Sensory Modulation Dysfunction and Posttraumatic Stress Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Posttraumatic Stress Disorder Sensory Processing Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial with an experimental group and a control group: Specifically participants will be screened for SMD, thereafter randomization will be applied within each group: with and without SMD, separately.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Assessors will be blind to group allocation

Study Groups

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traumatic (scenes of injury and death during combat)

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.

Group Type EXPERIMENTAL

The Trauma Film Paradigm

Intervention Type BEHAVIORAL

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").

non-traumatic (neutral) film

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").

Group Type ACTIVE_COMPARATOR

non-traumatic (neutral) film

Intervention Type BEHAVIORAL

non-traumatic (neutral) film

Interventions

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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").

Intervention Type BEHAVIORAL

non-traumatic (neutral) film

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes