NCT03585127

Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia

Completed NA Last updated 17 July 2020

What this trial tests

NA trial testing Cognitive Behavioral Therapy in Auditory Hallucination, Verbal in 74 participants. Completed in 1 July 2020.

Timeline

1 March 2017

Primary endpoint
31 March 2020

1 July 2020

Quick facts

Lead sponsor	Ciusss de L'Est de l'Île de Montréal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	1 March 2017
Primary completion	31 March 2020
Estimated completion	1 July 2020
Sites	1 location across Canada

Drugs / interventions tested

• Cognitive Behavioral Therapy
• Avatar Therapy

Conditions studied

• Auditory Hallucination, Verbal — all drugs for Auditory Hallucination, Verbal →
• Treatment-resistant Schizophrenia — all drugs for Treatment-resistant Schizophrenia →

Sponsor

Ciusss de L'Est de l'Île de Montréal — full company profile →

Who can join

18 and older, any sex, with Auditory Hallucination, Verbal or Treatment-resistant Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society. Unfortunately, 25-30% of schizophrenia patients respond poorly to antipsychotic medication. Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population. This unmet clinical need requires innovation and action. Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) provide at best moderate results. Using immersive virtual reality, we recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of the patient's distressing voice. This approach, being both relational and experiential, provides a unique opportunity to aid patients gain control over their voice. The results of our pilot study on AT were clinically promising for the severity and distress related to hallucinations, positive symptomatology and emotion regulation. To further research in this field, the primary goal of this randomized-controlled, single-site parallel study is to show that AT is superior to CBT for the treatment of persistent auditory hallucinations in schizophrenia. Our secondary goal is to examine the effects of these interventions on emotion regulation, mood symptoms (anxiety and depression), self-esteem, level of functioning and quality of life.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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, Dumais A. · · 2021 · cited 56× · PMID 33580033 · DOI 10.1038/s41537-021-00139-2
2. Avatar Therapy for people with schizophrenia or related disorders.
   Aali G, Kariotis T, Shokraneh F. · · 2020 · cited 20× · PMID 32413166 · DOI 10.1002/14651858.cd011898.pub2
3. 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, Dumais A. · · 2020 · cited 16× · PMID 33007909 · DOI 10.3390/jcm9103169
4. 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, Dellazizzo L, et al · · 2023 · cited 4× · PMID 37308864 · DOI 10.1186/s12888-023-04861-2
5. Unsupervised Machine Learning Driven Analysis of Verbatims of Treatment-Resistant Schizophrenia Patients Having Followed Avatar Therapy.
   Hudon A, Beaudoin M, Phraxayavong K, Potvin S, et al · · 2023 · cited 3× · PMID 37240971 · DOI 10.3390/jpm13050801
6. Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study.
   Giguère S, Potvin S, Beaudoin M, Dellazizzo L, et al · · 2023 · cited 3× · PMID 37240936 · DOI 10.3390/jpm13050766
7. The impacts of the COVID-19 pandemic on treatment-resistant schizophrenia patients having followed virtual reality therapy or cognitive behavioural therapy: a content analysis.
   Hudon A, Léveillé N, Sanchez-Schicharew K, Dellazizzo L, et al · · 2022 · cited 3× · PMID 36102593 · DOI 10.1080/07853890.2022.2121852
8. Enhancing Predictive Power: Integrating a Linear Support Vector Classifier with Logistic Regression for Patient Outcome Prognosis in Virtual Reality Therapy for Treatment-Resistant Schizophrenia.
   Hudon A, Beaudoin M, Phraxayavong K, Potvin S, et al · · 2023 · cited 2× · PMID 38138887 · DOI 10.3390/jpm13121660