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Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD

ConditionPost Traumatic Stress Disorder (PTSD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTel Aviv University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Bipolar disorder, psychosis, neurological disorders

Drug Addiction

Parallel psychotherapy

Congenital or acquired anosmia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive Processing Therapy + Hexadecanal

    Other intervention

    Cognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD.

  • Hexadecanal - Molecule Distribution in the Therapy room

    Other intervention

    Distribution of a naturally secreted molecule from body odor (Hexadecanal).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: HEXActive comparator 2 interventions
Group B: ControlPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

PTSD Checklist (PCL-5)

A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5

Time frame
12-16 weeks

Secondary outcomes

1

Patient Health Questionnaire - 9 (PHQ-9)

A 9-item self-reported questionnaire on depression symptoms according to DSM-5

Time frame
12-16 weeks
2

Generalized Anxiety Disorder -7 (GAD-7)

A 7-item self-reported questionnaire on generalized anxiety

Time frame
12-16 weeks
3

Dimensions of Anger Reactions - 5 (DAR-5)

A 5-item self-reported questionnaire on anger

Time frame
12-16 weeks
4

Working Alliance Inventory Short Form (WAI-SF

Completed by patent and therapist - ranks the quality of therapeutic alliance

Time frame
12-16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tel Aviv University

Lead sponsor

Weizmann Institute of Science

Collaborator

Source ClinicalTrials.gov
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