Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD

Tel Aviv University

Status: Enrolling

Conditions: Post Traumatic Stress Disorder (PTSD)

Treatments: Other: Hexadecanal - Molecule Distribution in the Therapy room; Other: Cognitive Processing Therapy + Hexadecanal

Study type: Interventional

Funder types: Other

Identifiers

NCT06968312

HEX-PTSD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

HEX

Active Comparator group

Description:

Participants with PTSD who undergo Cognitive Processing Therapy will receive Hexadecanal molecules diffused in the therapy room.

Treatment:

Other: Cognitive Processing Therapy + Hexadecanal

Other: Hexadecanal - Molecule Distribution in the Therapy room

Control

Placebo Comparator group

Description:

Participants with PTSD who undergo Cognitive Processing Therapy will receive control mineral oil molecules diffused in the therapy room.

Treatment:

Other: Cognitive Processing Therapy + Hexadecanal

Other: Hexadecanal - Molecule Distribution in the Therapy room