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

NCT06348472 — Recruiting, 100 participants, Shalvata Mental Health Center

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Registry	NCT06348472
Status	Recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Shalvata Mental Health Center (Other)
Conditions	Posttraumatic Stress Disorder
Dates	start 2024-03-14, primary completion 2028-03-01 (estimated), completion 2028-03-01 (estimated), first posted 2024-04-04, last updated 2024-06-28
Locations	1 site in Israel

-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.

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+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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).

+Locations (1)

Facility	City	Country	Status
Shalvata Mental health Center	Hod HaSharon	Israel	Recruiting

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