Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia

NCT03148639 | Completed

• 1 other identifier: IPPM 14-006
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Auditory Hallucination, Verbal; Treatment-resistant Schizophrenia

Keywords

auditory hallucination; schizophrenia; treatment-resistant; psychotherapy; virtual reality; avatar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Beliefs About Voices Questionnaire - Revised

  Within 1 week before treatment, within 1 week after treatment, follow-up 3 months

• Change in Positive And Negative Syndrome Scale

  Within 1 week before treatment, within 1 week after treatment, follow-up 3 months

• Change in Beck Depression Inventory - II

  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

  Within 1 week before treatment, within 1 week after treatment, follow-up 3 months

Other Outcomes (1)

• Change in Self-reported anxiety, fear and presence

  Last 10 min of each therapy session

Study Arms (2)

Avatar therapy

EXPERIMENTAL

Immediate Avatar therapy.

Behavioral: Avatar therapy

Treatment-as-usual

OTHER

Treatment-as-usual then delayed Avatar therapy.

Behavioral: Avatar therapy; Other: Treatment-as-usual

Interventions

Avatar therapy BEHAVIORAL

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.

Avatar therapy; Treatment-as-usual

Treatment-as-usual OTHER

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.

Treatment-as-usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal: collaborator

Study Sites (1)

Institut Universitaire en Santé Mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

Location

MeSH Terms

Conditions

Hallucinations; Schizophrenia, Treatment-Resistant; Schizophrenia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Alexandre Dumais, MD, Ph.D

  Institut Philippe Pinel de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, researcher

Model Details: Partial crossover design

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 11, 2017
• Study Start: September 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: December 2, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)