NCT05967962

Sensory Modulation Dysfunction and Posttraumatic Stress Disorder

Sensory Modulation Dysfunction as a Risk Factor for Posttraumatic Stress Disorder - A Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Tel Aviv University · Academic / Other
• Sex: All
• Age: 18 Years – 28 Years
• Healthy volunteers: Accepted

Summary

To explore the role of sensory modulation dysfunction (SMD) (i.e., a neurodevelopmental state altering the sensory perception, severely interfering with daily function) as a risk factor for posttraumatic stress disorder (PTSD), its co-occurring pain, and impeded cognitive functions, following exposure to combat trauma.

Detailed description

Background and Aim: Posttraumatic stress disorder (PTSD) is interwoven with chronic pain, and the latter co-occurs with sensory modulation dysfunction (SMD). Moreover, SMD was found as a risk factor for chronic pain and hampered executive functioning. Currently, the sensory domain is neglected in the PTSD research realm, though findings indicate its link to PTSD. Thus, this study proposes to bridge a current gap in PTSD knowledge base, and specifically, our general aim is to uncover the role of SMD in predicting combat trauma-related symptomatology, altered executive function, and clinical pain. Methods: This is a single-blind randomized control study, comprising 4 assessments: pre (T1); post (T2); 10 (T3); and 40 (T4) days follow-up, following experimental manipulation (see Figure 1). Participants with and without SMD will be randomly allocated to experimental and control groups that will watch traumatic movie scenes simulating combat and non-traumatic movie scenes, respectively. The assessor will be blinded to group allocation. Population: One-hundred healthy individuals aged 18 to 28 years, with and without SMD. Participants with SMD will be identified via a standardized questionnaire during screening. The sample size was calculated based on power analyses via G\*Power 3 software derived from p-value of .05 and statistical power of .80. Tools: Both objective and subjective outcome measures will be applied consisting of self-report questionnaires, psychophysical-, physiological-, emotional reactions, and executive function performance-based- testing will be applied. The experimental manipulation will comprise of the Trauma film paradigm. Expected Results: Findings may advance the understanding of PTSD development and thus not only serve in attenuating the risk for PTSD among combatants but also may contribute to developing preventative measures for PTSD among combatants.

Conditions

• Posttraumatic Stress Disorder
• Sensory Processing Disorder

Interventions

Type	Name	Description
BEHAVIORAL	The Trauma Film Paradigm	Trauma film paradigm is a well-known, validated and established procedure that produces reactions similar to those generated by trauma, and that is often used in research to predict susceptibility for peritraumatic and posttraumatic reactions. In this study the trauma film paradigm will be utilized to simulate combat exposure. The two groups of participants will undergo the trauma film paradigm by watching 16 min traumatic combat scenes vs. non-traumatic movie scenes, respectively. Participants will be given standardized instructions (i.e., ''Imagine you are present at the scene"; "Do not close your eyes").
BEHAVIORAL	non-traumatic (neutral) film	non-traumatic (neutral) film

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2023-08-01
• Last updated: 2026-03-10

Locations

1 site across 1 country: Israel