The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Disorder. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Oxytocin Secretion [Time frame: 12-16 weeks, depending on treatment duration]
- Inflammatory Response: IL-1β [Time frame: 12-16 weeks, depending on treatment duration]
- Inflammatory Response: IL-6 [Time frame: 12-16 weeks, depending on treatment duration]
- Inflammatory Response: TNF-α [Time frame: 12-16 weeks, depending on treatment duration]
- Posttraumatic stress disorder symptoms [Time frame: 12-16 weeks, depending on treatment duration]
- Depression severity [Time frame: 12-16 weeks, depending on treatment duration]
- General anxiety symptoms [Time frame: 12-16 weeks, depending on treatment duration]
Secondary outcome measures (2)
- Psychological resilience [Time frame: 12-16 weeks, depending on treatment duration]
- Working Alliance [Time frame: 12-16 weeks, depending on treatment duration]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Israel · 1 center
- Shalvata Mental health Center — Hod HaSharon
Identifiers
NCT: NCT06348472 · 0004-24-SHA