Is Olfaction the Key to PTSD

Not Applicable

Not yet recruiting

• Conditions: PTSD
• Interventions: Other: VRET OLFACTION; Other: VRET

• Registration Number: NCT05640882
• Lead Sponsor: Bar-Ilan University, Israel

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07
• Study Start: 2023-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• hebrew native speaker
• understand study requirements

Exclusion Criteria

• current psychiatric disorder
• suicidality
• vertigo
• epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VRET Olfaction	VRET OLFACTION	VRET olfaction - 10 week protocol using VR with olfaction
VRET	VRET	VRET - 10 week protocol using VR

Primary Outcome Measures

Name	Time	Method
PTSD Status	3 months after end of treatment	PTSD diagnosis as measured by the CAPS
PTSD Levels	3 months after end of treatment	PTSD Symptoms Levels as measured by the CAPS continuous score