Sensory Modulation Dysfunction and Posttraumatic Stress Disorder

NCT05967962 | Completed

• 1 other identifier: 0005364-2
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sensory Processing Disorder; Posttraumatic Stress Disorder

Keywords

sensory processing; executive function; trauma; peritrauma

Outcome Measures

Primary Outcomes (2)

• Pain Sensitivity Questionnaire (PSQ)

  A 17 item self-report questionnaire assessing daily pain sensitivity, aimed to quantify everyday somatosensory pain sensitivity to imagined painful daily life situations. Participants rate the intensity of imagined pain on a 10-point scale: 'not painful at all' (0) to 'the worst pain imaginable' (10). The Pain Sensitivity Questionnaire provides a total score (range 17-170) and two sub-scores.

  Change from immediately before and immediately after the manipulation and 40 days post undertaking the manipulation

• Spontaneously occurring memories

  Diaries will be utilized for reporting spontaneously occurring memories of the film, consisting of 6 items of which 1 is an open question. This will be filled once a day for 6 days starting the next day after the trauma film paradigm was undertaken. Thereafter, it will be filled in again in T3 and T4

  Change between T2, T3, T4: SpecificallyT2-during 6 days, starting the day after undertaking the experiment = trauma film paradigm, 10 (T3); and 40 (T4) days follow-up, following experimental manipulation

Secondary Outcomes (11)

• Salivary cortisol

  Change between T1 and T2: (immediately before and immediately after the manipulation = trauma film paradigm)

• Heart rate

  Change between: immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)

• skin conductance

  Change between: immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)

• Executive function

  Change between T1 and T2: ( immediately before and immediately after the manipulation= trauma film paradigm)

• Quantitative sensory testing- pain psychophysics

  Change between T1 and T2: (immediately before and immediately after the manipulation = trauma film paradigm)

Other Outcomes (7)

• Sensory responsiveness questionnaire (SRQ)

  Baseline ( screening phase)

• The Dissociation Experiences Scale-II (DES-II)

  Baseline ( screening phase)

• Vividness of Visual Imagery Questionnaire (VVIQ)

  Baseline ( screening phase)

Study Arms (2)

traumatic (scenes of injury and death during combat)

EXPERIMENTAL

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.

Behavioral: The Trauma Film Paradigm

non-traumatic (neutral) film

ACTIVE COMPARATOR

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").

Behavioral: non-traumatic (neutral) film

Interventions

non-traumatic (neutral) film BEHAVIORAL

non-traumatic (neutral) film

non-traumatic (neutral) film

The Trauma Film Paradigm 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").

traumatic (scenes of injury and death during combat)

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Intact or corrected vision
• Proficiency in Hebrew

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Dr. Tami Bar-Shalita

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Motion Pictures

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Tami Bar-Shalita, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

• Yael Lahav, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

• Michal Lifshitz, MD

  Israel Defense Forces

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to group allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: August 1, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)