Posttraumatic Stress DisorderNCT05967962
Sensory Modulation Dysfunction and Posttraumatic Stress Disorder
A study testing The Trauma Film Paradigm and non-traumatic (neutral) film in people with Posttraumatic Stress Disorder and Sensory Processing Disorder, run by Tel Aviv University at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Sensory Processing Disorder
- What is being tested?
- The Trauma Film Paradigm and non-traumatic (neutral) film
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Intact or corrected vision
- Proficiency in Hebrew
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Sensory Modulation Dysfunction as a Risk Factor for Posttraumatic Stress Disorder - A Randomized Control Trial
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.
Read the 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.
- Being tested
- The Trauma Film Paradigm, non-traumatic (neutral) film
- Keywords
- sensory processing, executive function, trauma, peritrauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Trauma Film ParadigmBehavioural
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) filmBehavioural
non-traumatic (neutral) film
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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"). Receives: Behavioral: non-traumatic (neutral) film |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Using commercially available cortisol electrochemiluminescent immunoassays (ECLIA) kits (Roche Diagnostics GmbH, Mannheim, Germany) on a cobas e801 module (Roche Diagnostics GmbH)
Measured: Change between T1 and T2: (immediately before and immediately after the manipulation = trauma film paradigm)
Heart rate
Recorded via the Mindware BioNex 8-slot chassis acquisition system (Mindware Technologies Ltd, Gahanna,OH, USA
Measured: Change between: immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
skin conductance
Recorded via the Mindware BioNex 8-slot chassis acquisition system (Mindware Technologies Ltd, Gahanna,OH, USA
Measured: Change between: immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
Executive function
The executive function will be measured using 2 performance-based tests, both testing the same outcomes, to avoid the learning effect which may occur when using one in short intervals: (i) Trail making test (TMT) (at pre-experimental manipulation) and (ii). Color trail test (CTT) (at post-experimental manipulation), alternating between subjects. Both tests are widely used to assess executive function and specifically target visual scanning, processing speed, and capacity to maintain focus attention/mental flexibility, providing 2 scores: speed of completion and error rate.
Measured: Change between T1 and T2: ( immediately before and immediately after the manipulation= trauma film paradigm)
Quantitative sensory testing- pain psychophysics
Thermal and pain thresholds using the Thermal Sensory Analyzer (TSA) (Medoc, Israel). The tests will include cold detection threshold (CDT), warm detection threshold (WDT), cold pain threshold CPT) and warm pain threshold (CPT). The TSA thermod's active area is 32 cm and temperature range is 0°C to a safety limit of 50°C. Each test will be performed three times in the dorsal aspects of the dominant hand. Conditioned pain modulation (CPM) will be tested utilizing heat test stimuli individually tailored rated as 50/100, delivered via the TSA thermod to the volar aspect of the dominant hand, conditioned by the contralateral hand immersed in painfully cold water (7C).
Measured: Change between T1 and T2: (immediately before and immediately after the manipulation = trauma film paradigm)
Face reading
Utilizing the FaceReader hardware (incl.: Webcam, LED ring) and the FaceReader software Base module, during the trauma film paradigm manipulation, all participants will be videotaped using the webcam on their computer screen. The videotapes will be analyzed offline using the FaceReader software Base module to classify emotional reactions
Measured: Change between immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
The State- Trait anxiety Inventory (STAI)
A self-report 2 part questionnaire, assessing both anxiety state and anxiety trait, comprising 20 items each. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. In this study, only the Anxiety state part will be utilized
Measured: Change between T1 and T2: (immediately before and immediately after the manipulation= trauma film paradigm)
Dissociation-Tension-Scale
A 21-item self-report questionnaire designed to assess psychological and somatoform dissociative features. Ratings are made on a 10-point scale ranging from 0 (not at all) to 9 (very much).
Measured: T2: (immediately after the manipulation= trauma film paradigm)
Distress after trauma film paradigm
Three questions self-report aiming at rating participant experience due to the movie scene: 2 with a response scale of 1 ("not distressed") to 10 ("extremely distressed"), and one with a response scale of 1 ( very pleasant) to 5 (very unpleasant), constructed for the purpose of this current study
Measured: T2: (immediately after the manipulation= trauma film paradigm)
The Impact of Event Scale-Revised (IES-R)
Self-report questionnaire for testing Trauma-related symptomatology. The IES-R comprises 22 items that measure symptoms of intrusion (dreams about the event), avoidance and numbing (the effort to avoid reminders of the event), and hyperarousal (feeling watchful and on guard) with respect to a potentially traumatic event. Participants are asked to rate on a 5-point Likert scale the extent to which each item applies to their experiences. The total score on the IES-R ranges between 0 and 88.
Measured: Change between T3 and T4: (10 and 40 days post undertaking the manipulation =trauma film paradigm)
Skin conductance
Recorded via the Mindware BioNex 8-slot chassis acquisition system (Mindware Technologies Ltd, Gahanna,OH, USA
Measured: Change between: immediately before (T1) and immediately after (T2) the manipulation = trauma film paradigm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 May 2023
- Primary completion31 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tami Bar-Shalita, Tel Aviv University
- Investigators
- Tami Bar-Shalita, PhD, Principal investigator, Tel Aviv UniversityYael Lahav, PhD, Principal investigator, Tel Aviv UniversityMichal Lifshitz, MD, Principal investigator, Israel Defense Forces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967962
- Sponsor's protocol ID
- 0005364-2
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Modulation Dysfunction as a Risk Factor for Posttraumatic Stress Disorder - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05967962
- Acronym / sponsor ID
- 0005364-2
- Keywords
- sensory processing, executive function, trauma, peritrauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| traumatic (scenes of injury and death during combat) | Experimental | Behavioral: The Trauma Film ParadigmIn 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. |
| non-traumatic (neutral) film | Active comparator | Behavioral: non-traumatic (neutral) filmIn this active control group, participants will be watching 16 min. non-traumatic, neutral scene showing combatants as well (scenes from the YouTube series "Warriors"). |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Intact or corrected vision
- Proficiency in Hebrew
Key exclusion criteria (7 listed)
- Neurological disorders
- Psychiatric disorders
- Neurodevelopmental disorders
- Substance use disorder
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Trauma Film ParadigmTrauma 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"). | Behavioural | traumatic (scenes of injury and death during combat) |
| non-traumatic (neutral) filmnon-traumatic (neutral) film | Behavioural | non-traumatic (neutral) film |
Primary outcome
Pain Sensitivity Questionnaire (PSQ)
Time frame: Change from immediately before and immediately after the manipulation and 40 days post undertaking the manipulation
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.
Spontaneously occurring memories
Time frame: 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
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
11 secondary outcomes
Salivary cortisol
Time frame: Change between T1 and T2: (immediately before and immediately after the manipulation = trauma film paradigm)
Heart rate
Time frame: Change between: immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
skin conductance
Time frame: Change between: immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
Executive function
Time frame: Change between T1 and T2: ( immediately before and immediately after the manipulation= trauma film paradigm)
Quantitative sensory testing- pain psychophysics
Time frame: Change between T1 and T2: (immediately before and immediately after the manipulation = trauma film paradigm)
Face reading
Time frame: Change between immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
The State- Trait anxiety Inventory (STAI)
Time frame: Change between T1 and T2: (immediately before and immediately after the manipulation= trauma film paradigm)
Dissociation-Tension-Scale
Time frame: T2: (immediately after the manipulation= trauma film paradigm)
Distress after trauma film paradigm
Time frame: T2: (immediately after the manipulation= trauma film paradigm)
The Impact of Event Scale-Revised (IES-R)
Time frame: Change between T3 and T4: (10 and 40 days post undertaking the manipulation =trauma film paradigm)
Skin conductance
Time frame: Change between: immediately before (T1) and immediately after (T2) the manipulation = trauma film paradigm)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. Will be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tami Bar-Shalita, PhD principal investigator
Tel Aviv University
Yael Lahav, PhD principal investigator
Tel Aviv University
Michal Lifshitz, MD principal investigator
Israel Defense Forces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Trauma Film Paradigm and non-traumatic (neutral) film in people with Posttraumatic Stress Disorder and Sensory Processing Disorder, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Sensitivity Questionnaire (PSQ) (time frame: Change from immediately before and immediately after the manipulation and 40 days post undertaking the manipulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.