic medication for patients with a better prognosis, such as patients with first episode psychosis. If the virtual reality therapy is proven effective, it can be implemented in mental health services in Denmark and internationally. A successful implementation could reduce the costs associated with treatment of schizophrenia.
- Conditions
- Auditory Hallucinations
- Being tested
- Psychotherapy
- Keywords
- Avatar, Schizophrenia, Auditory Hallucinations, Psychotherapy, Virtual Reality, Psychosis, Virtual Reality Therapy
- Medical subject headings
- Hallucinations, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
Also called Virtual Reality Avatar Therapy
Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality avatar therapy | Experimental | Patients will be offered seven individual sessions of virtual reality therapy and two booster sessions conducted by a skilled therapist. In the initial phase of treatment, the participants create a virtual avatar that corresponds to their visual perception of the source of their voice. The therapist initiates, encourages and supports a dialogue between the participant and the avatar by alternating between talking as the avatar and as a supportive therapist. The therapy sessions last 50 minutes of which around 15 minutes is spent in dialogue with the avatar. The remaining 30 minutes will be used on preparing the patient for the confrontation with the avatar, evaluating on the interaction with the avatar, and use general cognitive behavioral techniques to reduce the auditory hallucination. The treatment is conducted with the use of virtual reality, so the participant will wear VR headset during treatment and watch and talk with the avatar shown in front of him or her. Receives: Other: Psychotherapy |
| Supportive counselling (comparison group) | No intervention | The control group is offered seven session with health professionals providing supportive counselling. This can (but does not necessarily) involve psychotherapy targeting auditory hallucinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of auditory hallucinations
Level of auditory hallucinations measured with The Psychotic Symptoms Rating Scales (PSYRATS-AH) total score at cessation of treatment at 12-weeks (score on PSYRATS-AH: 0-44. A score of 0 is the minimum score and 44 is the maximum score i.e. a score of 44 is the worst possible outcome.
Measured: 12 weeks from inclusion
Secondary outcomes (6)
Frequency of auditory hallucinations
PSYRATS-AH-Frequency.
Measured: 12 weeks from inclusion
Distress caused by auditory hallucinations
PSYRATS-AH-Distress
Measured: 12 weeks from inclusion
Voice acceptance
Questionnaire: the Voices Acceptance and Action Scale (VAAS-Action)
Measured: 12 weeks from inclusion
Assertive Responding to Voices
Questionnaire: Assertive Responding to Voices (Approve - Voices), The assertive subscale (5 items with scores from 0-10, minimum score on this subscale is 0, maximum score is 50 with higher scores being a better outcome)
Measured: 12 weeks from inclusion
Personal and social performance
The personal and social performance scale (PSP); (Scores from 1-100, with a score of 100 being the best possible outcome).
Measured: 12 weeks from inclusion
Perceived voice power
Questionnaire: Voice Power Differential Scale, total score (range 7-35 with 7 being the minimum score and 35 the maximum score. Higher scores indicates greater power differential in favour of the voice - i.e. a worse outcome)
Measured: 12 weeks from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start16 Nov 2020
- Primary completion27 Feb 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Auditory HallucinationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised, assessor-blinded parallel-groups superiority clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Mental Health Services in the North Denmark Region
- Responsible party
- Sponsor
- Investigators
- Merete Nordentoft, professor, Principal investigator, Mental Health Services Capitol of Denmark; Copenhagen Research Center for Mental Health - CORE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661163
- Sponsor's protocol ID
- CHALLENGE
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2020
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith LC, Vernal DL, Mariegaard LS, Christensen AG, Jansen JE, Schytte G, Stokbro LA, Albert N, Christensen MJ, Thomas N, Hjorthoj C, Nordentoft M, Glenthoj LB. 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. Lancet Psychiatry. 2025 Aug;12(8):557-567. doi: 10.1016/S2215-0366(25)00161-0. Epub 2025 Jul 3.
PubMed 40617245
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHALLENGE-trial: the Effects of a Virtual Reality-assisted Exposure Therapy for Persistent Auditory Hallucinations Versus Supportive Counselling in People With Psychosis
- ClinicalTrials.gov ID
- NCT04661163
- Acronym / sponsor ID
- CHALLENGE
- Conditions
- Auditory Hallucinations
- Keywords
- Avatar, Schizophrenia, Auditory Hallucinations, Psychotherapy, Virtual Reality, Psychosis, Virtual Reality Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Mental Health Services in the North Denmark Region
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Auditory hallucinations are among the most frequent symptoms in psychotic disorders. While a large group of patients with first episode psychosis achieve remission of psychotic symptoms during first year after initial contact with mental health services, almost one third continue having psychotic symptoms in spite of treatment with antipsychotic medication. Since auditory hallucinations are a major cause of distress and suffering for these patients, there is an essential need to test the effectives of targeted psychotherapeutic interventions in alleviating auditory hallucinations Two previous trials have provided preliminary evidence of the effectiveness of virtual reality therapy on auditory hallucinations, but no trial to date has examined the effect of virtual reality assisted therapy in an adequately powered RCT. In this large-scale randomized, clinical trial, patients in the experimental intervention will be receiving 7 sessions of virtual reality assisted avatar therapy while patients in the control group will receive 7 sessions of supportive contact with mental health care professionals at their regular outpatient clinic.
If the virtual reality therapy is found to be beneficial in reducing the severity of refractory auditory hallucinations, it will be a breakthrough in the current treatment of psychotic disorders. A large group of patients with schizophrenia and related disorders in Denmark and worldwide will be the target group of the therapy. If proven effective, the treatment will be especially relevant for patients with treatment resistant schizophrenia, but the treatment can also be used as an add on to antipsychotic medication for patients with a better prognosis, such as patients with first episode psychosis. If the virtual reality therapy is proven effective, it can be implemented in mental health services in Denmark and internationally. A successful implementation could reduce the costs associated with treatment of schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised, assessor-blinded parallel-groups superiority clinical trial
| Arm | Type | Receives |
|---|---|---|
| Virtual reality avatar therapy | Experimental | Other: PsychotherapyPatients will be offered seven individual sessions of virtual reality therapy and two booster sessions conducted by a skilled therapist. In the initial phase of treatment, the participants create a virtual avatar that corresponds to their visual perception of the source of their voice. The therapist initiates, encourages and supports a dialogue between the participant and the avatar by alternating between talking as the avatar and as a supportive therapist. The therapy sessions last 50 minutes of which around 15 minutes is spent in dialogue with the avatar. The remaining 30 minutes will be used on preparing the patient for the confrontation with the avatar, evaluating on the interaction with the avatar, and use general cognitive behavioral techniques to reduce the auditory hallucination. The treatment is conducted with the use of virtual reality, so the participant will wear VR headset during treatment and watch and talk with the avatar shown in front of him or her. |
| Supportive counselling (comparison group) | No intervention | –The control group is offered seven session with health professionals providing supportive counselling. This can (but does not necessarily) involve psychotherapy targeting auditory hallucinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 - years
- Ability to give informed consent
- A schizophrenia spectrum disorder (ICD-10 code: F20 -F29)
- Auditory hallucinations for at least three months, corresponding to a SAPS score on auditory hallucinations of ≥3.
- No changes in antipsychotic medication within the past four weeks and
Key exclusion criteria (8 listed)
- Rejecting informed consent
- Unable to identify a single dominant voice to work on
- A diagnosis of organic brain disease
- Substance to a level that hinders engagement in therapy.
- Auditory hallucinations in a language not spoken by the therapists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyAlso: Virtual Reality Avatar TherapyVirtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations | Other | Virtual reality avatar therapy |
Primary outcome
Level of auditory hallucinations
Time frame: 12 weeks from inclusion
Level of auditory hallucinations measured with The Psychotic Symptoms Rating Scales (PSYRATS-AH) total score at cessation of treatment at 12-weeks (score on PSYRATS-AH: 0-44. A score of 0 is the minimum score and 44 is the maximum score i.e. a score of 44 is the worst possible outcome.
6 secondary outcomes
Frequency of auditory hallucinations
Time frame: 12 weeks from inclusion
Distress caused by auditory hallucinations
Time frame: 12 weeks from inclusion
Voice acceptance
Time frame: 12 weeks from inclusion
Assertive Responding to Voices
Time frame: 12 weeks from inclusion
Personal and social performance
Time frame: 12 weeks from inclusion
Perceived voice power
Time frame: 12 weeks from inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 40617245Smith LC, Vernal DL, Mariegaard LS, Christensen AG, Jansen JE, Schytte G, Stokbro LA, Albert N, Christensen MJ, Thomas N, Hjorthoj C, Nordentoft M, Glenthoj LB. 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. Lancet Psychiatry. 2025 Aug;12(8):557-567. doi: 10.1016/S2215-0366(25)00161-0. Epub 2025 Jul 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nordentoft, professor principal investigator
Mental Health Services Capitol of Denmark; Copenhagen Research Center for Mental Health - CORE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Auditory Hallucinations, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of auditory hallucinations (time frame: 12 weeks from inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04661163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.