Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD

NCT06968312 | Recruiting

• 1 other identifier: HEX-PTSD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

Keywords

PTSD; Posttraumatic Stress Disorder; Hexadecanal; treatment; CPT; Cognitive Processing Therapy

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist (PCL-5)

  A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5

  12-16 weeks

Secondary Outcomes (4)

• Patient Health Questionnaire - 9 (PHQ-9)

  12-16 weeks

• Generalized Anxiety Disorder -7 (GAD-7)

  12-16 weeks

• Dimensions of Anger Reactions - 5 (DAR-5)

  12-16 weeks

• Working Alliance Inventory Short Form (WAI-SF

  12-16 weeks

Study Arms (2)

HEX

ACTIVE COMPARATOR

Participants with PTSD who undergo Cognitive Processing Therapy will receive Hexadecanal molecules diffused in the therapy room.

Other: Cognitive Processing Therapy + Hexadecanal; Other: Hexadecanal - Molecule Distribution in the Therapy room

Control

PLACEBO COMPARATOR

Participants with PTSD who undergo Cognitive Processing Therapy will receive control mineral oil molecules diffused in the therapy room.

Other: Cognitive Processing Therapy + Hexadecanal; Other: Hexadecanal - Molecule Distribution in the Therapy room

Interventions

Cognitive Processing Therapy + Hexadecanal OTHER

Cognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD.

Control; HEX

Hexadecanal - Molecule Distribution in the Therapy room OTHER

Distribution of a naturally secreted molecule from body odor (Hexadecanal).

Control; HEX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tel Aviv University: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Tel Aviv University

Tel Aviv, 69978, Israel

RECRUITING

Related Publications (1)

• Endevelt-Shapira, Y. (2018). The role of chemosignaling in human social interaction (Doctoral dissertation, The Weizmann Institute of Science (Israel).

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

hexadecanal

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Yair Bar Haim, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

• Noam Sobel, PhD

  Weizmann Institute of Science

  STUDY DIRECTOR

Central Study Contacts

Yair Bar Haim, PhD

CONTACT

03-6405465; yair1@tauex.tau.ac.il

Noga Zuk Barkan

CONTACT

+972-54-6147880; nogabarkan2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The randomization list is prepared in advance. Research assistants with no contact with the patients, therapists, or independent clinical assessors operate the odor dispensers according to the randomization schedule in the designated rooms where treatments take place.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Neuroscience

Model Details: Participants will be randomly assign in a 1:1 ratio to either the active (HEX) or mineral oil (control) conditions.

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)