Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT07112261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avatar Therapy in Virtual Reality for Treatment-Resistant Major Depressive Disorder: A Pilot Study
Sponsor:
Ciusss de L'Est de l'Île de Montréal
Organization:
Study Overview
Official Title:
Thérapie Avatar Pour le Traitement du Trouble dépressif caractérisé réfractaire : Une étude Pilote
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: