Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia
Primary Purpose
Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Avatar therapy
Treatment-as-usual
Sponsored by
About this trial
This is an interventional treatment trial for Auditory Hallucination, Verbal focused on measuring auditory hallucination, schizophrenia, treatment-resistant, psychotherapy, virtual reality, avatar
Eligibility Criteria
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
Sites / Locations
- Institut Universitaire en Santé Mentale de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Avatar therapy
Treatment-as-usual
Arm Description
Immediate Avatar therapy.
Treatment-as-usual then delayed Avatar therapy.
Outcomes
Primary Outcome Measures
Change in Psychotic Symptom Rating Scale - auditory hallucinations
11-item structured interview assessing the severity of auditory hallucinations
Secondary Outcome Measures
Change in Beliefs About Voices Questionnaire - Revised
35-item self-report measure designed to assess key beliefs and responses people have concerning their voice
Change in Positive And Negative Syndrome Scale
30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week
Change in Beck Depression Inventory - II
21-item self-report measure assessing depression symptoms over the past 2 weeks
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
Full Information
NCT ID
NCT03148639
First Posted
May 5, 2017
Last Updated
January 28, 2018
Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT03148639
Brief Title
Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia
Official Title
Emotion Regulation Using Virtual Reality in Schizophrenia: a Clinical and Mechanistic Trial of Avatar Therapy for Refractory Auditory Hallucinations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
December 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborators
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia
Keywords
auditory hallucination, schizophrenia, treatment-resistant, psychotherapy, virtual reality, avatar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Partial crossover design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avatar therapy
Arm Type
Experimental
Arm Description
Immediate Avatar therapy.
Arm Title
Treatment-as-usual
Arm Type
Other
Arm Description
Treatment-as-usual then delayed Avatar therapy.
Intervention Type
Behavioral
Intervention Name(s)
Avatar therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment-as-usual
Intervention Description
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 Outcome Measure Information:
Title
Change in Psychotic Symptom Rating Scale - auditory hallucinations
Description
11-item structured interview assessing the severity of auditory hallucinations
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Secondary Outcome Measure Information:
Title
Change in Beliefs About Voices Questionnaire - Revised
Description
35-item self-report measure designed to assess key beliefs and responses people have concerning their voice
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Title
Change in Positive And Negative Syndrome Scale
Description
30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Title
Change in Beck Depression Inventory - II
Description
21-item self-report measure assessing depression symptoms over the past 2 weeks
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Title
Change in Quality of Life Enjoyment and Satisfaction Questionnaire - Short From
Description
16-item self-report scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning
Time Frame
Within 1 week before treatment, within 1 week after treatment, follow-up 3 months
Other Pre-specified Outcome Measures:
Title
Change in Self-reported anxiety, fear and presence
Description
3-item self-report scale, ranging from 0 (no emotion) to 10 (strongest emotion)
Time Frame
Last 10 min of each therapy session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, Ph.D
Organizational Affiliation
Institut Philippe Pinel de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Universitaire en Santé Mentale de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia
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