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

Recruiting

• Conditions: Posttraumatic Stress Disorder

• Registration Number: NCT06348472
• Lead Sponsor: Shalvata Mental Health Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-14
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-31
• Study First Posted: 2024-04-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2028-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxytocin Secretion	12-16 weeks, depending on treatment duration	Endogenous oxytocin level in saliva
Inflammatory Response: IL-6	12-16 weeks, depending on treatment duration	inflammatory biomarker IL-6 assessed in saliva
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.
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.
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.
Inflammatory Response: IL-1β	12-16 weeks, depending on treatment duration	inflammatory biomarker IL-1β assessed in saliva

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shalvata Mental health Center; 🇮🇱 Hod HaSharon, Israel