Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia

Study Overview
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Brief Summary
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Treatment of verbal hallucinations in schizophrenia is clinically challenging for both the patient and the therapist. For the therapist, one of the main difficulties arises from the impossibility of directly communicating with the entity persecuting the patient. For the patient, the therapeutic process is challenging because it aims at getting to better cope with an entity that keeps repeating stereotyped and abusive sentences without having the emotional strength to reply to the persecutor. To help overcome these clinical challenges, virtual reality enable patients to recreate the face and the voice of their persecutor.The hypothesis is that the engagement of patients in a dialogue with an external representation of their persecutor, with the support of the therapist, would help them to gain better control over their voices.

Official Title
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Emotion Regulation Using Virtual Reality in Schizophrenia: a Clinical and Mechanistic Trial of Avatar Therapy for Refractory Auditory Hallucinations

Conditions
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Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia

Intervention / Treatment
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* Behavioral: Avatar therapy
* Other: Treatment-as-usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: distressing auditory verbal hallucinations medication resistance relating to auditory verbal hallucinations (no response after 3 antipsychotics trials lasting at least 4 weeks each with a minimum of 400mg chlorpromazine equivalent) DSM-5 diagnosis of schizophrenia or schizoaffective disorder Exclusion Criteria: any change in medication within the past 2 months; substance use disorder within the last 12 months neurological disorder or unstable and serious physical illness ongoing psychotic episode cognitive behavioural therapy for psychosis within the last 12 months

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: Crossover Assignment
Interventional Model Description: Partial crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avatar therapy<br>Immediate Avatar therapy. | Behavioral: Avatar therapy<br>* Patients will receive 6 sessions of avatar therapy consisting of 45 minute (1 session per week). The therapy will consist in prompting patients to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the character of the avatar will progressively become under patients' control. More precisely, the avatar's speech and tone will gradually be changed by the therapist to echo patients' improved ability to regulate their emotions. That is, the avatar will progressively change from being abusive to becoming helpful and supportive. By doing so, the therapy will seek to reinforce patients' feeling of empowerment over their voices.<br>|
| Other: Treatment-as-usual<br>Treatment-as-usual then delayed Avatar therapy. | Behavioral: Avatar therapy<br>* Patients will receive 6 sessions of avatar therapy consisting of 45 minute (1 session per week). The therapy will consist in prompting patients to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the character of the avatar will progressively become under patients' control. More precisely, the avatar's speech and tone will gradually be changed by the therapist to echo patients' improved ability to regulate their emotions. That is, the avatar will progressively change from being abusive to becoming helpful and supportive. By doing so, the therapy will seek to reinforce patients' feeling of empowerment over their voices.<br>Other: Treatment-as-usual<br>* Treatment as usual will consist of typical or atypical antipsychotic medication and regulars appointments with psychiatrists and others care team members for a period of 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Psychotic Symptom Rating Scale - auditory hallucinations | 11-item structured interview assessing the severity of auditory hallucinations | Within 1 week before treatment, within 1 week after treatment, follow-up 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Beliefs About Voices Questionnaire - Revised | 35-item self-report measure designed to assess key beliefs and responses people have concerning their voice | Within 1 week before treatment, within 1 week after treatment, follow-up 3 months | 
| Change in Positive And Negative Syndrome Scale | 30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week | Within 1 week before treatment, within 1 week after treatment, follow-up 3 months | 
| Change in Beck Depression Inventory - II | 21-item self-report measure assessing depression symptoms over the past 2 weeks | Within 1 week before treatment, within 1 week after treatment, follow-up 3 months | 
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short From | 16-item self-report scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning | Within 1 week before treatment, within 1 week after treatment, follow-up 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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auditory hallucination, schizophrenia, treatment-resistant, psychotherapy, virtual reality, avatar