Avatar Therapy vs Cognitive Behavioral Therapy for Schizophrenia

(Phase3 Trial)

Overseen by Alexandre Dumais, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Must be taking: Antipsychotics

Disqualifiers: Substance use, Neurological, Intellectual, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of medication for the last 2 months before joining, so you should not stop taking your current medications.

What data supports the effectiveness of the treatment Avatar Therapy vs Cognitive Behavioral Therapy for Schizophrenia?

Research shows that Avatar Therapy, which involves interacting with a digital representation of distressing voices, is effective for managing these voices in schizophrenia. Additionally, combining Cognitive Behavioral Therapy with Virtual Reality-Assisted Therapy may improve outcomes for patients with treatment-resistant schizophrenia. ^{1 2 3 4 5}

Is Avatar Therapy and Virtual Reality-Assisted Therapy safe for humans?

Research on Avatar Therapy and Virtual Reality-Assisted Therapy shows they are generally safe and well-accepted by participants, with no significant side effects reported in studies for various conditions, including anxiety and mindfulness practice. ^{5 6 7 8 9}

What makes Avatar Therapy and Cognitive Behavioral Therapy unique for treating schizophrenia?

Avatar Therapy (AT) and Virtual Reality-Assisted Therapy (VRT) are unique because they use virtual reality to create interactive experiences that can help patients with schizophrenia, especially those with treatment-resistant symptoms, by providing a more engaging and personalized approach compared to traditional Cognitive Behavioral Therapy (CBT). These therapies have shown potential for greater improvements in auditory hallucinations and affective symptoms, and they offer a promising future for tailored treatments. ^{1 4 10 11 12}

Research Team

Alexandre Dumais, MD, PhD

Principal Investigator

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I have undergone Cognitive Behavioral Therapy for psychosis in the past year.

I have a neurological disorder.

You are currently having a severe mental episode.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Avatar Therapy or Cognitive Behavioral Therapy over 9 weekly sessions

9 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-ups at 3, 6, and 12 months

Treatment Details

Interventions

• Avatar Therapy (Behavioural Intervention)
• Cognitive Behavioral Therapy (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Avatar Therapy Experimental Treatment 1 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 Therapy Active Control 1 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.

Avatar Therapy is already approved in Canada for the following indications:

Approved in Canada as Avatar Therapy for:

• Chronic auditory hallucinations in schizophrenia

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Sylvain Lemieux

Ciusss de L'Est de l'Île de Montréal

Chief Executive Officer since 2018

Maîtrise en administration publique from ENAP, Certificat en leadership et habiletés de direction from Concordia University, Baccalauréat en service social from Université de Sherbrooke

Dr. Marie-Claude Roy

Ciusss de L'Est de l'Île de Montréal

Chief Medical Officer since 2020

MD from Université de Montréal

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Findings from Research

Participants with psychosis reported significant improvements in managing agoraphobic avoidance after using gameChange VR therapy, particularly those with severe avoidance, highlighting its efficacy as a therapeutic tool.

The immersive VR scenarios allowed users to confront their anxieties in a safe environment, enabling them to learn new coping strategies and gradually apply these skills in real-world situations, suggesting a promising mechanism for anxiety reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. Bond, J., Kenny, A., Pinfold, V., et al.[2023]

Patients and staff expressed strong enthusiasm for the gameChange VR therapy on psychiatric wards, believing it could help build confidence and reduce anxiety as patients prepare for discharge.

The main barrier to implementing VR therapy was the need for sufficient private space, but overall, both patients and staff felt that VR could be integrated into current care with proper support and training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Virtual Reality Cognitive Therapy (gameChange) in Inpatient Psychiatric Wards: Qualitative Study of Staff and Patient Views Using an Implementation Framework. Brown, P., Waite, F., Lambe, S., et al.[2023]

In a study involving 16 patients with treatment-resistant schizophrenia, various emotions were identified during avatar therapy sessions, including anger, joy, and fear, highlighting the emotional dynamics of patient-avatar interactions.

The findings suggest that patients predominantly expressed neutral and joyful emotions, while avatars showed interest and disgust, indicating a complex emotional landscape that could influence the effectiveness of avatar therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of the role of emotional expression of treatment-resistant schizophrenia patients having followed virtual reality therapy: a content analysis. Hudon, A., Lammatteo, V., Rodrigues-Coutlée, S., 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]

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]

Virtual Reality (VR) interventions have been shown to significantly reduce symptoms of various anxiety disorders in adults, making them a promising alternative to traditional exposure therapy.

These VR treatments are generally well-accepted by clients and have minimal side effects, although caution is advised for Combat-Related PTSD in Vietnam veterans, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. Andersen, NJ., Schwartzman, D., Martinez, C., et al.[2023]

Avatar-based virtual reality therapy, specifically using the ProReal software, has shown promise in helping young people engage in therapy, with outcome measures indicating a reduction in mental health difficulties over time.

The two case studies highlighted that ProReal was accessible and effective in helping young users externalize their thoughts and feelings, facilitating better communication with their clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in Practice: Avatar-based virtual reality in CAMHS talking therapy: two exploratory case studies. Falconer, CJ., Davies, EB., Grist, R., et al.[2020]

Virtual reality cognitive-behavior therapy (VRCBT) is as effective as traditional cognitive-behavior therapy (CBT) in reducing public speaking anxiety, with both treatments showing significant improvements compared to a wait-list control group.

Both VRCBT and CBT maintained their treatment gains over a 1-year follow-up, indicating that the benefits of these therapies for public speaking anxiety are durable, with CBT participants continuing to improve in specific anxiety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality cognitive-behavior therapy for public speaking anxiety: one-year follow-up. Safir, MP., Wallach, HS., Bar-Zvi, M.[2018]

A pilot study with 44 mindfulness experts using Virtual Reality (VR) for Dialectical Behavioral Therapy (DBT®) mindfulness training showed significant improvements in state of mindfulness and reductions in negative emotions like sadness, anger, and anxiety.

Participants experienced a strong sense of presence in the VR environment and accepted it as a useful tool for mindfulness practice, suggesting that VR could enhance the accessibility and effectiveness of mindfulness training for those who struggle with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. Navarro-Haro, MV., López-Del-Hoyo, Y., Campos, D., et al.[2023]

This study will compare the effectiveness of virtual reality-based cognitive-behavioral therapy (VRcbt) to standard cognitive-behavioral therapy for psychosis (CBTp) in treating paranoid delusions in 106 patients with psychotic disorders over 8-12 weeks.

The primary outcome will measure changes in paranoid ideations in daily life using ecological momentary assessments, which could demonstrate whether VRcbt is more effective and cost-effective than traditional CBTp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial. Berkhof, M., van der Stouwe, ECD., Lestestuiver, B., et al.[2021]

A randomized controlled trial involving 116 patients with psychotic disorders showed that adding virtual reality-based cognitive behavioral therapy (VR-CBT) to standard treatment significantly improved social participation and reduced paranoid ideation, with a high percentage of participants (90.74%-99.74%) showing improvement.

The cost-effectiveness analysis indicated that VR-CBT is economically viable, with an average cost per treatment responder ranging from €6800 to €16,597 and an average cost per quality-adjusted life year (QALY) gained of €42,030 over six months, suggesting it is a cost-effective intervention for improving health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Virtual Reality Cognitive Behavioral Therapy for Psychosis: Health-Economic Evaluation Within a Randomized Controlled Trial. Pot-Kolder, R., Veling, W., Geraets, C., et al.[2020]

A pilot study involving 74 patients with treatment-resistant schizophrenia found that both virtual reality therapy (VRT) and cognitive-behavioral therapy (CBT) significantly improved symptoms of auditory verbal hallucinations (AVH) and depression, with VRT showing larger effects on overall AVH severity and affective symptoms.

VRT also demonstrated significant improvements in persecutory beliefs and quality of life, with these benefits maintained for up to one year, suggesting that VRT may offer advantages over traditional CBT for treating psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year randomized trial comparing virtual reality-assisted therapy to cognitive-behavioral therapy for patients with treatment-resistant schizophrenia. Dellazizzo, L., Potvin, S., Phraxayavong, K., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Safe Place to Learn: Peer Research Qualitative Investigation of gameChange Virtual Reality Therapy. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Automated Virtual Reality Cognitive Therapy (gameChange) in Inpatient Psychiatric Wards: Qualitative Study of Staff and Patient Views Using an Implementation Framework. [2023]

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

Exploration of the role of emotional expression of treatment-resistant schizophrenia patients having followed virtual reality therapy: a content analysis. [2023]

4. 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]

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

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual reality interventions for the treatment of anxiety disorders: A scoping review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Innovations in Practice: Avatar-based virtual reality in CAMHS talking therapy: two exploratory case studies. [2020]

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

Virtual reality cognitive-behavior therapy for public speaking anxiety: one-year follow-up. [2018]

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

Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Virtual Reality Cognitive Behavioral Therapy for Psychosis: Health-Economic Evaluation Within a Randomized Controlled Trial. [2020]

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

One-year randomized trial comparing virtual reality-assisted therapy to cognitive-behavioral therapy for patients with treatment-resistant schizophrenia. [2023]