- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04054778
Comparaison of Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations (Phase3)
February 5, 2024 updated by: Alexandre Dumais, Ciusss de L'Est de l'Île de Montréal
A Randomized Controlled Trial Comparing Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations
Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society.
According to the World Health Organization, this burdensome illness is one of the top 10 causes of disability in developed countries.
The costs associated with hospitalization, lifelong treatment and loss of productivity lead to a great economic burden.
In Canada, the total annual costs associated with schizophrenia are over $10 billion.
The main reason for this heavy burden is that 25-30% of schizophrenia patients respond very poorly to antipsychotic medication.
Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population.
This unmet clinical need requires innovation and action.
Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) are very limited and provide at best moderate results.
Virtual reality (VR) opens new exciting avenues to treat this illness.
With immersive VR, our team recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of their distressing voice.
This relational and experiential approach offers a unique opportunity to help patients gain control over their voice.
The preliminary results of our randomized-controlled trial (RCT) pilot showed a large effect on auditory verbal hallucination for AT and a moderate effect for CBT.
The main goal of the currently proposed RCT study will be to examine if AT is superior to CBT for the treatment of chronic auditory hallucinations in schizophrenia.
As evidence-based therapeutic options are limited for this burdensome illness and provide only modest symptomatic relief, the current trial will contribute to the validation of a novel approach answering a fundamental clinical need.
The demonstration of the superior efficacy of AT would be a great breakthrough and will open new avenues to clinical treatment.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society.
According to the World Health Organization, this burdensome illness is one of the top 10 causes of disability in developed countries.
The costs associated with hospitalization, lifelong treatment and loss of productivity lead to a great economic burden.
In Canada, the total annual costs associated with schizophrenia are over $10 billion.
The main reason for this heavy burden is that 25-30% of schizophrenia patients respond very poorly to antipsychotic medication.
Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population.
This unmet clinical need requires innovation and action.
Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) provide at best moderate results.
Using immersive virtual reality, our team recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of the patient's distressing voice.
This approach, being both relational and experiential, provides a unique opportunity to aid patients gain control over their voice.
The results of our pilot study on AT were clinically promising for the severity and distress related to hallucinations, positive symptomatology and emotion regulation.
The preliminary results of our small pilot randomized-controlled trial showed a large effect of AT on auditory verbal hallucination, while a moderate effect was found for our adapted short CBT for hallucinations.
To further research in this field, the primary goal of this single-blinded randomized-controlled, single-site parallel study is to show that AT is superior to CBT for the treatment of persistent auditory hallucinations in schizophrenia.
The secondary goal is to examine the effects of these interventions on emotion regulation, mood symptoms (anxiety and depression), self-esteem, level of functioning and quality of life.
To do so, each treatment group will include 68 participants over 18 years of age hearing persecutory voices and suffering from treatment resistant schizophrenia or schizoaffective disorder.
AT comprises of 9 weekly sessions: 1 avatar creation session and 8 therapeutic sessions, where the patients are confronted to their reproduced hallucinatory experience and are encouraged to enter in a dialogue with their virtual persecutor.
CBT includes 9 weekly sessions consisting of learning modules and task assignments.
Subjects will be evaluated at pre- and post-treatment.
Follow-ups will be ensured at 3, 6 and 12 months to assess primary (auditory hallucination) and secondary outcomes.
Mixed model analyses will be performed to measure and compare the effects of both interventions.
As evidence-based therapeutic options are limited for this burdensome illness and provide only modest symptomatic relief, the current trial will contribute to the validation of a novel approach answering a fundamental clinical need.
Ultimately, the demonstration of the superior efficacy of AT would be a great breakthrough and will open new avenues to clinical treatment.
Study Type
Interventional
Enrollment (Estimated)
136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexandre Dumais, MD, PhD
- Phone Number: 3925 514-251-4000
- Email: alexandre.dumais@umontreal.ca
Study Contact Backup
- Name: Stéphane Potvin, PhD
- Phone Number: 2851 514-251-4015
- Email: stephane.potvin@umontreal.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H1N3J4
- Recruiting
- Centre de recherche de l'Institut universitaire en santé mentale de Montréal
-
Contact:
- Alexandre Dumais, MD, PhD
- Phone Number: 3925 514-251-4000
- Email: alexandre.dumais@umontreal.ca
-
Contact:
- Kingsada Phraxayavong, FSA, FICA
- Phone Number: 3925 514-251-4000
- Email: kingsada.phraxayavong@gmail.com
-
Principal Investigator:
- Alexandre Dumais, MD, PhD
-
Principal Investigator:
- Stephane Potvin, PhD
-
Sub-Investigator:
- Kieron O'Connor, PhD, FCPA
-
Sub-Investigator:
- Emmanuel Stipp, MD, MSc
-
Sub-Investigator:
- Marie-Hélène Goulet, Inf., PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- DSM-5 diagnosis of schizophrenia or schizoaffective disorder
- Distressing auditory verbal hallucinations
- Did not respond to 2 antipsychotic trials
- Stable doses of medication during the last 2 months prior to enrollment
Exclusion Criteria:
- Substance use disorder within the last 12 months
- Neurological disorder
- Intellectual disability
- Unstable and serious physical illnesses
- Experiencing an acute psychotic episode
- Cognitive Behavioral Therapy for psychosis within the last 12 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Avatar Therapy
Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist experienced with psychosis patients.
The therapy will consist in prompting participants to enter in a dialogue with their persecutor to better regulate their emotional responses.
Over the course of the therapy, the avatar's speech and tone will gradually be changed by the therapist to echo participants' 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 participants' feeling of empowerment over their voices.
|
Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist experienced with psychosis patients.
The therapy will consist in prompting participants to enter in a dialogue with their persecutor to better regulate their emotional responses.
Over the course of the therapy, the avatar's speech and tone will gradually be changed by the therapist to echo participants' 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 participants' feeling of empowerment over their voices.
|
Active Comparator: Cognitive Behavioral Therapy
Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist trained in Cognitive Behavioral Therapy for psychosis (CBTp).
The program is derived and adapted from current evidence-based treatments for hallucinations.
The 9 CBTp sessions will consist of a succession of learning modules and suggested task assignments.
|
Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist trained in Cognitive Behavioral Therapy for psychosis (CBTp).
The program is derived and adapted from current evidence-based treatments for hallucinations.
The 9 CBTp sessions will consist of a succession of learning modules and suggested task assignments.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations
Time Frame: Within 1 week after treatment (compared with 1 week before treatment)
|
Psychotic Symptom Rating Scale - Auditory Hallucinations: 11-item structured interview assessing the severity of auditory hallucinations (scale 0-44); Subscales: Frequency (0-12), Distress (0-20); higher values = worse
|
Within 1 week after treatment (compared with 1 week before treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Beliefs About Voices Questionnaire - Revised
Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Beliefs About Voices Questionnaire - Revised: 35-item self-report measure designed to assess key beliefs and responses people have concerning their voice (0-105); Subscales: Malevolence (0-18), Omnipotence (0-18), Benevolence (0-18); higher scores = worse
|
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Change in the Positive And Negative Syndrome Scale
Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Positive And Negative Syndrome Scale: 30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week; Subscales: Positive (7-49), Negative (7-49), General (16-112), Total score (subscales summed; 30-210); higher values = worse symptomatology
|
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Change in the Calgary Depression Scale for schizophrenia
Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Calgary Depression Scale for schizophrenia: 9-item semi-structured scale to assess the level of depression in schizophrenia (total score range: 0-27; higher values = worse depressive symptoms)
|
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form: 16-item self-report scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning (16-80); higher values = better
|
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Change in the Quality of life scale
Time Frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Quality of life scale: 21-item semi-structured scale measuring quality of life (0-126); higher score = better quality of life
|
Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
|
Change in Igroup Presence Questionnaire
Time Frame: During the therapy (at the end of the first and last session of Avatar Therapy)
|
Igroup Presence Questionnaire: 14-item scale measuring the sense of presence; higher score = better presence
|
During the therapy (at the end of the first and last session of Avatar Therapy)
|
Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations
Time Frame: Follow-ups at 3 months, 6 months and 12 months (compared with 1 week before treatment and with 1 week after treatment))
|
Psychotic Symptom Rating Scale - Auditory Hallucinations: 11-item structured interview assessing the severity of auditory hallucinations; Subscales: Frequency (0-12), Distress (0-20); higher score = worse
|
Follow-ups at 3 months, 6 months and 12 months (compared with 1 week before treatment and with 1 week after treatment))
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alexandre Dumais, MD, PhD, Centre de recherche de l'Institut universitaire en santé mentale de Montréal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
June 19, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 13, 2019
Study Record Updates
Last Update Posted (Actual)
February 6, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-12-2019-1726
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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