Testing Potential Enhancement of Standard Cognitive Processing Therapy for PTSD Using Hexadecanal: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tel Aviv University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- PTSD Checklist (PCL-5)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
HEX
Participants with PTSD who undergo Cognitive Processing Therapy will receive Hexadecanal molecules diffused in the therapy room.
Intervention: Cognitive Processing Therapy + Hexadecanal (Other)
HEX
Participants with PTSD who undergo Cognitive Processing Therapy will receive Hexadecanal molecules diffused in the therapy room.
Intervention: Hexadecanal - Molecule Distribution in the Therapy room (Other)
Control
Participants with PTSD who undergo Cognitive Processing Therapy will receive control mineral oil molecules diffused in the therapy room.
Intervention: Cognitive Processing Therapy + Hexadecanal (Other)
Control
Participants with PTSD who undergo Cognitive Processing Therapy will receive control mineral oil molecules diffused in the therapy room.
Intervention: Hexadecanal - Molecule Distribution in the Therapy room (Other)
Outcomes
Primary Outcomes
PTSD Checklist (PCL-5)
Time Frame: 12-16 weeks
A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5
Secondary Outcomes
- Dimensions of Anger Reactions - 5 (DAR-5)(12-16 weeks)
- Patient Health Questionnaire - 9 (PHQ-9)(12-16 weeks)
- Generalized Anxiety Disorder -7 (GAD-7)(12-16 weeks)
- Working Alliance Inventory Short Form (WAI-SF(12-16 weeks)
Investigators
Yair Bar-Haim
Professor of Psychology and Neuroscience
Tel Aviv University