Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Processing Therapy + Hexadecanal, Hexadecanal - Molecule Distribution in the Therapy room.
- Who it may be relevant to
- Registry conditions: Post Traumatic Stress Disorder (PTSD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Testing Potential Enhancement of Standard Cognitive Processing Therapy for PTSD Using Hexadecanal: A Randomized Controlled Trial
Overview
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).
Interventions
- Other Cognitive Processing Therapy + Hexadecanal
Cognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD. - Other Hexadecanal - Molecule Distribution in the Therapy room
Distribution of a naturally secreted molecule from body odor (Hexadecanal).
Primary outcome measures
- PTSD Checklist (PCL-5) [Time frame: 12-16 weeks]
Secondary outcome measures (4)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Tel Aviv University — Tel Aviv
Publications
- Endevelt-Shapira, Y. (2018). The role of chemosignaling in human social interaction (Doctoral dissertation, The Weizmann Institute of Science (Israel).
Identifiers
NCT: NCT06968312 · HEX-PTSD