Clinical trial NCT06348472: The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness
Official title: The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients demonstrating PTSD symptoms following a traumatic event, seeking psychotherapy treatment in Shalvata Mental Health Center's trauma clinic.

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.


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).

Primary outcomes:
measure: Oxytocin Secretion
timeFrame: 12-16 weeks, depending on treatment duration
measure: Inflammatory Response: IL-1β
timeFrame: 12-16 weeks, depending on treatment duration
measure: Inflammatory Response: IL-6
timeFrame: 12-16 weeks, depending on treatment duration
measure: Inflammatory Response: TNF-α
timeFrame: 12-16 weeks, depending on treatment duration
measure: Posttraumatic stress disorder symptoms
timeFrame: 12-16 weeks, depending on treatment duration
measure: Depression severity
timeFrame: 12-16 weeks, depending on treatment duration
measure: General anxiety symptoms
timeFrame: 12-16 weeks, depending on treatment duration
Secondary outcomes:
measure: Psychological resilience
timeFrame: 12-16 weeks, depending on treatment duration
measure: Working Alliance
timeFrame: 12-16 weeks, depending on treatment duration
Other outcomes:
Locations:
city: Hod HaSharon
country: Israel
facility: Shalvata Mental health Center
Study officials:
References: