Clinical trial NCT05967962: Sensory Modulation Dysfunction and Posttraumatic Stress Disorder
Official title: Sensory Modulation Dysfunction as a Risk Factor for Posttraumatic Stress Disorder - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sensory Processing Disorder
Keywords: sensory processing
executive function
trauma
peritrauma
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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)

Primary outcomes:
measure: Pain Sensitivity Questionnaire (PSQ)
timeFrame: Change from immediately before and immediately after the manipulation and 40 days post undertaking the manipulation
measure: Spontaneously occurring memories
timeFrame: 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:
measure: Salivary cortisol
timeFrame: Change between T1 and T2: (immediately before and immediately after the manipulation = trauma film paradigm)
measure: Heart rate
timeFrame: Change between: immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
measure: skin conductance
timeFrame: Change between: immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
measure: Executive function
timeFrame: Change between T1 and T2: ( immediately before and immediately after the manipulation= trauma film paradigm)
measure: Quantitative sensory testing- pain psychophysics
timeFrame: Change between T1 and T2: (immediately before and immediately after the manipulation = trauma film paradigm)
measure: Face reading
timeFrame: Change between immediately before (T1) and immediately after the manipulation = trauma film paradigm (T2)
measure: The State- Trait anxiety Inventory (STAI)
timeFrame: Change between T1 and T2: (immediately before and immediately after the manipulation= trauma film paradigm)
measure: Dissociation-Tension-Scale
timeFrame: T2: (immediately after the manipulation= trauma film paradigm)
measure: Distress after trauma film paradigm
timeFrame: T2: (immediately after the manipulation= trauma film paradigm)
measure: The Impact of Event Scale-Revised (IES-R)
timeFrame: Change between T3 and T4: (10 and 40 days post undertaking the manipulation =trauma film paradigm)
measure: Skin conductance
timeFrame: Change between: immediately before (T1) and immediately after (T2) the manipulation = trauma film paradigm)
Other outcomes:
measure: Sensory responsiveness questionnaire (SRQ)
timeFrame: Baseline ( screening phase)
measure: The Dissociation Experiences Scale-II (DES-II)
timeFrame: Baseline ( screening phase)
measure: Vividness of Visual Imagery Questionnaire (VVIQ)
timeFrame: Baseline ( screening phase)
measure: Life Events Checklist for DSM-5 (LEC-5)
timeFrame: Baseline ( screening phase)
measure: Post Traumatic Groth Inventory (PTGI)
timeFrame: Baseline ( screening phase)
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline ( screening phase)
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline ( screening phase)
Locations:
city: Tel Aviv
country: Israel
facility: Dr. Tami Bar-Shalita
Study officials:
affiliation: Tel Aviv University
name: Tami Bar-Shalita, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv University
name: Yael Lahav, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Israel Defense Forces
name: Michal Lifshitz, MD
role: PRINCIPAL_INVESTIGATOR
References: