Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD

NCT ID: NCT06968312

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2026-12-30

Brief Summary

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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

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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

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Post Traumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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HEX

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

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy + Hexadecanal

Intervention Type OTHER

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

Hexadecanal - Molecule Distribution in the Therapy room

Intervention Type OTHER

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

Control

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

Group Type PLACEBO_COMPARATOR

Cognitive Processing Therapy + Hexadecanal

Intervention Type OTHER

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

Hexadecanal - Molecule Distribution in the Therapy room

Intervention Type OTHER

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

Interventions

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Cognitive Processing Therapy + Hexadecanal

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

Intervention Type OTHER

Hexadecanal - Molecule Distribution in the Therapy room

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weizmann Institute of Science

OTHER

Sponsor Role collaborator

Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Yair Bar-Haim

Professor of Psychology and Neuroscience

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yair Bar Haim, PhD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Noam Sobel, PhD

Role: STUDY_DIRECTOR

Weizmann Institute of Science

Locations

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Tel Aviv University

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yair Bar Haim, PhD

Role: CONTACT

03-6405465

Noga Zuk Barkan

Role: CONTACT

+972-54-6147880

Facility Contacts

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Yair Bar-Haim, PhD

Role: primary

972-3-6405465

References

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

Reference Type BACKGROUND

Other Identifiers

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HEX-PTSD

Identifier Type: -

Identifier Source: org_study_id

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