Is Olfaction the Key to PTSD

Sponsor
Bar-Ilan University, Israel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05640882
Collaborator
(none)
1,000
2
36

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: VRET
  • Other: VRET OLFACTION
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Is Olfaction the Key to PTSD
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: VRET

VRET - 10 week protocol using VR

Other: VRET
10 week prolonged exposure protocol, using Virtual Reality for imaginal exposure

Active Comparator: VRET Olfaction

VRET olfaction - 10 week protocol using VR with olfaction

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

Outcome Measures

Primary Outcome Measures

  1. PTSD Status [3 months after end of treatment]

    PTSD diagnosis as measured by the CAPS

  2. PTSD Levels [3 months after end of treatment]

    PTSD Symptoms Levels as measured by the CAPS continuous score

Other Outcome Measures

  1. PTSD Symptoms Levels Before Treatment [6 months post traumatic event]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • hebrew native speaker

  • understand study requirements

Exclusion Criteria:
  • current psychiatric disorder

  • suicidality

  • vertigo

  • epilepsy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bar-Ilan University, Israel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Freedman, prof., Bar-Ilan University, Israel
ClinicalTrials.gov Identifier:
NCT05640882
Other Study ID Numbers:
  • 060322sm
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 7, 2022