Clinical trial NCT03148639: Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia
Official title: Emotion Regulation Using Virtual Reality in Schizophrenia: a Clinical and Mechanistic Trial of Avatar Therapy for Refractory Auditory Hallucinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Hallucination, Verbal
Treatment-resistant Schizophrenia
Keywords: auditory hallucination
schizophrenia
treatment-resistant
psychotherapy
virtual reality
avatar
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
First posted: 2017-05-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Partial crossover design
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Psychotic Symptom Rating Scale - auditory hallucinations
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Secondary outcomes:
measure: Change in Beliefs About Voices Questionnaire - Revised
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
measure: Change in Positive And Negative Syndrome Scale
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
measure: Change in Beck Depression Inventory - II
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short From
timeFrame: Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Other outcomes:
measure: Change in Self-reported anxiety, fear and presence
timeFrame: Last 10 min of each therapy session
Locations:
city: Montréal
country: Canada
facility: Institut Universitaire en Santé Mentale de Montréal
state: Quebec
Study officials:
affiliation: Institut Philippe Pinel de Montréal
name: Alexandre Dumais, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: