Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-01-01 @ 5:50 AM
Study NCT ID:
NCT06968312
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C001647', 'term': 'hexadecanal'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assign in a 1:1 ratio to either the active (HEX) or mineral oil (control) conditions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2025-05-05', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PTSD Checklist (PCL-5)', 'timeFrame': '12-16 weeks', 'description': 'A 20-item self-reported questionnaire on PTSD symptoms according to DSM-5'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire - 9 (PHQ-9)', 'timeFrame': '12-16 weeks', 'description': 'A 9-item self-reported questionnaire on depression symptoms according to DSM-5'}, {'measure': 'Generalized Anxiety Disorder -7 (GAD-7)', 'timeFrame': '12-16 weeks', 'description': 'A 7-item self-reported questionnaire on generalized anxiety'}, {'measure': 'Dimensions of Anger Reactions - 5 (DAR-5)', 'timeFrame': '12-16 weeks', 'description': 'A 5-item self-reported questionnaire on anger'}, {'measure': 'Working Alliance Inventory Short Form (WAI-SF', 'timeFrame': '12-16 weeks', 'description': 'Completed by patent and therapist - ranks the quality of therapeutic alliance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'Posttraumatic Stress Disorder', 'Hexadecanal', 'treatment', 'CPT', 'Cognitive Processing Therapy'], 'conditions': ['Post Traumatic Stress Disorder (PTSD)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Endevelt-Shapira, Y. (2018). The role of chemosignaling in human social interaction (Doctoral dissertation, The Weizmann Institute of Science (Israel).'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of PTSD according to DSM-5\n* Age 18 years and over\n* Eligible for CPT treatment at the National Center for Traumatic Stress and Resilience\n\nExclusion Criteria:\n\n* Bipolar disorder, psychosis, neurological disorders\n* Drug Addiction\n* Parallel psychotherapy\n* Congenital or acquired anosmia.'}, 'identificationModule': {'nctId': 'NCT06968312', 'briefTitle': 'Hexadecanal as an Addon to Cognitive Processing Therapy for PTSD', 'organization': {'class': 'OTHER', 'fullName': 'Tel Aviv University'}, 'officialTitle': 'Testing Potential Enhancement of Standard Cognitive Processing Therapy for PTSD Using Hexadecanal: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HEX-PTSD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HEX', 'description': 'Participants with PTSD who undergo Cognitive Processing Therapy will receive Hexadecanal molecules diffused in the therapy room.', 'interventionNames': ['Other: Cognitive Processing Therapy + Hexadecanal', 'Other: Hexadecanal - Molecule Distribution in the Therapy room']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Participants with PTSD who undergo Cognitive Processing Therapy will receive control mineral oil molecules diffused in the therapy room.', 'interventionNames': ['Other: Cognitive Processing Therapy + Hexadecanal', 'Other: Hexadecanal - Molecule Distribution in the Therapy room']}], 'interventions': [{'name': 'Cognitive Processing Therapy + Hexadecanal', 'type': 'OTHER', 'description': 'Cognitive Processing Therapy is a protocolized, trauma-focused, CBT type treatment for PTSD.', 'armGroupLabels': ['Control', 'HEX']}, {'name': 'Hexadecanal - Molecule Distribution in the Therapy room', 'type': 'OTHER', 'description': 'Distribution of a naturally secreted molecule from body odor (Hexadecanal).', 'armGroupLabels': ['Control', 'HEX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69978', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yair Bar-Haim, PhD', 'role': 'CONTACT', 'email': 'yair1@tauex.tau.ac.il', 'phone': '972-3-6405465'}], 'facility': 'Tel Aviv University', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Yair Bar Haim, PhD', 'role': 'CONTACT', 'email': 'yair1@tauex.tau.ac.il', 'phone': '03-6405465'}, {'name': 'Noga Zuk Barkan', 'role': 'CONTACT', 'email': 'nogabarkan2@gmail.com', 'phone': '+972-54-6147880'}], 'overallOfficials': [{'name': 'Yair Bar Haim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv University'}, {'name': 'Noam Sobel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Weizmann Institute of Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel Aviv University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weizmann Institute of Science', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology and Neuroscience', 'investigatorFullName': 'Yair Bar-Haim', 'investigatorAffiliation': 'Tel Aviv University'}}}}