Emotion regulation/dysregulation Mental and Behavioural Disorders
Conditions
Interventions
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 t
Sponsors
Douglas Mental Health University Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 2. Psychiatric Symptoms (anxiety, depression, PTSD, substance use disorders) will be monitored for change in symptom severity and any loss/gain of probable psychiatric diagnosis (for screening measures). The measures are Generalized Anxiety Disorder Scale-7 item, Patient Health Questionnaire - 9 item, Primary Care Screen for PTSD DSM-5 item (PC-PTSD-5), Alcohol Use Disorders Identification Test- version C, and Drug Abuse Screening Test-10 item, given on at both baselines (pre-post) and every 2-4 weeks during the intervention. 3. We will monitor any change in psychological distress and well-being, Clinical outcome in routine evaluation outcome measure and 10 item (CORE- OM/10) and Short/ Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS/WEMWBS) at baselines (pre-post) and every 2-4 weeks during the intervention. 4. Feasibility of interventions is assessed by the number (percentages) of sessions attended (or completed at home), treatment completion/drop-out, use of the at-home VR program over 10 weeks of the intervention period (researcher recorded)] | — |
Countries
Canada
Contacts
Public ContactQuinta Seon
Outcome results
None listed