PTSDNCT05640882
Is Olfaction the Key to PTSD
A study testing VRET and VRET OLFACTION in people with PTSD, run by Bar-Ilan University, Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- VRET and VRET OLFACTION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- hebrew native speaker
- understand study requirements
Who cannot join
- current psychiatric disorder
- suicidality
- vertigo
- epilepsy
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- PTSD
- Being tested
- VRET, VRET OLFACTION
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRETOther
10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure
VRET OLFACTIONOther
10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure with the addition of olfaction
| Study group | Role | What they receive |
|---|---|---|
| VRET | Experimental | VRET - 10 week protocol using VR Receives: Other: VRET |
| VRET Olfaction | Active comparator | VRET olfaction - 10 week protocol using VR with olfaction Receives: Other: VRET OLFACTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Status
PTSD diagnosis as measured by the CAPS
Measured: 3 months after end of treatment
PTSD Levels
PTSD Symptoms Levels as measured by the CAPS continuous score
Measured: 3 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Freedman, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640882
- Sponsor's protocol ID
- 060322sm
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Olfaction the Key to PTSD
- ClinicalTrials.gov ID
- NCT05640882
- Acronym / sponsor ID
- 060322sm
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRET | Experimental | Other: VRETVRET - 10 week protocol using VR |
| VRET Olfaction | Active comparator | Other: VRET OLFACTIONVRET olfaction - 10 week protocol using VR with olfaction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hebrew native speaker
- understand study requirements
Key exclusion criteria (4 listed)
- current psychiatric disorder
- suicidality
- vertigo
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRET10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure | Other | VRET |
| VRET OLFACTION10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure with the addition of olfaction | Other | VRET Olfaction |
Primary outcome
PTSD Status
Time frame: 3 months after end of treatment
PTSD diagnosis as measured by the CAPS
PTSD Levels
Time frame: 3 months after end of treatment
PTSD Symptoms Levels as measured by the CAPS continuous score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing VRET and VRET OLFACTION in people with PTSD, run by Bar-Ilan University, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Freedman, Prof. (+972 3 5317736, sara.freedman@biu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Status (time frame: 3 months after end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.