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

NCT07112261 | Active Not Recruiting DMC

• 1 other identifier: 2024-3661
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Treatment-Resistant Major Depressive Disorder

Keywords

treatment-resistant major depressive disorder; relational therapy; virtual reality therapy

Outcome Measures

Primary Outcomes (2)

• Change in depressive symptoms (Modified Hamilton Depression Rating Scale)

  Depressive symptom severity was assessed using a clinician-rated scale composed of 25 items, derived from an unstructured clinical interview. Range 0-72, higher values indicating a more severe depressive symptoms.

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

• Change in depressive symptoms (Patient Health Questionnaire-9)

  Depressive symptom severity was also assessed using a 9-item self-report instrument. Range 0-27, higher values indicating a more severe depressive symptoms.

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

Secondary Outcomes (4)

• Change in anxiety symptoms (Generalized Anxiety Disorder-7)

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

• Change in self-esteem (Rosenberg Self-Esteem Scale)

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

• Change in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire)

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

• Deficit in functioning and disability (World Health Organization Disability Assessment Schedule 2.0)

  Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months

Study Arms (1)

Avatar Therapy

EXPERIMENTAL

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.

Other: Avatar Therapy

Interventions

Avatar Therapy 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.

Avatar Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

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

Montreal, Quebec, H1N 3M5, Canada

Location

Study Officials

• Alexandre Dumais, Md, PhD

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

  PRINCIPAL INVESTIGATOR

• Stéphane Potvin, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)