Sensory Modulation Dysfunction and Posttraumatic Stress Disorder

Tel Aviv University

Status: Enrolling

Conditions: Sensory Processing Disorder; Posttraumatic Stress Disorder

Treatments: Behavioral: non-traumatic (neutral) film; Behavioral: The Trauma Film Paradigm

Study type: Interventional

Funder types: Other

Identifiers

NCT05967962

0005364-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Intact or corrected vision
• Proficiency in Hebrew
• Exclusion Criteria:
• Neurological disorders
• Psychiatric disorders
• Neurodevelopmental disorders
• Substance use disorder
• Chronic pain
• Regular intake of medications.
• Cultural and societal backgrounds that might bias participant reaction to study protocol (i.e., nationality)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

traumatic (scenes of injury and death during combat)

Experimental group

Description:

In the experimental group participants will be exposed to a traumatic scene, to simulate combat exposure by watching 16 min traumatic combat scenes from the TV series "When Heroes Fly.

Treatment:

Behavioral: The Trauma Film Paradigm

non-traumatic (neutral) film

Active Comparator group

Description:

In this active control group, participants will be watching 16 min. non-traumatic, neutral scene showing combatants as well (scenes from the YouTube series "Warriors").

Treatment:

Behavioral: non-traumatic (neutral) film