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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348472
• Other study ID #: 0004-24-SHA
• Status: Recruiting
• Start date: March 14, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: March 2024
• Source: Shalvata Mental Health Center
• Contact: Omer Sedoff, MA
• Phone: 972525708722
• Email: omer[@]clalit.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2028
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
Israel	Shalvata Mental health Center	Hod HaSharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxytocin Secretion	Endogenous oxytocin level in saliva	12-16 weeks, depending on treatment duration
Primary	Inflammatory Response: IL-1ß	inflammatory biomarker IL-1ß assessed in saliva	12-16 weeks, depending on treatment duration
Primary	Inflammatory Response: IL-6	inflammatory biomarker IL-6 assessed in saliva	12-16 weeks, depending on treatment duration
Primary	Inflammatory Response: TNF-a	inflammatory biomarker TNF-a assessed in saliva	12-16 weeks, depending on treatment duration
Primary	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
Primary	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
Primary	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	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
Secondary	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