CClinicalTrials.gg
Not yet recruitingNCT05640882Updated Dec 7, 2022

Is Olfaction the Key to PTSD

An interventional study of VRET and VRET OLFACTION in PTSD, sponsored by Bar-Ilan University, Israel. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by Bar-Ilan University, Israel · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • PTSD
03

In context

Lead sponsor

Bar-Ilan University, Israel is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • hebrew native speaker
  • understand study requirements

Exclusion criteria

Exclusion Criteria:

  • current psychiatric disorder
  • suicidality
  • vertigo
  • epilepsy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    VRET

    VRET - 10 week protocol using VR

    Other: VRET

  • Active comparator
    VRET Olfaction

    VRET olfaction - 10 week protocol using VR with olfaction

    Other: VRET OLFACTION

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

06

What researchers measure

Primary outcomes

  1. PTSD Status

    PTSD diagnosis as measured by the CAPS

    Time frame: 3 months after end of treatment

  2. PTSD Levels

    PTSD Symptoms Levels as measured by the CAPS continuous score

    Time frame: 3 months after end of treatment

Other outcomes

  1. PTSD Symptoms Levels Before Treatment

    PTSD Symptom levels as measured by the CAPS, before treatment begins

    Time frame: 6 months post traumatic event

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05640882
Lead sponsor
Bar-Ilan University, Israel
Responsible party
Sara Freedman (prof., Bar-Ilan University, Israel) — Principal investigator
First posted
Dec 7, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Jan 1, 2025 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Dec 7, 2022

Study contacts

Sara Freedman, Prof.
Contact
sara.freedman@biu.ac.il
+972 3 5317736

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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