NCT06968312

Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD

Testing Potential Enhancement of Standard Cognitive Processing Therapy for PTSD Using Hexadecanal: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tel Aviv University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This RCT investigates whether Cognitive Processing Therapy, a first line treatment for PTSD, can be enhanced by the use of the odor molecule Hexadecenal (HEX). HEX is secreted from body odor and has been shown to promotes psychological well-being and positive social interaction. For the active group Hex will be diffused in the treatment room during all treatment sessions. For the control group a vehicle placebo molecule will be diffused. Both therapists and patients will be blind to study condition.

Detailed description

In this triple blind (patient, therapist, independent evaluator) RCT, 40 patients with PTSD receiving standard Cognitive Processing Therapy will be randomized in a 1:1 ratio to receive either odorless Hexadecanal molecules or odorless mineral oil molecules (Control) diffused in the treatment room at all therapy sessions. Inclusion criteria: age\>18 years, PTSD diagnosis according to DSM-5-TR. Exclusion: Bipolar, psychotic, or neurological disorders, drug abuse, any parallel psychotherapy, anosmia. Primary outcome: pre-to-post treatment change in PTSD symptom severity measured by the PTSD check List for DSM-5 (PCL-5). Additional outcomes: Depression (PHQ-9), anxiety (GAD-7), Anger (DAR-5), therapeutic alliance (WAI-SF).

Conditions

• Post Traumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
OTHER	Cognitive Processing Therapy + Hexadecanal	Cognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD.
OTHER	Hexadecanal - Molecule Distribution in the Therapy room	Distribution of a naturally secreted molecule from body odor (Hexadecanal).

Timeline

• Start date: 2025-05-05
• Primary completion: 2026-09-30
• Completion: 2026-12-30
• First posted: 2025-05-13
• Last updated: 2025-05-16

Locations

1 site across 1 country: Israel