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

NCT06348472 | Recruiting

• 1 other identifier: 0004-24-SHA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Oxytocin Secretion

  Endogenous oxytocin level in saliva

  12-16 weeks, depending on treatment duration

• Inflammatory Response: IL-1β

  inflammatory biomarker IL-1β assessed in saliva

  12-16 weeks, depending on treatment duration

• Inflammatory Response: IL-6

  inflammatory biomarker IL-6 assessed in saliva

  12-16 weeks, depending on treatment duration

• Inflammatory Response: TNF-α

  inflammatory biomarker TNF-α assessed in saliva

  12-16 weeks, depending on treatment duration

• 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

• 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

• 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 Outcomes (2)

• Psychological resilience

  12-16 weeks, depending on treatment duration

• Working Alliance

  12-16 weeks, depending on treatment duration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Minimum score of 33 on the PTSD symptoms questionnaire (PCL-5).
• Anticipated 12-24 psychotherapy sessions.

You may not qualify if:

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

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata Mental health Center

Hod HaSharon, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oxytocin and inflammatory biomarkers will be measured in saliva according to guidelines (Zilcha-Mano et al., 2020; Szabo \& Slavish, 2021). The following inflammatory biomarkers will be assessed due to previously established associations with PTSD: IL-1β, IL-6, TNF-α, and CRP (Hori \& Kim, 2019).

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Omer Sedoff, MA

CONTACT

97297478555; omerse@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 4, 2024
• Study Start: March 14, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

IL (1)