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A pilot study of virtual reality exposure therapy that alternates calming and mildly stressful scenarios for adults with anxiety

Feasibility and preliminary efficacy of virtual reality emotional contrast exposure therapy for adults with Generalized Anxiety Disorder: a single-arm pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92638354
Enrollment
15
Registered
2026-01-13
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder (GAD) with moderate-to-severe anxiety symptoms. Mental and Behavioural Disorders

Interventions

Participants will receive a single-arm virtual reality emotional-contrast exposure intervention delivered in person over three visits (~45–60 minutes each), scheduled approximately one week apart. Eac
each scenario will last 2 minutes and relaxation segments will last ~3–5 minutes. The order of the anxiety-inducing scenarios will be counterbalanced across participants using a Latin square. No contr

Sponsors

York University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactBarbora Darmová
info@vresearch.org+420732121003

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026