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Is Olfaction the Key to PTSD

Is Olfaction the Key to PTSD

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05640882
Enrollment
1000
Registered
2022-12-07
Start date
2023-01-01
Completion date
2026-01-01
Last updated
2022-12-07

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

Conditions

PTSD

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.

Detailed description

The goal of this project is to carry out a systematic longitudinal study with an embedded RCT examining olfactory memories in PTSD, in order to test the following hypotheses. Firstly, olfactory memories occur after all traumatic events; secondly, olfactory memories are predictors of PTSD development and thirdly, adding olfaction to PTSD treatment will enhance treatment outcome. The project comprises of a longitudinal study recruiting participants in the Emergency Room within hours of a traumatic event, assessing them at two weeks post trauma for olfactory memories, and at six months for PTSD. This will allow the first two hypotheses to be examined. Participants with PTSD and olfactory memories will be offered treatment and will be randomized to a Virtual Reality Exposure Therapy with and without added odors. Post treatment assessments will examine the third hypothesis.

Interventions

OTHERVRET

10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure

OTHERVRET OLFACTION

10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure with the addition of olfaction

Sponsors

Bar-Ilan University, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* hebrew native speaker * understand study requirements

Exclusion criteria

* current psychiatric disorder * suicidality * vertigo * epilepsy

Design outcomes

Primary

MeasureTime frameDescription
PTSD Status3 months after end of treatmentPTSD diagnosis as measured by the CAPS
PTSD Levels3 months after end of treatmentPTSD Symptoms Levels as measured by the CAPS continuous score

Other

MeasureTime frameDescription
PTSD Symptoms Levels Before Treatment6 months post traumatic eventPTSD Symptom levels as measured by the CAPS, before treatment begins

Contacts

Primary ContactSara Freedman, Prof.
sara.freedman@biu.ac.il+972 3 5317736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026