Auditory Hallucinations
Conditions
Keywords
Avatar, Schizophrenia, Auditory Hallucinations, Psychotherapy, Virtual Reality, Psychosis, Virtual Reality Therapy
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.
Interventions
OTHERPsychotherapy
Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations
Sponsors
Region of Southern Denmark
Mental Health Services in the North Denmark Region
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Independent assessors blinded to the treatment will evaluate outcome.
Intervention model description
A randomised, assessor-blinded parallel-groups superiority clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of auditory hallucinations | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Personal and social performance | 12 weeks from inclusion | The personal and social performance scale (PSP); (Scores from 1-100, with a score of 100 being the best possible outcome). |
| Frequency of auditory hallucinations | 12 weeks from inclusion | PSYRATS-AH-Frequency. |
| Assertive Responding to Voices | 12 weeks from inclusion | 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) |
| Voice acceptance | 12 weeks from inclusion | Questionnaire: the Voices Acceptance and Action Scale (VAAS-Action) |
| Perceived voice power | 12 weeks from inclusion | 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) |
| Distress caused by auditory hallucinations | 12 weeks from inclusion | PSYRATS-AH-Distress |
Countries
Denmark
Outcome results
None listed