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Avatar Therapy vs Cognitive Behavioral Therapy for Schizophrenia (Phase3 Trial)
N/A
Recruiting
Led By Alexandre Dumais, MD, PhD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DSM-5 diagnosis of schizophrenia or schizoaffective disorder
Did not respond to 2 antipsychotic trials
Must not have
Neurological disorder
Unstable and serious physical illnesses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-ups at 3 months, 6 months and 12 months (compared with 1 week before treatment and with 1 week after treatment))
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment called Avatar Therapy (AT) for people with schizophrenia who hear distressing voices and don't respond well to regular medications. AT uses virtual reality to help patients talk to a digital version of their troubling voice. The goal is to see if AT works better in reducing these hallucinations and improving overall well-being.
Who is the study for?
This trial is for individuals with schizophrenia or schizoaffective disorder who hear distressing voices and haven't improved after trying two different antipsychotic medications. They should be on a stable medication dose for the last 2 months. People with recent substance use issues, neurological disorders, intellectual disabilities, serious physical illnesses, or those who've had CBT for psychosis in the past year can't join.
What is being tested?
The study compares Avatar Therapy (AT), where patients interact with a virtual representation of their hallucinations, to Cognitive Behavioral Therapy (CBT). It aims to see if AT is more effective than CBT in treating persistent auditory hallucinations in schizophrenia.
What are the potential side effects?
While not drug treatments, both therapies may cause emotional discomfort due to confronting hallucinations or challenging thoughts. Participants might experience increased anxiety or stress during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia or schizoaffective disorder.
Select...
I did not improve after trying two different antipsychotic medications.
Select...
I hear voices that cause me distress.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neurological disorder.
Select...
I do not have any serious or unstable illnesses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow-ups at 3 months, 6 months and 12 months (compared with 1 week before treatment and with 1 week after treatment))
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-ups at 3 months, 6 months and 12 months (compared with 1 week before treatment and with 1 week after treatment))
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in Igroup Presence Questionnaire
Change in the Beliefs About Voices Questionnaire - Revised
Change in the Calgary Depression Scale for schizophrenia
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Avatar TherapyExperimental Treatment1 Intervention
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.
Group II: Cognitive Behavioral TherapyActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avatar Therapy
2021
N/A
~90
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for schizophrenia include antipsychotic medications, cognitive-behavioral therapy (CBT), and emerging therapies like Avatar Therapy. Antipsychotic medications primarily work by blocking dopamine receptors, which helps reduce psychotic symptoms such as hallucinations and delusions.
CBT helps patients by challenging and changing unhelpful cognitive distortions and behaviors, improving emotional regulation, and developing personal coping strategies. Avatar Therapy, an innovative approach, involves patients engaging with a virtual representation of their distressing voices, which helps them gain control over these auditory hallucinations.
These treatments are crucial as they address both the neurochemical imbalances and the psychological aspects of schizophrenia, thereby improving overall functioning and quality of life for patients.
Immersive Virtual Reality Applications in Schizophrenia Spectrum Therapy: A Systematic Review.[Diagnosis and treatment of motor phenomena in schizophrenia spectrum disorders].Preferences for psychological therapy in psychosis: trial participation, mode of treatment, and willingness to be randomised.
Immersive Virtual Reality Applications in Schizophrenia Spectrum Therapy: A Systematic Review.[Diagnosis and treatment of motor phenomena in schizophrenia spectrum disorders].Preferences for psychological therapy in psychosis: trial participation, mode of treatment, and willingness to be randomised.
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Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
78 Previous Clinical Trials
6,279 Total Patients Enrolled
2 Trials studying Schizophrenia
93 Patients Enrolled for Schizophrenia
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,529,309 Total Patients Enrolled
13 Trials studying Schizophrenia
727,436 Patients Enrolled for Schizophrenia
Alexandre Dumais, MD, PhDPrincipal InvestigatorCentre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
2 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone Cognitive Behavioral Therapy for psychosis in the past year.I have been diagnosed with schizophrenia or schizoaffective disorder.I did not improve after trying two different antipsychotic medications.My medication doses have been the same for the last 2 months.I hear voices that cause me distress.I have a neurological disorder.You are currently having a severe mental episode.I do not have any serious or unstable illnesses.You have struggled with drug or alcohol addiction in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Avatar Therapy
- Group 2: Cognitive Behavioral Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.