RecruitingNCT06348472

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


Sponsor

Shalvata Mental Health Center

Enrollment

100 participants

Start Date

Mar 14, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether certain immune and inflammatory markers in the blood — and their relationship to oxytocin (a hormone involved in stress and social bonding) — can predict how well a person with PTSD will respond to psychotherapy. The goal is to help doctors better personalize trauma treatment. **You may be eligible if...** - You have significant PTSD symptoms (a PCL-5 questionnaire score of 33 or higher) - You are scheduled to receive 12–24 sessions of psychotherapy **You may NOT be eligible if...** - You have experienced a psychotic episode - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Shalvata Mental health Center

Hod HaSharon, Israel

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NCT06348472


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