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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShalvata Mental Health Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Minimum score of 33 on the PTSD symptoms questionnaire (PCL-5).

Anticipated 12-24 psychotherapy sessions.

Disqualifiers

Psychotic episode.

Female patients: pregnancy or breastfeeding (according to self-report).

Trial population

Patients demonstrating PTSD symptoms following a traumatic event, seeking psychotherapy treatment in Shalvata Mental Health Center's trauma clinic.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Oxytocin Secretion

Endogenous oxytocin level in saliva

Time frame
12-16 weeks, depending on treatment duration
2

Inflammatory Response: IL-1β

inflammatory biomarker IL-1β assessed in saliva

Time frame
12-16 weeks, depending on treatment duration
3

Inflammatory Response: IL-6

inflammatory biomarker IL-6 assessed in saliva

Time frame
12-16 weeks, depending on treatment duration
4

Inflammatory Response: TNF-α

inflammatory biomarker TNF-α assessed in saliva

Time frame
12-16 weeks, depending on treatment duration

Secondary outcomes

1

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.

Time frame
12-16 weeks, depending on treatment duration
2

Working Alliance

Short Alliance Inventory (SAI): Self-report questionnaire consisting of 6 items ranging from 0-5. High scores indicate better outcome.

Time frame
12-16 weeks, depending on treatment duration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.