Shalvata Mental health Center
Hod HaSharon, Israel
Location status: Recruiting
NCT Number: NCT06348472
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Hod HaSharon, Israel
Location status: Recruiting
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12-16 weeks, depending on treatment duration
Endogenous oxytocin level in saliva
Time frame: 12-16 weeks, depending on treatment duration
inflammatory biomarker IL-1β assessed in saliva
Time frame: 12-16 weeks, depending on treatment duration
inflammatory biomarker IL-6 assessed in saliva
Time frame: 12-16 weeks, depending on treatment duration
inflammatory biomarker TNF-α assessed in saliva
Time frame: 12-16 weeks, depending on treatment duration
PTSD checklist for DSM-5 (PCL-5): Self-report questionnaire consisting of 20 items ranging from 0-4. High scores indicate worst outcome.
Time frame: 12-16 weeks, depending on treatment duration
Patient health questionnaire (PHQ-9): Self-report questionnaire consisting of 9 items ranging from 0-3. High scores indicate worst outcome.
Time frame: 12-16 weeks, depending on treatment duration
Generalized anxiety disorder (GAD-7): Self-report questionnaire consisting of 7 items ranging from 0-3. High scores indicate worst outcome.
Time frame: 12-16 weeks, depending on treatment duration
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
Short Alliance Inventory (SAI): Self-report questionnaire consisting of 6 items ranging from 0-5. High scores indicate better outcome.
Contact information is provided by the study sponsor or research team.
Shalvata Mental Health Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05624931
Behavior, Behavioral Symptoms
Boston, Massachusetts, United States
View Trial DetailsNCT06449326
Mental Disorders, Posttraumatic Stress Disorder
Albuquerque, New Mexico, United States
View Trial DetailsNCT07250061
Behavior, Behavioral Symptoms
Boston, Massachusetts, United States
View Trial DetailsNCT06288711
Chemically-Induced Disorders, Mental Disorders
Burlington, Vermont, United States
View Trial Details