Is Olfaction the Key to PTSD

PTSD Clinical Trial

Official title:

Is Olfaction the Key to PTSD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05640882
• Other study ID #: 060322sm
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2022
• Source: Bar-Ilan University, Israel
• Contact: Sara Freedman, Prof.
• Phone: +972 3 5317736
• Email: sara.freedman[@]biu.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• hebrew native speaker

• understand study requirements

Exclusion Criteria:

• current psychiatric disorder

• suicidality

• vertigo

• epilepsy

Related Conditions & MeSH terms

• PTSD

Intervention

Other:
• VRET
10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure
• VRET OLFACTION
10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure with the addition of olfaction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bar-Ilan University, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PTSD Symptoms Levels Before Treatment	PTSD Symptom levels as measured by the CAPS, before treatment begins	6 months post traumatic event
Primary	PTSD Status	PTSD diagnosis as measured by the CAPS	3 months after end of treatment
Primary	PTSD Levels	PTSD Symptoms Levels as measured by the CAPS continuous score	3 months after end of treatment