Posttraumatic Stress DisorderNCT06348472
The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness
An observational study of Posttraumatic Stress Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Mar 2024to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients demonstrating PTSD symptoms following a traumatic event, seeking psychotherapy treatment in Shalvata Mental Health Center's trauma clinic.
Who may be able to join
- Minimum score of 33 on the PTSD symptoms questionnaire (PCL-5).
- Anticipated 12-24 psychotherapy sessions.
Who cannot join
- Psychotic episode.
- Female patients: pregnancy or breastfeeding (according to self-report).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Shalvata Mental health Center
Hod HaSharon
Omer Sedoff, MA, omerse@clalit.org.il
About this study
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
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin Secretion
Endogenous oxytocin level in saliva
Measured: 12-16 weeks, depending on treatment duration
Inflammatory Response: IL-1β
inflammatory biomarker IL-1β assessed in saliva
Measured: 12-16 weeks, depending on treatment duration
Inflammatory Response: IL-6
inflammatory biomarker IL-6 assessed in saliva
Measured: 12-16 weeks, depending on treatment duration
Inflammatory Response: TNF-α
inflammatory biomarker TNF-α assessed in saliva
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-16 weeks, depending on treatment duration
Secondary outcomes (2)
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.
Measured: 12-16 weeks, depending on treatment duration
Working Alliance
Short Alliance Inventory (SAI): Self-report questionnaire consisting of 6 items ranging from 0-5. High scores indicate better outcome.
Measured: 12-16 weeks, depending on treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start14 Mar 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuval Bloch, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348472
- Sponsor's protocol ID
- 0004-24-SHA
- Status last verified
- Jun 2024
- First submitted
- 17 Mar 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness
- ClinicalTrials.gov ID
- NCT06348472
- Acronym / sponsor ID
- 0004-24-SHA
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients demonstrating PTSD symptoms following a traumatic event, seeking psychotherapy treatment in Shalvata Mental Health Center's trauma clinic.
Key inclusion criteria (2 listed)
- Minimum score of 33 on the PTSD symptoms questionnaire (PCL-5).
- Anticipated 12-24 psychotherapy sessions.
Key exclusion criteria (2 listed)
- Psychotic episode.
- Female patients: pregnancy or breastfeeding (according to self-report).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxytocin Secretion
Time frame: 12-16 weeks, depending on treatment duration
Endogenous oxytocin level in saliva
Inflammatory Response: IL-1β
Time frame: 12-16 weeks, depending on treatment duration
inflammatory biomarker IL-1β assessed in saliva
Inflammatory Response: IL-6
Time frame: 12-16 weeks, depending on treatment duration
inflammatory biomarker IL-6 assessed in saliva
Inflammatory Response: TNF-α
Time frame: 12-16 weeks, depending on treatment duration
inflammatory biomarker TNF-α assessed in saliva
Posttraumatic stress disorder symptoms
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.
Depression severity
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.
General anxiety symptoms
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.
2 secondary outcomes
Psychological resilience
Time frame: 12-16 weeks, depending on treatment duration
Working Alliance
Time frame: 12-16 weeks, depending on treatment duration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omer Sedoff, MA (97297478555, omerse@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxytocin Secretion (time frame: 12-16 weeks, depending on treatment duration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.