Emotion RegulationNCT05631743
VR-CBT With Inuit in Quebec
A study testing VR-CBT and Self-management in people with Emotion Regulation, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
The study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- VR-CBT and Self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Self-identify as Inuk
- Live in Montreal
- be between 14 to 60 years of age
- be proficient in English or French
- No history of cardiac conditions
- No history of epilepsy
Show all 16Show fewer
- Can provide an emergency contact
- Tolerance of VR headset
- Tolerance of sensors
- Has no current suicidal or homicidal risk
- No history of psychosis or schizophrenia
- Current stable mood
- Is generally mentally stable
- Score less than 8 on the Alcohol Use Disorders Identification Test C
- Score less than 3 on the Drug Abuse Screen Test (10 item version)
- Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion to the study
Who cannot join
- does not identify as Inuk
- youth below the age of 14 and adults above the age of 60.
- self-reported history of psychosis or schizophrenia
- current substance abuse, as measured by two screens (AUDIT-C, DAST-10)
- other mental or physical condition that might preclude them from the trial (i.e., pre-existing heart conditions, convulsions, acute mental health risk).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, h4h 1r3
About this study
Official title: A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial
The study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will measure self-reports of emotion regulation, affect, distress and well-being, as well as a psychophysiological reactivity paradigm pre-post treatment.
Read the detailed description
In this protocol, the investigators present a proof-of-concept trial that will evaluate an active psychotherapy and self-management, both targeting emotion regulation skills. The study design is a two-arm randomized controlled trial. The investigators will recruit Inuit and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation, a set of skills or competence that is impacted by traumatic experiences and mediates the effect of trauma on psychiatric symptoms. The investigators conducted a cultural adaptation of the therapy for Inuit with a co-design grounded in qualitative participatory methods. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will include a psychophysiological reactivity paradigm pre-post treatment and self-reports of emotion regulation, anxiety, mood, substance use, functionality and quality of life. The investigators expect to see preliminary evidence that our VR-CBT can be more successful than guided VR relaxation with Calm Place (self-management) decreasing difficulties in emotion regulation, psychiatry symptoms, increasing well-being, and normalizing responses to stressful stimuli (reactivity).
- Conditions
- Emotion Regulation
- Being tested
- VR-CBT, Self-management
- Keywords
- virtual reality, cognitive behavioural therapy
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-CBTBehavioural
The therapy is focused on emotion regulation through guided learning in virtual reality. The manual is a modified conventional cognitive behavioral therapy to include these aspects and the suggestions of an advisory committee of Inuit and non-Inuit health service providers (e.g., cultural adaptation).
Self-managementBehavioural
The previously developed commercial VR program involves guided relaxation and meditation techniques.
| Study group | Role | What they receive |
|---|---|---|
| VR-CBT | Experimental | A trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks. Receives: Behavioral: VR-CBT |
| Self-management | Active comparator | Participants use a commercial VR application at home for guided self-management at their own pace over 10 weeks. Receives: Behavioral: Self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Regulation
Difficulties in Emotion Regulation Scale-16 is a short, valid measure of emotion regulation, scored from 16(low difficulties)-80 (higher difficulties).
Measured: Approximately 5 minutes
Secondary outcomes (15)
heart rate
The participants undergo a psychophysiological reactivity testing paradigm, where we measure heart rate (in beats per minute) during a baseline, forest walk and height exposure in VR. The paradigm testing will be done during the initial visit and the last visit after the end of the VR intervention (minimum of seven and maximum of ten weeks). We measure changes in reactivity and resting level responses as compared from relaxed (forest walk) to height exposure, expecting lower resting levels of heart rate.
Measured: Approximately 1 hour testing session.
heart rate variability
The participants undergo a psychophysiological reactivity testing paradigm, where we measure heart rate variability baseline, forest walk and height exposure in VR. The paradigm testing will be done during the initial visit and the last visit after the end of the VR intervention (minimum of seven and maximum of ten weeks). We measure changes in reactivity as compared from relaxed (forest walk) to height exposure, increased heart rate variability.
Measured: Approximately 1 hour testing session.
skin conductance response
The participants undergo a psychophysiological reactivity testing paradigm, where we measure skin conductance during a baseline, forest walk and height exposure in VR. The paradigm testing will be done during the initial visit and the last visit after the end of the VR intervention (minimum of seven and maximum of ten weeks). We measure changes in reactivity and resting level responses as compared from relaxed (forest walk) to height exposure, expecting decreased skin conductance response.
Measured: Approximately 1 hour testing session.
anxiety (momentary)
The participants undergo a psychophysiological reactivity testing paradigm, involving during a baseline, forest walk and height exposure in VR. The paradigm testing will be done during the initial visit and the last visit after the end of the VR intervention (minimum of seven and maximum of ten weeks). Visual analogue scales for anxiety are given during each segment of this test, scored 0 to 100 (not at all anxious- very anxious).
Measured: Approximately 1 hour testing session.
emotional arousal (momentary)
The participants undergo a psychophysiological reactivity testing paradigm, involving during a baseline, forest walk and height exposure in VR. The paradigm testing will be done during the initial visit and the last visit after the end of the VR intervention (minimum of seven and maximum of ten weeks). Visual analogue scales for emotional arousal are given during each segment of this test, scored 0-100 (very calm- very excited).
Measured: Approximately 1 hour testing session.
emotional valence (momentary)
The participants undergo a psychophysiological reactivity testing paradigm, involving during a baseline, forest walk and height exposure in VR. The paradigm testing will be done during the initial visit and the last visit after the end of the VR intervention (minimum of seven and maximum of ten weeks). Visual analogue scales for emotional valence are given during each segment of this test, scored 0-100 (very pleasant-very unpleasant).
Measured: Approximately 1 hour testing session.
Psychiatric Symptoms (anxiety)
We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Generalized Anxiety Disorder Scale-7 is a scale scored 0-21 (minimal anxiety to severe anxiety).
Measured: Administration time is around 3 minutes
Psychiatric Symptoms (depression)
We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Patient Health Questionnaire - 9 is a scale scored 0-27 (minimal to severe).
Measured: Administration time is around 4 minutes
Psychiatric Symptoms (post traumatic stress disorder)
We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Primary Care Screen for Post-Traumatic Stress Disorder for Diagnostic and Statistical Manual-5 (PC-PTSD-5) is a screening, measure where a score of 3 indicates probable post-traumatic stress.
Measured: Administration time is between 2 minutes
Psychiatric Symptoms (alcohol use disorder)
We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Alcohol Use Disorders Identification Test- C screens for probably alcohol use disorder with a score of 3 or 4.
Measured: Administration time is between 2 minutes
Psychiatric Symptoms (substance use disorders)
We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Drug Abuse Screening Test-10 is a scale scored from 0-10, with higher scores indicating more intensive assessment needed.
Measured: Administration time is between 4 minutes
Psychological distress and well being: Clinical outcome in routine evaluation outcome measure and 10 item (CORE- OM/10)
We will monitor any change in psychological well-being, as measured by a scale for psychological distress (constituted by multiple subscales including well being). The scale can operate as a screening tool with a score of 10 or 11.
Measured: Approximately 10 minutes
Psychological distress and well being: Short/ Warwick Edinburgh Mental Wellbeing Scale
We will monitor any change in psychological well-being, as measured by a scale which covers mental wellbeing as a feeling and function, expecting wellbeing to increase and distress to decrease. Higher scores indicate higher wellbeing (short version is scored 7-35; long version 14-70).
Measured: Approximately 10 minutes
Feasibility of interventions (attendance/useage)
The number (percentages) of sessions attended (or completed at home) will serve as indicators of feasibility.
Measured: 10 weeks of intervention period (researcher recorded)
Feasibility of interventions (treatment completion)
Treatment completion (minimum of 7 sessions of VR in either arm) and drop-outs will serve as indicators of feasibility.
Measured: 10 weeks of intervention period (researcher recorded)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start15 Jul 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a proof-of-concept, two-arm RCT with a VR-assisted therapist -guided psychotherapy and self-management.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, MedTeq, Douglas Foundation, McGill University
- Responsible party
- Principal investigator, Martin Lepage, Douglas Mental Health University Institute
- Investigators
- Outi Linnaranta, MD, Ph.D, Principal investigator, Douglas Mental Health University Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631743
- Sponsor's protocol ID
- IUSMD 21-52
- Status last verified
- Feb 2025
- First submitted
- 21 Oct 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05631743
- Acronym / sponsor ID
- IUSMD 21-52
- Conditions
- Emotion Regulation
- Keywords
- virtual reality, cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, MedTeq, Douglas Foundation, McGill University
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 30 Nov 2022 (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.
The study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will measure self-reports of emotion regulation, affect, distress and well-being, as well as a psychophysiological reactivity paradigm pre-post treatment.
Detailed description
In this protocol, the investigators present a proof-of-concept trial that will evaluate an active psychotherapy and self-management, both targeting emotion regulation skills. The study design is a two-arm randomized controlled trial. The investigators will recruit Inuit and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation, a set of skills or competence that is impacted by traumatic experiences and mediates the effect of trauma on psychiatric symptoms. The investigators conducted a cultural adaptation of the therapy for Inuit with a co-design grounded in qualitative participatory methods. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will include a psychophysiological reactivity paradigm pre-post treatment and self-reports of emotion regulation, anxiety, mood, substance use, functionality and quality of life. The investigators expect to see preliminary evidence that our VR-CBT can be more successful than guided VR relaxation with Calm Place (self-management) decreasing difficulties in emotion regulation, psychiatry symptoms, increasing well-being, and normalizing responses to stressful stimuli (reactivity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a proof-of-concept, two-arm RCT with a VR-assisted therapist -guided psychotherapy and self-management.
| Arm | Type | Receives |
|---|---|---|
| VR-CBT | Experimental | Behavioral: VR-CBTA trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks. |
| Self-management | Active comparator | Behavioral: Self-managementParticipants use a commercial VR application at home for guided self-management at their own pace over 10 weeks. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Self-identify as Inuk
- Live in Montreal
- be between 14 to 60 years of age
- be proficient in English or French
- No history of cardiac conditions
Key exclusion criteria (5 listed)
- does not identify as Inuk
- youth below the age of 14 and adults above the age of 60.
- self-reported history of psychosis or schizophrenia
- current substance abuse, as measured by two screens (AUDIT-C, DAST-10)
- other mental or physical condition that might preclude them from the trial (i.e., pre-existing heart conditions, convulsions, acute mental health risk).
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 |
|---|---|---|
| VR-CBTThe therapy is focused on emotion regulation through guided learning in virtual reality. The manual is a modified conventional cognitive behavioral therapy to include these aspects and the suggestions of an advisory committee of Inuit and non-Inuit health service providers (e.g., cultural adaptation). | Behavioural | VR-CBT |
| Self-managementThe previously developed commercial VR program involves guided relaxation and meditation techniques. | Behavioural | Self-management |
Primary outcome
Emotion Regulation
Time frame: Approximately 5 minutes
Difficulties in Emotion Regulation Scale-16 is a short, valid measure of emotion regulation, scored from 16(low difficulties)-80 (higher difficulties).
15 secondary outcomes
heart rate
Time frame: Approximately 1 hour testing session.
heart rate variability
Time frame: Approximately 1 hour testing session.
skin conductance response
Time frame: Approximately 1 hour testing session.
anxiety (momentary)
Time frame: Approximately 1 hour testing session.
emotional arousal (momentary)
Time frame: Approximately 1 hour testing session.
emotional valence (momentary)
Time frame: Approximately 1 hour testing session.
Psychiatric Symptoms (anxiety)
Time frame: Administration time is around 3 minutes
Psychiatric Symptoms (depression)
Time frame: Administration time is around 4 minutes
Psychiatric Symptoms (post traumatic stress disorder)
Time frame: Administration time is between 2 minutes
Psychiatric Symptoms (alcohol use disorder)
Time frame: Administration time is between 2 minutes
Psychiatric Symptoms (substance use disorders)
Time frame: Administration time is between 4 minutes
Psychological distress and well being: Clinical outcome in routine evaluation outcome measure and 10 item (CORE- OM/10)
Time frame: Approximately 10 minutes
Psychological distress and well being: Short/ Warwick Edinburgh Mental Wellbeing Scale
Time frame: Approximately 10 minutes
Feasibility of interventions (attendance/useage)
Time frame: 10 weeks of intervention period (researcher recorded)
Feasibility of interventions (treatment completion)
Time frame: 10 weeks of intervention period (researcher recorded)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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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.
Outi Linnaranta, MD, Ph.D principal investigator
Douglas Mental Health University Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-CBT and Self-management in people with Emotion Regulation, run by Douglas Mental Health University Institute 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 16 inclusion and 5 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: finished, as of the sponsor's last update on 27 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emotion Regulation (time frame: Approximately 5 minutes). 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 27 Aug 2026.