CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The CHALLENGE-trial: the Effects of a Virtual Reality-assisted Exposure Therapy for Persistent Auditory Hallucinations Versus Supportive Counselling in People With Psychosis

Conditions
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Auditory Hallucinations

Intervention / Treatment
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* Other: Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomised, assessor-blinded parallel-groups superiority clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality avatar therapy<br>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. | Other: Psychotherapy<br>* Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations<br>* Other names: Virtual Reality Avatar Therapy;|
| No Intervention: Supportive counselling (comparison group)<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of auditory hallucinations | PSYRATS-AH-Frequency. | 12 weeks from inclusion | 
| Distress caused by auditory hallucinations | PSYRATS-AH-Distress | 12 weeks from inclusion | 
| Voice acceptance | Questionnaire: the Voices Acceptance and Action Scale (VAAS-Action) | 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) | 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). | 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) | 12 weeks from inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avatar, Schizophrenia, Auditory Hallucinations, Psychotherapy, Virtual Reality, Psychosis, Virtual Reality Therapy