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NCT Number: NCT06348472

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shalvata Mental health Center

Hod HaSharon, Israel

Location status: Recruiting

Location contact

Omer Sedoff, MA

CONTACT

[email protected]

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Oxytocin Secretion

    Time frame: 12-16 weeks, depending on treatment duration

    Endogenous oxytocin level in saliva

  2. Inflammatory Response: IL-1β

    Time frame: 12-16 weeks, depending on treatment duration

    inflammatory biomarker IL-1β assessed in saliva

  3. Inflammatory Response: IL-6

    Time frame: 12-16 weeks, depending on treatment duration

    inflammatory biomarker IL-6 assessed in saliva

  4. Inflammatory Response: TNF-α

    Time frame: 12-16 weeks, depending on treatment duration

    inflammatory biomarker TNF-α assessed in saliva

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Psychological resilience

    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.

  2. Working Alliance

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Omer Sedoff, MA

CONTACT

[email protected]

97297478555

Sponsors and collaborators

Lead sponsor

Shalvata Mental Health Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 4, 2024
Registry last updated
Jun 28, 2024

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.

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