What side effects are associated with this type of intervention?

Common treatments for schizophrenia, such as antipsychotic medications, often cause side effects including extrapyramidal symptoms (EPS), weight gain, metabolic syndrome, and sedation. Innovative treatments like Cognitive Behavioral Therapy (CBT) and Virtual Reality (VR) therapies, including Avatar Therapy, typically have fewer physical side effects but may lead to psychological discomforts such as anxiety, panic, or difficulties concentrating during sessions.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including clozapine, risperidone, quetiapine, and aripiprazole. These drugs are effective in reducing symptoms such as hallucinations and delusions. Cognitive Behavioral Therapy (CBT) is also used, though it offers only moderate benefits. Avatar Therapy, a novel approach involving engagement with a virtual representation of distressing voices to help patients control their auditory hallucinations, is currently under study and not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to Avatar Therapy for schizophrenia patients include: 1) Cognitive Behavioral Therapy (CBT) with virtual reality (VR) enhancements, which uses immersive VR to create controlled environments for patients to confront and manage their hallucinations. 2) Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation technique that has shown potential in reducing auditory hallucinations by modulating neural activity. 3) Neurofeedback, which involves training patients to alter their brain activity patterns through real-time feedback, potentially reducing the frequency and intensity of hallucinations.

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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

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological disorder.

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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))

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

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 more

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 / 5Eligibility criteria met

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.