Generalized Anxiety Disorder (GAD) with moderate-to-severe anxiety symptoms. Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older. 2. Prior clinical diagnosis of generalized anxiety disorder (self-reported). 3. Meets the study’s screening threshold for at least moderate anxiety (GAD-7 = 10). 4. Able to provide informed consent in English. 5. Able and willing to complete all study procedures, including three in-person VR visits and the 1-month follow-up assessment.
Exclusion criteria
Exclusion criteria: 1. History of epilepsy or other photosensitive seizure disorder. 2. Severe motion sickness or vestibular disorder likely to be triggered by virtual reality. 3. Severe uncontrolled medical condition that could increase risk during induced anxiety (e.g., serious heart problems). 4. Severe psychiatric comorbidity that could increase risk during induced anxiety (e.g., active psychosis). 5. Pregnancy (excluded as a precaution).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Generalized anxiety symptom severity measured using the Generalized Anxiety Disorder-7 (GAD-7) total score at baseline (online pre-session), immediately post-intervention (after Session 3), and 1-month follow-up (online);Within-session subjective distress measured using the Subjective Units of Distress Scale (SUDS) rated 1-9 at after each anxiety-inducing VR scenario and after final relaxation segment within each of the three sessions;Within-session emotional state measured using the Self-Assessment Manikin (SAM) valence, arousal, and dominance subscales (each rated 1-9) at after each anxiety-inducing VR scenario and after final relaxation segment within each of the three sessions | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate reactivity measured using heart rate (HR) in beats per minute recorded via Polar H10 chest strap at continuous recording during all VR segments (anxiety-inducing and relaxation) across three sessions;Heart rate variability measured using the Root Mean Square of Successive Differences (RMSSD) derived from beat-to-beat intervals via Polar H10 chest strap at continuous recording during all VR segments (anxiety-inducing and relaxation) across three sessions;Somatic and cognitive anxiety symptoms measured using the Beck Anxiety Inventory (BAI) total score at baseline (online pre-session), immediately post-intervention (after Session 3), and 1-month follow-up (online);State and trait anxiety measured using the State-Trait Anxiety Inventory (STAI) state and trait subscale total scores at baseline (online pre-session), immediately post-intervention (after Session 3), and 1-month follow-up (online);Depressive symptoms measured using the Beck Depression Inventory-II (BDI-II) total score at baseline (online pre-session), immediately post-intervention (after Session 3), and 1-month follow-up (online);VR-induced cybersickness measured using the Simulator Sickness Questionnaire (SSQ) total score at immediately after each of the three VR sessions;Sense of presence in VR measured using te Igroup Presence Questionnaire (IPQ) total score at immediately after each of the three VR sessions | — |
Countries
Canada