Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia

Sponsor

Ciusss de L'Est de l'Île de Montréal (Other)

Overall Status

Completed

CT.gov ID

NCT03148639

Collaborator

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Auditory Hallucination, Verbal Treatment-resistant Schizophrenia	Behavioral: Avatar therapy Other: Treatment-as-usual	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Partial crossover designPartial crossover design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Mar 31, 2017

Actual Study Completion Date :

Dec 2, 2017

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Change in Psychotic Symptom Rating Scale - auditory hallucinations [Within 1 week before treatment, within 1 week after treatment, follow-up 3 months]
11-item structured interview assessing the severity of auditory hallucinations

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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