Avatar Therapy in Virtual Reality for Treatment-Resistant Major Depressive Disorder: A Pilot Study

NCT ID: NCT07112261

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-09-01

Brief Summary

This pilot clinical trial aimed to evaluate the short-term efficacy of Avatar therapy for treatment-resistant major depressive disorder

Detailed Description

Major depressive disorder (MDD) is among the most common and disabling mental health conditions worldwide. However, treatment-resistant major depressive disorder (TR-MDD) is a prevalent clinical challenge and public health concern. While various pharmacological and psychotherapeutic treatments are available, a significant proportion of individuals do not achieve adequate symptom relief. Indeed, approximately 30% to 55% of individuals with MDD remain symptomatic after two adequate antidepressant trials, and psychotherapy has shown only modest efficacy in treatment-resistant cases. In this context, our research team developed Avatar therapy, an approach using virtual reality as a therapeutic tool to treat TR-MDD. The Avatar Therapy for TR-MDD displays strong experiential and relational components that are crucially missing in conventional interventions.

Throughout the 10 therapy sessions, participants were allowed to engage in a dialogue in virtual reality with an avatar representing a person who played a significant role in their depressive symptoms, which was animated in real-time by a therapist. The primary outcomes was severity of depressive symptoms. Secondary outcomes included severity of anxiety symptoms, self-esteem, quality of life and functioning. The investigators will also explore whether the greater improvements attributable to the Avatar Therapy persist in time.

Given the high prevalence of individuals with TR-MDD and the negative repercussions for individuals, their entourage, and society, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.

Conditions

Treatment-Resistant Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avatar Therapy

The Avatar Intervention will take place over 10 consecutive weeks, with one session per week. 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. The goal of the therapy is to develop strategies to improve mood and promote the fulfillment of social functioning.

Group Type: EXPERIMENTAL

Avatar Therapy

Intervention Type: OTHER

The Avatar Intervention will take place over 10 consecutive weeks, with one session per week. 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. The goal of the therapy is to develop strategies to improve mood and promote the fulfillment of social functioning.

Interventions

Avatar Therapy

The Avatar Intervention will take place over 10 consecutive weeks, with one session per week. 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. The goal of the therapy is to develop strategies to improve mood and promote the fulfillment of social functioning.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males or females over 18 years of age who meet the DSM-5 criteria for diagnosis of major depression with persistent depressive symptoms following inadequate response to two or more pharmacological treatment trials.

Exclusion Criteria

• Current SUD for a substance
• Presence of neurological disorders ;
• Presence of a severe and unstable physical illness ;
• Inability to provide consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Dumais

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Dumais, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de Montréal

Stéphane Potvin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de Montréal

Locations

Centre de recherche de l'institut universitaire en santé mentale de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2024-3661

Identifier Type: -

Identifier Source: org_study_id