Post Traumatic Stress Disorder (PTSD)
Conditions
Keywords
PTSD, Posttraumatic Stress Disorder, Hexadecanal, treatment, CPT, Cognitive Processing Therapy
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).
Interventions
OTHERCognitive Processing Therapy + Hexadecanal
Cognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD.
OTHERHexadecanal - Molecule Distribution in the Therapy room
Distribution of a naturally secreted molecule from body odor (Hexadecanal).
Sponsors
Weizmann Institute of Science
Tel Aviv University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assign in a 1:1 ratio to either the active (HEX) or mineral oil (control) conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist (PCL-5) | 12-16 weeks | A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire - 9 (PHQ-9) | 12-16 weeks | A 9-item self-reported questionnaire on depression symptoms according to DSM-5 |
| Generalized Anxiety Disorder -7 (GAD-7) | 12-16 weeks | A 7-item self-reported questionnaire on generalized anxiety |
| Dimensions of Anger Reactions - 5 (DAR-5) | 12-16 weeks | A 5-item self-reported questionnaire on anger |
| Working Alliance Inventory Short Form (WAI-SF | 12-16 weeks | Completed by patent and therapist - ranks the quality of therapeutic alliance |
Countries
Israel
Contacts
Primary ContactYair Bar Haim, PhD
Backup ContactNoga Zuk Barkan
Outcome results
None listed