Post Traumatic Stress Disorder (PTSD)NCT06968312
Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD
A study testing Cognitive Processing Therapy + Hexadecanal and Hexadecanal - Molecule Distribution in the Therapy room in people with Post Traumatic Stress Disorder (PTSD), run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Cognitive Processing Therapy + Hexadecanal and Hexadecanal - Molecule Distribution in the Therapy room
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 5 May 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bipolar disorder, psychosis, neurological disorders
- Drug Addiction
- Parallel psychotherapy
- Congenital or acquired anosmia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv University
Tel Aviv, 69978
Yair Bar-Haim, PhD, 972-3-6405465, yair1@tauex.tau.ac.il
About this study
Official title: Testing Potential Enhancement of Standard Cognitive Processing Therapy for PTSD Using Hexadecanal: A Randomized Controlled Trial
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.
Read the 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)
- Being tested
- Cognitive Processing Therapy + Hexadecanal, Hexadecanal - Molecule Distribution in the Therapy room
- Keywords
- PTSD, Posttraumatic Stress Disorder, Hexadecanal, treatment, CPT, Cognitive Processing Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy + HexadecanalOther
Cognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD.
Hexadecanal - Molecule Distribution in the Therapy roomOther
Distribution of a naturally secreted molecule from body odor (Hexadecanal).
| Study group | Role | What they receive |
|---|---|---|
| HEX | Active comparator | Participants with PTSD who undergo Cognitive Processing Therapy will receive Hexadecanal molecules diffused in the therapy room. Receives: 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. Receives: Other: Cognitive Processing Therapy + Hexadecanal; Other: Hexadecanal - Molecule Distribution in the Therapy room |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist (PCL-5)
A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5
Measured: 12-16 weeks
Secondary outcomes (4)
Patient Health Questionnaire - 9 (PHQ-9)
A 9-item self-reported questionnaire on depression symptoms according to DSM-5
Measured: 12-16 weeks
Generalized Anxiety Disorder -7 (GAD-7)
A 7-item self-reported questionnaire on generalized anxiety
Measured: 12-16 weeks
Dimensions of Anger Reactions - 5 (DAR-5)
A 5-item self-reported questionnaire on anger
Measured: 12-16 weeks
Working Alliance Inventory Short Form (WAI-SF
Completed by patent and therapist - ranks the quality of therapeutic alliance
Measured: 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start5 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assign in a 1:1 ratio to either the active (HEX) or mineral oil (control) conditions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar Haim, PhD, Principal investigator, Tel Aviv UniversityNoam Sobel, PhD, Study director, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968312
- Sponsor's protocol ID
- HEX-PTSD
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Endevelt-Shapira, Y. (2018). The role of chemosignaling in human social interaction (Doctoral dissertation, The Weizmann Institute of Science (Israel).
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Potential Enhancement of Standard Cognitive Processing Therapy for PTSD Using Hexadecanal: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06968312
- Acronym / sponsor ID
- HEX-PTSD
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Keywords
- PTSD, Posttraumatic Stress Disorder, Hexadecanal, treatment, CPT, Cognitive Processing Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- 5 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assign in a 1:1 ratio to either the active (HEX) or mineral oil (control) conditions.
| Arm | Type | Receives |
|---|---|---|
| HEX | Active comparator | Other: Cognitive Processing Therapy + Hexadecanal, Other: Hexadecanal - Molecule Distribution in the Therapy roomParticipants with PTSD who undergo Cognitive Processing Therapy will receive Hexadecanal molecules diffused in the therapy room. |
| Control | Placebo comparator | Other: Cognitive Processing Therapy + Hexadecanal, Other: Hexadecanal - Molecule Distribution in the Therapy roomParticipants with PTSD who undergo Cognitive Processing Therapy will receive control mineral oil molecules diffused in the therapy room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Bipolar disorder, psychosis, neurological disorders
- Drug Addiction
- Parallel psychotherapy
- Congenital or acquired anosmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing Therapy + HexadecanalCognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD. | Other | Control, HEX |
| Hexadecanal - Molecule Distribution in the Therapy roomDistribution of a naturally secreted molecule from body odor (Hexadecanal). | Other | Control, HEX |
Primary outcome
PTSD Checklist (PCL-5)
Time frame: 12-16 weeks
A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5
4 secondary outcomes
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 12-16 weeks
Generalized Anxiety Disorder -7 (GAD-7)
Time frame: 12-16 weeks
Dimensions of Anger Reactions - 5 (DAR-5)
Time frame: 12-16 weeks
Working Alliance Inventory Short Form (WAI-SF
Time frame: 12-16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- BackgroundEndevelt-Shapira, Y. (2018). The role of chemosignaling in human social interaction (Doctoral dissertation, The Weizmann Institute of Science (Israel).
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yair Bar Haim, PhD principal investigator
Tel Aviv University
Noam Sobel, PhD study director
Weizmann Institute of Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy + Hexadecanal and Hexadecanal - Molecule Distribution in the Therapy room in people with Post Traumatic Stress Disorder (PTSD), run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yair Bar Haim, PhD (03-6405465, yair1@tauex.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL-5) (time frame: 12-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.