The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness

Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Omer Sedoff, MA; Phone Number: 97297478555; Email: omerse@clalit.org.il

Study Locations

• Israel
  • Hod HaSharon, Israel
    • Recruiting
    • Shalvata Mental Health Center
    • Contact: Omer Sedoff, MA; Email: omerse@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients demonstrating PTSD symptoms following a traumatic event, seeking psychotherapy treatment in Shalvata Mental Health Center's trauma clinic.

Description

Inclusion Criteria:

• Minimum score of 33 on the PTSD symptoms questionnaire (PCL-5).
• Anticipated 12-24 psychotherapy sessions.

Exclusion Criteria:

• Psychotic episode.
• Female patients: pregnancy or breastfeeding (according to self-report).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxytocin Secretion	Endogenous oxytocin level in saliva	12-16 weeks, depending on treatment duration
Inflammatory Response: IL-1β	inflammatory biomarker IL-1β assessed in saliva	12-16 weeks, depending on treatment duration
Inflammatory Response: IL-6	inflammatory biomarker IL-6 assessed in saliva	12-16 weeks, depending on treatment duration
Inflammatory Response: TNF-α	inflammatory biomarker TNF-α assessed in saliva	12-16 weeks, depending on treatment duration
Posttraumatic stress disorder symptoms	PTSD checklist for DSM-5 (PCL-5): Self-report questionnaire consisting of 20 items ranging from 0-4. High scores indicate worst outcome.	12-16 weeks, depending on treatment duration
Depression severity	Patient health questionnaire (PHQ-9): Self-report questionnaire consisting of 9 items ranging from 0-3. High scores indicate worst outcome.	12-16 weeks, depending on treatment duration
General anxiety symptoms	Generalized anxiety disorder (GAD-7): Self-report questionnaire consisting of 7 items ranging from 0-3. High scores indicate worst outcome.	12-16 weeks, depending on treatment duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological resilience	Conor-Davidson resilience scale (CD-RISC-10): Self-report questionnaire consisting of 10 items ranging from 0-4. High scores indicate better outcome.	12-16 weeks, depending on treatment duration
Working Alliance	Short Alliance Inventory (SAI): Self-report questionnaire consisting of 6 items ranging from 0-5. High scores indicate better outcome.	12-16 weeks, depending on treatment duration

Collaborators and Investigators

• Sponsor: Shalvata Mental Health Center
• Investigators: Principal Investigator: Hagai Maoz, MD, Shalvata Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 0004-24-SHA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No