CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy

NCT ID: NCT04661163

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2024-04-02

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual reality avatar therapy

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.

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: OTHER

Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations

Supportive counselling (comparison group)

The control group is offered seven session with health professionals providing supportive counselling. This can (but does not necessarily) involve psychotherapy targeting auditory hallucinations.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychotherapy

Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations

Intervention Type: OTHER

Other Intervention Names

Virtual Reality Avatar Therapy

Eligibility Criteria

Inclusion Criteria

1. Age 18 - years

2. Ability to give informed consent

3. A schizophrenia spectrum disorder (ICD-10 code: F20 -F29)

4. Auditory hallucinations for at least three months, corresponding to a SAPS score on auditory hallucinations of ≥3.

5. No changes in antipsychotic medication within the past four weeks and

1. Not responding to current antipsychotic compound or

2. Not responding to at least two antipsychotic compounds. Table2

Exclusion Criteria

1. Rejecting informed consent

2. Unable to identify a single dominant voice to work on

3. A diagnosis of organic brain disease

4. Substance to a level that hinders engagement in therapy.

5. Auditory hallucinations in a language not spoken by the therapists

6. A command of spoken Danish or English inadequate for engaging in therapy

7. Inability to tolerate the assessment process

8. Strongly impaired vision

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

Mental Health Services in the North Denmark Region

UNKNOWN

Sponsor Role: collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merete Nordentoft, professor

Role: PRINCIPAL_INVESTIGATOR

Mental Health Services Capitol of Denmark; Copenhagen Research Center for Mental Health - CORE

Locations

Copenhagen Research Center for Mental Health - CORE

Copenhagen, Hellerup, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 40617245 (View on PubMed)

Other Identifiers

CHALLENGE

Identifier Type: -

Identifier Source: org_study_id