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

NCT ID: NCT06348472

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2028-03-01

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shalvata Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Yuval Bloch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shalvata Mental health Center

Hod HaSharon, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Omer Sedoff, MA

Role: CONTACT

omerse@clalit.org.il

97297478555

Facility Contacts

Omer Sedoff, MA

Role: primary

omerse@clalit.org.il

Other Identifiers

0004-24-SHA

Identifier Type: -

Identifier Source: org_study_id