Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD

Not Applicable

Recruiting

• Conditions: Post Traumatic Stress Disorder (PTSD)

• Registration Number: NCT06968312
• Lead Sponsor: Tel Aviv University

Brief 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).

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of PTSD according to DSM-5
• Age 18 years and over
• Eligible for CPT treatment at the National Center for Traumatic Stress and Resilience

Exclusion Criteria

• Bipolar disorder, psychosis, neurological disorders
• Drug Addiction
• Parallel psychotherapy
• Congenital or acquired anosmia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PTSD Checklist (PCL-5)	12-16 weeks	A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire - 9 (PHQ-9)	12-16 weeks	A 9-item self-reported questionnaire on depression symptoms according to DSM-5
Generalized Anxiety Disorder -7 (GAD-7)	12-16 weeks	A 7-item self-reported questionnaire on generalized anxiety
Dimensions of Anger Reactions - 5 (DAR-5)	12-16 weeks	A 5-item self-reported questionnaire on anger
Working Alliance Inventory Short Form (WAI-SF	12-16 weeks	Completed by patent and therapist - ranks the quality of therapeutic alliance

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Tel Aviv, Israel