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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

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

Phase3 Trial Summary

This trial will test if a new psychotherapeutic intervention, Avatar Therapy (AT), is more effective than Cognitive Behavior Therapy (CBT) for treating auditory hallucinations in people with schizophrenia.

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.Check my eligibility

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.See study design

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.

Phase3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with schizophrenia or schizoaffective disorder.

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I did not improve after trying two different antipsychotic medications.

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I hear voices that cause me distress.

Phase3 Trial 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))

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-ups at 3 months, 6 months and 12 months (compared with 1 week before treatment and with 1 week after treatment)) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in Igroup Presence Questionnaire

Change in the Beliefs About Voices Questionnaire - Revised

Change in the Calgary Depression Scale for schizophrenia

+4 more

Phase3 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

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor

71 Previous Clinical Trials

5,425 Total Patients Enrolled

2 Trials studying Schizophrenia

93 Patients Enrolled for Schizophrenia

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,348 Previous Clinical Trials

26,455,572 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment capacity of this trial?

"Indeed, the current records from clinicaltrials.gov assert that this research is actively recruiting volunteers. The trial was first listed on April 1st 2019 and it's still recruitment period has been recently renewed to November 8th 2022. A total of 136 subjects need to be enrolled at one medical centre."

Answered by AI

Is registration currently open for this medical experiment?

"That is correct. According to information hosted on clinicaltrials.gov, this trial was initially posted in April of 2019 and has been actively seeking participants since then. 136 patients are needed from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparaison of Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations

Alexandre Dumais 2019. "Comparaison of Avatar Therapy to Cognitive Behavioral Therapy in Schizophrenia With Treatment Refractory Hallucinations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04054778.