Is Olfaction the Key to PTSD
1 other identifier
interventional
1,000
0 countries
N/A
Brief Summary
Participants arriving to the ED following a potentially traumatic event such as a motor vehicle accident will be recruited into the study. Inclusion criteria: aged 18-65, Hebrew as a first language, no current psychiatric disorder. Exclusion criteria: loss of consciousness, unable to understand study procedure. Participants will answer self report questionnaires in the ED. They will be invited for a follow up interview 2 weeks and six months post trauma. Between 2 weeks and 6 months they will be folllowed up via online questionnaires. At the interviews, they will encounter 20 different olfactory stimuli, answer self-report questionnaires, and a clinical interview assessing Axis 1 disorders and PTSD will be completed. At six month, participants with PTSD will be offered therapy in the embedded RCT. Patients will receive VRET (Virtual reality exposure therapy) with or without olfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2022
CompletedFirst Posted
Study publicly available on registry
December 7, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedDecember 7, 2022
November 1, 2022
2 years
November 17, 2022
November 28, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
PTSD Status
PTSD diagnosis as measured by the CAPS
3 months after end of treatment
PTSD Levels
PTSD Symptoms Levels as measured by the CAPS continuous score
3 months after end of treatment
Other Outcomes (1)
PTSD Symptoms Levels Before Treatment
6 months post traumatic event
Study Arms (2)
VRET
EXPERIMENTALVRET - 10 week protocol using VR
VRET Olfaction
ACTIVE COMPARATORVRET olfaction - 10 week protocol using VR with olfaction
Interventions
10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure with the addition of olfaction
Eligibility Criteria
You may qualify if:
- hebrew native speaker
- understand study requirements
You may not qualify if:
- current psychiatric disorder
- suicidality
- vertigo
- epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof.
Study Record Dates
First Submitted
November 17, 2022
First Posted
December 7, 2022
Study Start
January 1, 2023
Primary Completion
January 1, 2025
Study Completion
January 1, 2026
Last Updated
December 7, 2022
Record last verified: 2022-11