Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia

Not Applicable

Completed

• Conditions: Auditory Hallucination, Verbal; Treatment-resistant Schizophrenia
• Interventions: Behavioral: Avatar therapy; Other: Treatment-as-usual

• Registration Number: NCT03148639
• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2017-03-31
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-11
• Study Completion: 2017-12-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-28
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Avatar therapy	Avatar therapy	Immediate Avatar therapy.
Treatment-as-usual	Treatment-as-usual	Treatment-as-usual then delayed Avatar therapy.
Treatment-as-usual	Avatar therapy	Treatment-as-usual then delayed Avatar therapy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Institut Universitaire en Santé Mentale de Montréal; 🇨🇦 Montréal, Quebec, Canada