Biological Markers for Post-Traumatic Stress Disorder

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 20 to 60 years
• Men only
• Healthy volunteers accepted
• Adult

Study population: Male combatants aged 20-60 years, with a history of exposure to an apparently life threatening-combat event, with or without PTSD.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Post Traumatic Stress Disorder

Being tested

CAPS questionnaire, Beck Depression Inventory, The Fibromyalgia Impact Questionnaire, The Pittsburgh Sleep Quality Index, Depression, Anxiety and Stress Scale-21 items

Medical subject headings

Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• CAPS questionnaireDiagnostic test

  PTSD diagnosis and severity will be done using the CAPS-5 questionnaire.

• Beck Depression InventoryDiagnostic test

  depression symptoms will be measured by the BDI-II. The BDI-II consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression.

• The Fibromyalgia Impact QuestionnaireDiagnostic test

  The FIQ was developed from information gathered from patient reports, functional status instruments and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue and well-being over the past week.

• The Pittsburgh Sleep Quality IndexDiagnostic test

  sleep patterns will be measured using the PSQI. This index assesses the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, the use of sleeping medications and daytime dysfunction over the last month. Items are rated using a 0 to 3 scale. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

• Depression, Anxiety and Stress Scale-21 itemsDiagnostic test

  The DASS-21 is a three-scale self-report questionnaire designed to measure the emotional state of depression, anxiety and stress. Each scale contains 7 items, divided into subscales with similar content. Scores range between 0 and 21 in each subcategory.

• Traumatic Events QuestionnaireDiagnostic test

  The TEQ examines experiences of traumatic events (e.g. sexual abuse, accidents and crime) that are considered potential triggers of PTSD symptoms. To assess trauma intensity, respondents provide information for each event that was experienced, as well as their age at the time of the event. The items are measured on a 9-point Likert scale from "not at all" to "severely/extremely". The TEQ has previously been used in Israel.

• Clinician Administered Dissociative States ScaleDiagnostic test

  The CADSS is a 28-item structured clinical interview to assess state dissociation.

• A diary will be used for seven consecutive nightsDiagnostic test

  A diary will be used for seven consecutive nights for the evaluation of:

  • Mean sleep latency
  • The number and duration of awakenings.
  • Subjective total sleep time
  • Subjective wake after sleep onset
  • Sleep efficiency

• MRIDiagnostic test

  Brain imaging will include DTI and resting state for structural and functional MRI scanning. Images will be acquired on MAGNETOM Vida 3T Scanner, configured with 64-channel receiver head coils (Siemens Healthcare, Erlangen, Germany) at the Department of Radiology at Shamir Medical Center.

• Functional brain imagingDiagnostic test

  Functional magnetic resonance imaging (fMRI) is widely used to study the operational organization of the human brain. This technology measures brain activity by detecting changes associated with blood oxygenation, using blood-oxygen-level-dependent imaging (BOLD) contrast.

• EEG analysisDiagnostic test

  EEG will be obtained using a point-of care device that consists of an EEG-Sense Headset, EEG-Sense Single-Use brush sensors, a pneumatic sensor positioning mechanism, EEG sampling electronics and software. The EEG-Sense Headset is an EEG electrode positioning system that quickly places electrodes in a uniform and consistent manner, to transfer electrophysiological EEG signals from an individual to a suitable EEG data collection device. The device is nonsterile, non-invasive and non-radiation emitting, and was developed for use in healthcare facilities and hospitals. Typical set-up and procedure time is several minutes. The device does not contain biologics, drugs, coatings or any claim of sterility. The EEG-Sense Single-Use brush sensors are made from well-established medical-grade materials; the Headset is made from Nylon 101. Electronic components and harnesses are embedded between two layers of nylon and are attached to each electrode port.

• Autonomic nervous system monitorsDiagnostic test

  Data will be collected using Empatica's E4 wristband. Each of the study participants will wear the wristband for 7 days.

  Data collected from the band will include:

  ACC - Data from 3-axis accelerometer sensor in the range [-2g, 2g]. (sampled at 32 Hz) BVP - Data from photoplethysmography (PPG). (sampled at 64 Hz) EDA - Data from the electrodermal activity sensor in μS. (sampled at 4 Hz) IBI - Inter-beat intervals. (intermittent output with 1/64 second resolution) TEMP - Data from temperature sensors, expressed in degrees on the Celsius (°C) scale. (sampled at 4 Hz)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. correlation between CAPS score and mean heart rate variability

   the correlation between CAPS score and mean heart rate variability will be evaluated

   Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Jan 2022
2. Study start1 Jan 2022
3. Primary completion1 Dec 2025 (estimated)
4. Study completion1 Jan 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Post Traumatic 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.