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NCT Number: NCT06968312

Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD

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.

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Key information

Conditions

Post Traumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Processing Therapy + Hexadecanal

Other

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

Hexadecanal - Molecule Distribution in the Therapy room

Other

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

Primary outcomes

  1. PTSD Checklist (PCL-5)

    Time frame: 12-16 weeks

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

Secondary outcomes

  1. Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: 12-16 weeks

    A 9-item self-reported questionnaire on depression symptoms according to DSM-5

  2. Generalized Anxiety Disorder -7 (GAD-7)

    Time frame: 12-16 weeks

    A 7-item self-reported questionnaire on generalized anxiety

  3. Dimensions of Anger Reactions - 5 (DAR-5)

    Time frame: 12-16 weeks

    A 5-item self-reported questionnaire on anger

  4. Working Alliance Inventory Short Form (WAI-SF

    Time frame: 12-16 weeks

    Completed by patent and therapist - ranks the quality of therapeutic alliance

Study contacts

Contact information is provided by the study sponsor or research team.

Noga Zuk Barkan

CONTACT

[email protected]

+972-54-6147880

Yair Bar Haim, PhD

CONTACT

[email protected]

03-6405465

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

  • Weizmann Institute of Science

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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