Clinical trial NCT04661163: CHALLENGE. A Randomised Clinical Trial Examining Virtual Reality Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Hallucinations
Keywords: Avatar
Schizophrenia
Auditory Hallucinations
Psychotherapy
Virtual Reality
Psychosis
Virtual Reality Therapy
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Mental Health Services in the North Denmark Region
First posted: 2020-12-10
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised, assessor-blinded parallel-groups superiority clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Level of auditory hallucinations
timeFrame: 12 weeks from inclusion
Secondary outcomes:
measure: Frequency of auditory hallucinations
timeFrame: 12 weeks from inclusion
measure: Distress caused by auditory hallucinations
timeFrame: 12 weeks from inclusion
measure: Voice acceptance
timeFrame: 12 weeks from inclusion
measure: Assertive Responding to Voices
timeFrame: 12 weeks from inclusion
measure: Personal and social performance
timeFrame: 12 weeks from inclusion
measure: Perceived voice power
timeFrame: 12 weeks from inclusion
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Research Center for Mental Health - CORE
state: Hellerup
Study officials:
affiliation: Mental Health Services Capitol of Denmark; Copenhagen Research Center for Mental Health - CORE
name: Merete Nordentoft, professor
role: PRINCIPAL_INVESTIGATOR
References: