Clinical trial NCT06968312: Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD
Official title: Testing Potential Enhancement of Standard Cognitive Processing Therapy for PTSD Using Hexadecanal: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder (PTSD)
Keywords: PTSD
Posttraumatic Stress Disorder
Hexadecanal
treatment
CPT
Cognitive Processing Therapy
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
First posted: 2025-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assign in a 1:1 ratio to either the active (HEX) or mineral oil (control) conditions.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: PTSD Checklist (PCL-5)
timeFrame: 12-16 weeks
Secondary outcomes:
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 12-16 weeks
measure: Generalized Anxiety Disorder -7 (GAD-7)
timeFrame: 12-16 weeks
measure: Dimensions of Anger Reactions - 5 (DAR-5)
timeFrame: 12-16 weeks
measure: Working Alliance Inventory Short Form (WAI-SF
timeFrame: 12-16 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar Haim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weizmann Institute of Science
name: Noam Sobel, PhD
role: STUDY_DIRECTOR
References:
citation: Endevelt-Shapira, Y. (2018). The role of chemosignaling in human social interaction (Doctoral dissertation, The Weizmann Institute of Science (Israel).