Skip to main content
OpenTrials
Completed

NCT Number: NCT03148639

Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Auditory Hallucination, Verbal Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant Signs and Symptoms Treatment-resistant Schizophrenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire en Santé Mentale de Montréal

Montreal, Quebec, H1N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Psychotic Symptom Rating Scale - auditory hallucinations

    Time frame: 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 outcomes

  1. Change in Beliefs About Voices Questionnaire - Revised

    Time frame: 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

  2. Change in Positive And Negative Syndrome Scale

    Time frame: 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

  3. Change in Beck Depression Inventory - II

    Time frame: 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

  4. Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short From

    Time frame: 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 outcomes

  1. Change in Self-reported anxiety, fear and presence

    Time frame: Last 10 min of each therapy session

    3-item self-report scale, ranging from 0 (no emotion) to 10 (strongest emotion)

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Collaborators

  • Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 11, 2017
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.