Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia

Treatment-resistant Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148639
• Other study ID #: IPPM 14-006
• Status: Completed
• Phase: N/A
• First received: May 5, 2017
• Last updated: January 28, 2018
• Start date: September 1, 2015
• Est. completion date: December 2, 2017

Study information

• Verified date: January 2018
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Auditory Hallucination, Verbal
• Hallucinations
• Schizophrenia
• Treatment-resistant Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Canada	Institut Universitaire en Santé Mentale de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	Centre de recherche de l'Institut universitaire en santé mentale de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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