Treatment-Resistant Major Depressive DisorderNCT07112261
Avatar Therapy in Virtual Reality for Treatment-Resistant Major Depressive Disorder: A Pilot Study
A study testing Avatar Therapy in people with Treatment-Resistant Major Depressive Disorder, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
This pilot clinical trial aimed to evaluate the short-term efficacy of Avatar therapy for treatment-resistant major depressive disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment-Resistant Major Depressive Disorder
- What is being tested?
- Avatar Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current SUD for a substance
- Presence of neurological disorders ;
- Presence of a severe and unstable physical illness ;
- Inability to provide consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche de l'institut universitaire en santé mentale de Montréal
Montreal, Quebec, H1N 3M5
About this study
Official title: Thérapie Avatar Pour le Traitement du Trouble dépressif caractérisé réfractaire : Une étude Pilote
This pilot clinical trial aimed to evaluate the short-term efficacy of Avatar therapy for treatment-resistant major depressive disorder
Read the 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.
- Being tested
- Avatar Therapy
- Keywords
- treatment-resistant major depressive disorder, relational therapy, virtual reality therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatar TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Avatar Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Anxiety symptom severity was assessed using a 7-item self-report questionnaire. Range 0-21, higher values indicating a more severe anxiety symptoms.
Measured: 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)
Self-esteem was measured using a 10-item scale. Range 10-40, higher values indicate a better self-esteem,
Measured: 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)
16-item self-reported scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning; Range 14-70, Higher values indicate a better satisfaction of life QLS: 21-item scale based on a semistructured interview designed to assess deficit symptoms; Range 0-126, higher values indicate a better quality of life
Measured: 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)
Functioning and disability were assessed using a self-report instrument comprising 36 items, covering six domains: cognition, mobility, self-care, getting along with others, life activities, and participation in society. Total scores range from 36 to 180, with lower scores indicating better functioning.
Measured: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-Resistant Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Dumais, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Alexandre Dumais, Md, PhD, Principal investigator, University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de MontréalStéphane Potvin, PhD, Principal investigator, University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112261
- Sponsor's protocol ID
- 2024-3661
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thérapie Avatar Pour le Traitement du Trouble dépressif caractérisé réfractaire : Une étude Pilote
- ClinicalTrials.gov ID
- NCT07112261
- Acronym / sponsor ID
- 2024-3661
- Keywords
- treatment-resistant major depressive disorder, relational therapy, virtual reality therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avatar Therapy | Experimental | Other: Avatar TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Current SUD for a substance
- Presence of neurological disorders ;
- Presence of a severe and unstable physical illness ;
- Inability to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatar TherapyThe 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 |
Primary outcome
Change in depressive symptoms (Modified Hamilton Depression Rating Scale)
Time frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
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.
Change in depressive symptoms (Patient Health Questionnaire-9)
Time frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Depressive symptom severity was also assessed using a 9-item self-report instrument. Range 0-27, higher values indicating a more severe depressive symptoms.
4 secondary outcomes
Change in anxiety symptoms (Generalized Anxiety Disorder-7)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Dumais, Md, PhD principal investigator
University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de Montréal
Stéphane Potvin, PhD principal investigator
University of Montreal, Centre de recherche de l'institut universitaire en santé mentale de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avatar Therapy in people with Treatment-Resistant Major Depressive Disorder, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms (Modified Hamilton Depression Rating Scale) (time frame: Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.