Can we use virtual reality-assisted cognitive behavioral therapy with Inuit in Quebec?
| ISRCTN | ISRCTN21831510 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21831510 |
| ClinicalTrials.gov (NCT) | NCT05631743 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | IUSMD 21-52 |
| Sponsor | Douglas Mental Health University Institute |
| Funders | MEDTEQ, McGill University |
- Submission date
- 26/04/2022
- Registration date
- 29/04/2022
- Last edited
- 08/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Virtual reality (VR) is an interactive, computer-generated three-dimensional world of images, videos and sounds accessed through a VR headset/system. VR-assisted interventions effectively increase mental well-being, such as building the ability to regulate emotions. In a VR environment, an individual can learn skills for healthy control of emotions either as self-management with a recorded guided relaxation or with a psychotherapist being present. In the current study, we will compare home-environment self-management to at-clinic therapist-guided psychotherapy.
Who can participate?
The treatment is provided for Inuit living in the Greater Montreal Area, between the ages of 14 and 60. If successful, this project will improve access to culturally safe and validated psychotherapy for Inuit living in Quebec, independent of their geographical location.
What does the study involve?
The study involves doing one of two mental health programs for 10 weeks and doing some tests and questionnaires. Both programs involve mental health resources given, in part, with virtual reality (VR).
What are the possible benefits and risks of participating?
When filling out the questionnaires and during and after the psychotherapy session, possible disadvantages include fatigue, discomfort, anxiety, stress or frustration. The questionnaires include questions that can cause mild psychological stress or anxiety. Wearing the VR headset can cause nausea and dizziness. It is temporary and its use will be interrupted immediately. The time the study takes, including travel may be inconvenient.
The research team believes that participating in this research project carries little risk to you. Some people may experience increases in anxiety, unhealthy coping or suicidal ideation through the course of the research project. Wearing the VR headset can sometimes cause epileptic seizures. This risk is minimized using the exclusion criteria for those factors that could predict severe risk.
You may be getting a personal benefit from your participation in this research project, but we cannot assure you of that. Furthermore, we hope the results obtained will contribute to the advancement of scientific knowledge in this area of research, as well as validate new treatments that are culturally safe.
Where is the study run from?
Douglas Mental Health University Institute, Verdun, Quebec (Canada)
When is the study starting and how long is it expected to run for?
January 2019 to December 2024
Who is funding the study?
The study is funded by MEDTEQ FSISSS and Health Brains Healthy Lives (HBHL) grants (Canada)
Who is the main contact?
Outi Linnaranta, outi.linnarata at thl.fi
Contact information
Principal investigator
Mannerheimintie 166
Helsinki
00300
Finland
 ORCID ID |
0000-0002-0383-7215 |
|---|---|
| Phone | +358-29-5247517 |
| outi.linnaranta@thl.fi |
Public
6875 Boulevard Lasalle
Montreal
h4h1r3
Canada
| ORCID ID |
0000-0001-9542-1884 |
|---|---|
| Phone | +1 514-761-6131 ext 3009 |
| quinta.seon@mail.mcgill.ca |
Scientific
CP 1250 Succ Hull
Gatineau
J8X 3X7
Canada
| ORCID ID |
0000-0002-5995-340X |
|---|---|
| Phone | +1 819-595-3900-2360 |
| Stephane.bouchard@uqo.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre proof-of-concept interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A virtual reality-assisted cognitive behavioral therapy (VR-CBT) for and with Inuit in Quebec - a proof-of-concept randomized controlled trial |
| Study objectives | We 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). |
| Ethics approval(s) | Approved 22/10/2021, CIUSSS de l'Ouest-de-l'Ile-de-Montreal Research Ethics Board (Biomedical subcommittee, 6875, boulevard LaSalle, FBC 1116, Montréal, Québec, H4H 1R3, Canada; +1 514 761-6131 poste 2708; cer.reb@douglas.mcgill.ca), ref: IUSMD 21-52 |
| Health condition(s) or problem(s) studied | Emotion regulation/dysregulation |
| Intervention | The study design is a two-arm randomized controlled pilot trial (simple 1:1 randomization using a random number generator, unblinded). We will recruit Inuit in Quebec 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 building emotion regulation through guided relaxation during ten weeks at home. To evaluate outcome in both groups, we will measure self-reports of emotion regulation, affect, distress and well-being throughout, as well as a psychophysiological reactivity paradigm pre-post treatment. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Emotion regulation is measured using the Difficulties in Emotion Regulation Scale-16 item (a short, valid measure of emotion regulation) at pre-intervention, during (every two weeks) and post-intervention. |
| Key secondary outcome measure(s) |
1. Reactivity to stress via subjective and objective markers is measured during a psychophysiological reactivity testing paradigm. We measure psychophysiology, such as heart rate, heart rate variability, and skin conductance during a baseline 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, emotional arousal, and emotional valence (VAS-A, EA, EV) are given during each segment of this test as well. 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 and increased heart rate variability and decreased skin conductance response. Time Frame: Approximately 1-hour testing session, administered twice. |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 14 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Self-identify as Inuk 2. Live in Montreal 3. Between 14 to 60 years of age 4. Proficient in English or French 5. No history of cardiac conditions 6. No history of epilepsy 7. Can provide an emergency contact 8. Tolerance of VR headset 9. Tolerance of sensors 10. Has no current suicidal or homicidal risk 11. No history of psychosis or schizophrenia 12. Current stable mood 13. Is generally mentally stable (no current suicidality, need for hospitalization, etc) 14. Score less than 8 on the Alcohol Use Disorders Identification Test C 15. Score less than 3 on the Drug Abuse Screen Test (10 item version) 16. Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion in the study |
| Key exclusion criteria | 1. Does not identify as Inuk 2. Youth below the age of 14 and adults above the age of 60. 3. Self-reported history of psychosis or schizophrenia 4. Current substance abuse, as measured by two screens (AUDIT-C, DAST-10) 5. Other mental or physical condition that might preclude them from the trial (i.e. pre-existing heart conditions, convulsions, acute mental health risk). |
| Date of first enrolment | 30/06/2022 |
| Date of final enrolment | 01/09/2024 |
Locations
Countries of recruitment
- Canada
Study participating centre
Verdun
Montreal
H4H 1R3
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality of participants and cultural sensitivity. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 24/05/2023 | 25/05/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/04/2024: ClinicalTrials.gov number added.
12/10/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 01/09/2023 to 01/09/2024.
2. The overall study end date was changed from 31/12/2023 to 31/12/2024.
3. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
25/05/2023: Publication reference added.
28/04/2022: Trial's existence confirmed by Le Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Ouest-de-l'Île-de-Montréal.
