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| Name | Class |
|---|---|
| Weizmann Institute of Science | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEX | Active Comparator | Participants with PTSD who undergo Cognitive Processing Therapy will receive Hexadecanal molecules diffused in the therapy room. |
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| Control | Placebo Comparator | Participants with PTSD who undergo Cognitive Processing Therapy will receive control mineral oil molecules diffused in the therapy room. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Processing Therapy + Hexadecanal | Other | Cognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD. |
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| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist (PCL-5) | A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5 | 12-16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire - 9 (PHQ-9) | A 9-item self-reported questionnaire on depression symptoms according to DSM-5 | 12-16 weeks |
| Generalized Anxiety Disorder -7 (GAD-7) | A 7-item self-reported questionnaire on generalized anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yair Bar Haim, PhD | Contact | 03-6405465 | yair1@tauex.tau.ac.il | |
| Noga Zuk Barkan | Contact | +972-54-6147880 | nogabarkan2@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yair Bar Haim, PhD | Tel Aviv University | Principal Investigator |
| Noam Sobel, PhD | Weizmann Institute of Science | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv University | Recruiting | Tel Aviv | 69978 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Endevelt-Shapira, Y. (2018). The role of chemosignaling in human social interaction (Doctoral dissertation, The Weizmann Institute of Science (Israel). |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C001647 | hexadecanal |
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Participants will be randomly assign in a 1:1 ratio to either the active (HEX) or mineral oil (control) conditions.
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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.
| Hexadecanal - Molecule Distribution in the Therapy room | Other | Distribution of a naturally secreted molecule from body odor (Hexadecanal). |
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| 12-16 weeks |
| Dimensions of Anger Reactions - 5 (DAR-5) | A 5-item self-reported questionnaire on anger | 12-16 weeks |
| Working Alliance Inventory Short Form (WAI-SF | Completed by patent and therapist - ranks the quality of therapeutic alliance | 12-16 weeks |