Auditory Hallucination, VerbalPhase3NCT04054778
Comparaison of Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations
A study testing Avatar Therapy and Cognitive Behavioral Therapy in people with Auditory Hallucination, Verbal and Treatment-resistant Schizophrenia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auditory Hallucination, Verbal, Treatment-resistant Schizophrenia
- What is being tested?
- Avatar Therapy and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche de l'Institut universitaire en santé mentale de Montréal
Montreal, Quebec, H1N3J4
Kingsada Phraxayavong, FSA, FICA, 514-251-4000 ext. 3925, kingsada.phraxayavong@gmail.com
Alexandre Dumais, MD, PhD, 514-251-4000 ext. 3925, alexandre.dumais@umontreal.ca
About this study
Official title: 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.
Read the 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.
- Being tested
- Avatar Therapy, Cognitive Behavioral Therapy
- Keywords
- Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality
- Medical subject headings
- Hallucinations, Schizophrenia, Treatment-Resistant, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatar TherapyBehavioural
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.
Cognitive Behavioral TherapyBehavioural
Also called CBT for psychosis
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.
| Study group | Role | What they receive |
|---|---|---|
| Avatar Therapy | Experimental | 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. Receives: Behavioral: Avatar Therapy |
| Cognitive Behavioral Therapy | Active comparator | 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. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations
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
Measured: Within 1 week after treatment (compared with 1 week before treatment)
Secondary outcomes (7)
Change in the Beliefs About Voices Questionnaire - Revised
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
Measured: 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
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
Measured: 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
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)
Measured: 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
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
Measured: 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
Quality of life scale: 21-item semi-structured scale measuring quality of life (0-126); higher score = better quality of life
Measured: 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
Igroup Presence Questionnaire: 14-item scale measuring the sense of presence; higher score = better presence
Measured: During the therapy (at the end of the first and last session of Avatar Therapy)
Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations
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
Measured: Follow-ups at 3 months, 6 months and 12 months (compared with 1 week before treatment and with 1 week after treatment))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Hallucination, VerbalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will be randomized to receive either TA or CBTp.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Alexandre Dumais, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Alexandre Dumais, MD, PhD, Principal investigator, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054778
- Sponsor's protocol ID
- MP-12-2019-1726
- Acronym
- Phase3
- Status last verified
- Feb 2024
- First submitted
- 19 Jun 2019
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations
- ClinicalTrials.gov ID
- NCT04054778
- Acronym / sponsor ID
- Phase3 / MP-12-2019-1726
- Keywords
- Auditory verbal hallucinations, Schizophrenia, Treatment-resistant, Psychotherapy, Cognitive Behavioral Therapy, Avatar Therapy, Virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will be randomized to receive either TA or CBTp.
| Arm | Type | Receives |
|---|---|---|
| Avatar Therapy | Experimental | Behavioral: Avatar TherapyParticipants 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. |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Substance use disorder within the last 12 months
- Neurological disorder
- Intellectual disability
- Unstable and serious physical illnesses
- Experiencing an acute psychotic episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatar TherapyParticipants 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. | Behavioural | Avatar Therapy |
| Cognitive Behavioral TherapyAlso: CBT for psychosisParticipants 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. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
Change in Igroup Presence Questionnaire
Time frame: 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))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Dumais, MD, PhD principal investigator
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avatar Therapy and Cognitive Behavioral Therapy in people with Auditory Hallucination, Verbal and Treatment-resistant Schizophrenia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Dumais, MD, PhD (514-251-4000 ext. 3925, alexandre.dumais@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Psychotic Symptom Rating Scale - Auditory Hallucinations (time frame: Within 1 week after treatment (compared with 1 week before treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.