Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia

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

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.

Study Overview

• Status: Completed
• Conditions: Treatment-resistant Schizophrenia; Auditory Hallucination, Verbal
• Intervention / Treatment: Behavioral: Avatar therapy; Other: Treatment-as-usual

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1N 3M5
      • Institut Universitaire en Santé Mentale de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avatar therapy; Immediate Avatar therapy.	Behavioral: Avatar therapy; 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.
Other: Treatment-as-usual; Treatment-as-usual then delayed Avatar therapy.	Behavioral: Avatar therapy; 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.; Other: Treatment-as-usual; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-reported anxiety, fear and presence	3-item self-report scale, ranging from 0 (no emotion) to 10 (strongest emotion)	Last 10 min of each therapy session

Collaborators and Investigators

• Sponsor: Ciusss de L'Est de l'Île de Montréal
• Collaborators: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
• Investigators: Principal Investigator: Alexandre Dumais, MD, Ph.D, Institut Philippe Pinel de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): December 2, 2017

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 28, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: schizophrenia; psychotherapy; virtual reality; auditory hallucination; treatment-resistant; avatar
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Schizophrenia; Hallucinations
• Other Study ID Numbers: IPPM 14-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No