Avatar Therapy vs Cognitive Behavioral Therapy for Schizophrenia

(Phase3 Trial)

Recruiting at 1 trial location

Overseen By Stéphane Potvin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Must be taking: Antipsychotics

Disqualifiers: Substance use, Neurological, Intellectual, others

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

Compensation: Varies

Number of Visits: 12

Duration: 9 weeks

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two therapies for individuals with schizophrenia who hear distressing voices unresponsive to regular medication. One treatment, Avatar Therapy, involves patients conversing with a virtual character representing their troubling voice to help them gain control. The other, Cognitive Behavioral Therapy, involves discussing thoughts and behaviors in structured sessions. The trial seeks participants with schizophrenia or schizoaffective disorder who hear distressing voices and haven't improved with at least two different antipsychotic medications. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could enhance quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Avatar Therapy is generally well-tolerated by people with schizophrenia. This treatment uses virtual reality to reduce troubling auditory hallucinations without significant side effects. In earlier studies, participants reported feeling more empowered and in control of their symptoms after Avatar Therapy sessions.

Cognitive Behavioral Therapy (CBT) is also considered safe and is commonly used to treat various mental health issues, including schizophrenia. Although serious side effects are rare, the therapy requires active participation and can sometimes be challenging.

Both treatments are designed to be safe and effective, with research supporting their tolerability for people with schizophrenia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional therapies for schizophrenia, which often focus on managing symptoms through medication and conventional therapy, Avatar Therapy offers a unique approach by using a virtual avatar to help patients engage directly with their hallucinations. The therapy is designed to empower individuals by allowing them to converse with a digital representation of their persecutor, which gradually transforms from hostile to supportive as the patient's emotional regulation improves. This interactive and personalized method aims to enhance patients' control over their hallucinations, potentially leading to significant improvements in their overall quality of life. Researchers are excited about Avatar Therapy because it represents a novel and promising avenue for addressing the emotional and psychological aspects of schizophrenia in a way that conventional treatments do not.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

This trial will compare Avatar Therapy (AT) with Cognitive Behavioral Therapy (CBT) for schizophrenia. Research has shown that Avatar Therapy, one of the treatments participants may receive, yields promising results for people with schizophrenia. In a previous study, AT significantly reduced the severity of auditory hallucinations, the distressing voices patients hear. This therapy uses virtual reality to help patients feel more in control of these voices. In contrast, Cognitive Behavioral Therapy, another treatment option in this trial, has shown a small to medium effect on improving symptoms like hallucinations and delusions in schizophrenia. A review of several studies estimated the impact of CBT on these symptoms at 0.31, considered moderate. Overall, both treatments offer potential benefits, but initial findings suggest that AT might have a stronger impact on reducing auditory hallucinations. ^{1 2 3 4 5}

Who Is on the Research Team?

Alexandre Dumais, MD, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

I do not have any serious or unstable illnesses.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Avatar Therapy
• Cognitive Behavioral Therapy

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.

How Is the Trial Designed?

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 United Kingdom, Canada for the following indications:

Approved in United Kingdom as Avatar Therapy for:

• Treatment-resistant schizophrenia with auditory hallucinations

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+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12007037/

AVATAR Virtual Reality Social therapy (AVATAR_VRSocial ... Compared with TAU, AVATAR_VRSocial therapy added to usual care will reduce total voice severity, reduce psychiatric symptoms (depression, ...

2. nature.com nature.com/articles/s41591-024-03252-8

Digital AVATAR therapy for distressing voices in psychosis The primary outcome was voice-related distress at both time points, while voice severity and voice frequency were key secondary outcomes. Voice- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2215036625001610

Articles Immersive virtual reality-assisted therapy targeting ... Our findings showed that Challenge-VRT was significantly more effective than enhanced treatment-as- usual in reducing the severity of auditory hallucinations in ...

4. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06683-1

the effects of a virtual reality-assisted exposure therapy ... - Trials The aim of this trial is to examine the effect of a targeted virtual reality therapy for persistent auditory hallucinations in individuals with psychosis.

5. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(25)00161-0/abstract

the Challenge assessor-masked, randomised clinical trial Challenge-VRT showed short-term efficacy in reducing the severity of auditory verbal hallucinations in patients with schizophrenia, and the ...