Avatar Therapy vs Supportive Care for Cannabis Use in Psychotic Disorders

(AC2 Trial)

Overseen By Alexandre Dumais, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Neurological disorders, Severe illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving ongoing treatment for cannabis use disorder, you may not be eligible to participate.

What data supports the effectiveness of the treatment Avatar Therapy vs Supportive Care for Cannabis Use in Psychotic Disorders?

A pilot study showed that avatar intervention, which uses virtual reality and therapeutic techniques like cognitive behavioral methods, led to a moderate reduction in cannabis use among participants with both severe mental disorders and cannabis use disorder. This suggests that integrating virtual reality into therapy could be promising for reducing cannabis use. ^{1 2 3 4 5}

Is Avatar Therapy safe for use in humans?

Avatar Therapy, including its use in virtual reality treatments, is generally considered safe for adults and people with mental health issues, as long as risks like relapse and trauma are managed. It has been used in treating conditions like anxiety, phobias, and auditory hallucinations, with no major safety concerns reported. ^{1 3 4 6 7}

How is Avatar Therapy different from other treatments for cannabis use in psychotic disorders?

Avatar Therapy is unique because it uses virtual reality to create an immersive experience where participants interact with an avatar representing a significant person related to their drug use, allowing them to practice therapeutic techniques in real-time. This approach combines elements from existing therapies like cognitive behavioral methods and motivational interviewing, offering a novel way to address cannabis use disorder in individuals with severe mental disorders. ^{1 3 4 5 8}

Research Team

Stephane Potvin, PhD

Principal Investigator

University of Montreal, Institut universitaire en santé mentale de Montréal

Emmanuel Stip, MD, MSc

Principal Investigator

United Arab Emirates University

Luigi De Benedictis, MD

Principal Investigator

Institut universitaire en santé mentale de Montréal

Alexandre Dumais, MD, PhD

Principal Investigator

University of Montreal, Institut universitaire en santé mentale de Montréal

Amal Abdel Baki, MD, MSc

Principal Investigator

University of Montreal, Centre hospitalier de l'Université de Montréal

Robert-Paul Juster, PhD

Principal Investigator

University of Montreal, Institut universitaire en santé mentale de Montréal

Marie-Hélène Goulet, PhD

Principal Investigator

University of Montreal, Institut universitaire en santé mentale de Montréal

Eligibility Criteria

This trial is for adults over 18 with schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms who also have a cannabis use problem. They must not be currently treated for other substance use disorders, detoxing from cannabis, have neurological issues or severe physical illnesses.

Inclusion Criteria

I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms.

Exclusion Criteria

Current SUD for a substance other than cannabis

Ongoing pharmacological or psychological treatment for CUD

Ongoing detoxification for cannabis withdrawal

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Avatar Intervention or Addiction Supportive Intervention over 8 weeks, with one session per week and optional additional sessions

8 weeks

8-12 visits (in-person)

Follow-up

Participants are monitored for changes in cannabis use, disorder severity, and quality of life at multiple intervals post-treatment

12 months

Follow-ups at 3, 6, and 12 months

Treatment Details

Interventions

• Addiction supportive intervention
• Avatar Intervention

Trial Overview The study is testing if an 'Avatar Intervention' is more effective than standard supportive care in helping people with psychotic disorders reduce their cannabis use. Participants are randomly assigned to one of the two interventions without knowing which one they're getting.

Participant Groups

Group I: Avatar Intervention Experimental Treatment 1 Intervention

The Avatar Intervention will take place over 8 consecutive weeks, with one session per week. Additional sessions (up to a maximum of 4 sessions) will be offered if needed. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use with the use of virtual reality and avatars.

Group II: Addiction supportive intervention Active Control 1 Intervention

The Addiction supportive intervention will take place over 8 consecutive weeks, with one session per week. Additional sessions (up to a maximum of 4 sessions) will be offered if needed. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use.

Addiction supportive intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Supportive Intervention for:

• Substance Use Disorders
• Addiction Treatment

Approved in European Union as Addiction Counseling for:

• Substance Abuse
• Psychological Disorders

Approved in Canada as Therapeutic Intervention for:

• Addiction Recovery
• Mental Health Disorders

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

A pilot clinical trial involving 19 participants with cannabis use disorder and severe mental disorder showed that an innovative avatar intervention led to a significant moderate reduction in cannabis use, with a Cohen's d of 0.611, indicating effectiveness.

The intervention utilized immersive virtual reality techniques, allowing participants to practice therapeutic methods in real-time, suggesting that this novel approach could enhance treatment outcomes for cannabis use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study. Giguère, S., Potvin, S., Beaudoin, M., et al.[2023]

Combining cognitive behavioral therapy (CBT) with virtual reality-assisted therapy (VRT) showed significant improvements in symptoms for treatment-resistant schizophrenia patients, particularly in auditory hallucinations and depressive symptoms.

The study, involving 10 participants who had previously undergone CBT, suggests that the combination of CBT and VRT may have a synergistic effect, leading to greater improvements than either therapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Benefits of Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy for Auditory Hallucinations in Patients with Treatment-Resistant Schizophrenia: A Proof of Concept. Dellazizzo, L., Potvin, S., Phraxayavong, K., et al.[2023]

This study aims to evaluate the effectiveness of combining cognitive behavioral therapy (CBT) with virtual reality exposure therapy (VRET) for preventing smoking relapse, with 120 participants (60 in each group) over a 14-month period.

The primary outcome will measure tobacco abstinence at 6 months post-therapy, potentially demonstrating that VRET can enhance the effectiveness of traditional CBT in relapse prevention, which could lead to easier implementation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial. Giovancarli, C., Malbos, E., Baumstarck, K., et al.[2018]

AVATAR therapy significantly reduced the severity of persistent auditory verbal hallucinations compared to supportive counselling, with a mean difference in scores indicating a large effect size after 12 weeks of treatment in a study involving 150 participants.

No adverse events were reported for either AVATAR therapy or supportive counselling, suggesting that AVATAR therapy is a safe intervention for individuals experiencing these hallucinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Craig, TK., Rus-Calafell, M., Ward, T., et al.[2019]

Avatar therapy (AT) for treatment-resistant schizophrenia involves patients interacting with an Avatar that represents their auditory hallucinations, revealing important therapeutic dynamics.

Analysis of 256 interactions from 32 patients identified five key dyadic interactions that occurred frequently, suggesting that these dynamics may play a crucial role in the effectiveness of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Interactions of Treatment-Resistant Schizophrenia Patients Having Followed Virtual Reality Therapy: A Content Analysis. Hudon, A., Couture, J., Dellazizzo, L., et al.[2023]

AVATAR therapy is an innovative treatment that allows individuals to engage in face-to-face dialogue with a digital avatar representing their distressing voices, showing promise in addressing these experiences.

This article provides a comprehensive overview of the therapy's delivery, therapeutic targets, acceptability, and potential side effects, highlighting its growing interest and importance for future research and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVATAR Therapy for Distressing Voices: A Comprehensive Account of Therapeutic Targets. Ward, T., Rus-Calafell, M., Ramadhan, Z., et al.[2023]

Practitioners and researchers believe that Virtual Reality Therapy (VRT) could be a valuable addition to treating Substance Use Disorders (SUDs), as it offers safe and realistic exposure to triggering scenarios.

VRT is seen as beneficial for adults and those with mental health issues, with the potential to enhance therapy by allowing the inclusion of avatars and observing reactions, although risks like relapse and over-confidence need to be managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of Practitioners and Researchers on the Use of Virtual Reality in Treatments for Substance Use Disorders. Skeva, R., Gregg, L., Jay, C., et al.[2021]

A twelve-week intervention targeting both cannabis use disorders (CUD) and tobacco smoking showed that all six participants completed the cannabis treatment, and five achieved abstinence from cannabis, indicating that simultaneous treatment can be effective for cannabis outcomes.

While participation in the tobacco intervention was high, with 50% of participants starting nicotine replacement therapy, the actual quit attempts for tobacco were lower than expected, suggesting that more effective strategies are needed to improve tobacco cessation rates alongside CUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series. Lee, DC., Budney, AJ., Brunette, MF., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring the Benefits of Virtual Reality-Assisted Therapy Following Cognitive-Behavioral Therapy for Auditory Hallucinations in Patients with Treatment-Resistant Schizophrenia: A Proof of Concept. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Dyadic Interactions of Treatment-Resistant Schizophrenia Patients Having Followed Virtual Reality Therapy: A Content Analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

AVATAR Therapy for Distressing Voices: A Comprehensive Account of Therapeutic Targets. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Views of Practitioners and Researchers on the Use of Virtual Reality in Treatments for Substance Use Disorders. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series. [2021]