PTSDNCT06484803
Resilience Among Trauma Survivors
An observational study of PTSD, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
A major gap remains in understanding the neurobehavioral mechanism of individuals' variability in the dynamic process of responding to traumatic events. To address this gap, the proposed study is focused on two dominant survival processes: acute stress response and motivational behavior. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Oct 2021to 30 Sep 2024
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult civilians admitted to Tel-Aviv Sourasky Medical Center's Emergency Room (ER), following a potentially traumatic incident.
Who may be able to join
- Participated in the initial study after an exposure to a traumatic event.
- Age:18 - 70 years.
- Able to read and comprehend Hebrew.
Who cannot join
- Individuals who can't perform an MRI due to safety reasons (e.g. irremovable metals in their body) or claustrophobia.
- Individuals with a diagnosis of substance abuse, psychotic or bipolar I disorder.
- Individuals with documented head trauma with coma exceeding 30 minutes or with known neurological deficit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Search for Neurobehavioral Underpins of Resilience to Stress
A major gap remains in understanding the neurobehavioral mechanism of individuals' variability in the dynamic process of responding to traumatic events. To address this gap, the proposed study is focused on two dominant survival processes: acute stress response and motivational behavior. Investigating the involvement of these processes in long-term recovery from a documented traumatic event, our study extends a prior longitudinal investigation in our lab that systematically assessed the neurobehavioral factors contributing to the development of PTSD.
Read the detailed description
Individual responses to potentially traumatic stress exhibit wide variation, reflecting differences in stress resilience - denoting the capacity to adaptively cope with and recover from adversity (i.e. health despite adversity). To date, growing evidence tracing symptoms' changes following a potentially traumatic event has revealed distinct clinical trajectories, demonstrating variability in the individuals' recovery dynamics following a traumatic event. While some individuals regain homeostasis and recover over time, others experience chronic debilitating dysfunctions and exhibit long-term psychopathology. The current study aims to extend an original longitudinal investigation assessing recent trauma survivors three times within 14 months, with additional clinical and neurobehavioral assessment time points at ~80 months following the exposure to a documented traumatic event. While the previous study focused on assessing neurobehavioral indications of threat and reward sensitivity, this study specifically focused on acute stress response and motivational behavior with respect to trauma recovery trajectory.
Acute stress response involves immediate neurophysiological and psychological reactions to perturbing occurrence, transitioning from a reactive phase to a recovery phase. The reactivity phase is characterized by a threat to physical and mental homeostasis, manifested in multiple neurobiological processes. Subsequently, the stress response transitions to the recovery phase, distinguished by restoring homeostasis and establishing a new memory for coping in the future. The novel dataset collected in this study including fMRI task and resting state, behavioral and biological measurements, enables examination of the neurophysiological mechanism underlying lab-induced acute stress reactivity and recovery and associates it with long-term clinical outcomes following life event adversity. Motivation plays a crucial role in driving the individual's behavior toward a desirable (i.e. rewarding) goal and assists in adaptive coping with the environment. An intriguing finding in the original longitudinal study pointed to the importance of preserved reward processing for resilience. However, the study lacks an exploration of goal-based behavior in motivation which is critical for adaptive coping following stress (e.g. deciding to make an effort and pursue rewarding stimuli despite the possibility of encountering an unpleasant occurrence such as a traumatic reminder). In this project, we posit neurobehavioral aspects of motivational goal-directed behavior (as indicated by approaching or avoiding rewards under risk) will be associated with the long-term dynamics of recovery among trauma survivors. Neuronally, the indicated stress and motivation processes are depicted by functionality patterns in circuits involved in stress and threat (e.g. amygdala, insula, and periaqueductal gray; PAG), motivation (e.g. ventral striatum, orbital-PFC, and Ventral Tegmental Area; VTA) and memory, learning and emotion regulation (e.g. hippocampus and ventromedial-PFC).
In the current study, participants from the initial longitudinal study were recruited for a fourth-time point (~60 months following trauma exposure) and a fifth-time point (~80 months following trauma exposure). The fourth evaluation point involved clinical assessment, fMRI scan, physiological measurements, saliva collection for cortisol, and blood sampling (for epigenetic indices). The fifth time point involved home-based self-report questionnaires to evaluate the impact of the October 7th, 2023 events on the participants' clinical status.
- Conditions
- PTSD
- Keywords
- Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Clinical trajectories
Change in PTSD symptoms measured by change in Clinician-Administered PTSD Scale. The Clinician-Administered PTSD Scale is used to assess PTSD diagnostic status and symptom severity. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5) at 4 time points after exposure (1mo, 6mo, 14mo, ~60mo).
Measured: Approximately 6 years
Change in PTSD symptoms following the October 7th, 2023 events
Measured by the PTSD Checklist (PCL-5), a self-report measure (20 items) assessing the severity of PTSD symptoms, reflecting the diagnostic criteria of DSM-5. The PCL-5 total score can range from 0-80; with higher scores reflecting greater severity.
Measured: Half an hour
Change in anxiety symptoms following the October 7th, 2023 events
Measured by the Beck Anxiety Inventory (BAI), a self-reported measure (21 items) of concurrent anxiety symptoms.
Measured: Half an hour
Change in depressive symptoms following the October 7th, 2023 events
Measured by the Beck Depression Inventory (BDI), a self-reported measure (21 items) of depression symptoms and intensity, which was proven to be a good predictor of chronic PTSD at one week and one month after trauma.
Measured: Half an hour
Secondary outcomes (3)
Neural response to acute stress induction and PTSD resilience
During functional Magnetic Resonance Imaging (fMRI) session, an acute stress induction task known as The Montreal Imaging Stress Task (MIST) is administered. MIST is a psychosocial acute stress induction task incorporating mental arithmetic and social evaluation, tailored to the requirements of the fMRI environment. The task comprises three conditions: rest, training (control), and test (stress).
The outcome will be measured as the changes in the salience network (e.g. amygdala, insula, ACC), default mode network (PCC, hippocampus), and central executive network (e.g. dorsolateral PFC), during acute stress induction vs control condition. These alterations will be correlated with Post-Traumatic Stress Disorder (PTSD) resilience, operationalized by the CAPS score.
Measured: 4 hours
Neural measures of reward and punishment and PTSD resilience
A motivational task (Punishment, Reward, and Incentive Motivation Game; Primo) is conducted during an fMRI session. PRIMO is a dynamic motivational task designed to manipulate motivational aspects within the constraints of the fMRI environment. Neural measures of reward and punishment will be assessed during fMRI scanning. The region of interest (ROI) analysis of the ventral striatum (VS) and ventromedial prefrontal cortex (vmPFC) will be defined. Additionally, other mesolimbic nodes will be delineated based on a meta-analysis of reward-related literature. The outcome will be measured as the association between PTSD resilience, operationalized by the delta between the CAPS scores, and the contrast between reward vs punishment during the PRIMO task.
Measured: 4 hours
Neurobehavioral Measures of Approach-Avoidance Conflict Related to PTSD Resilience
During the fMRI scanning session, neurobehavioral measures of approach-avoidance conflict will be evaluated as participants engage in the PRIMO task (see above). ROI analysis of the VS and ventral tegmental area (VTA) will be defined. Moreover, other mesolimbic nods will be defined based on a meta-analysis of approach-avoidance conflict. The outcome will be measured as the association between PTSD resilience, operationalized by the delta between the CAPS scores, and approach regions under high vs low goal conflict in the game (PRIMO).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 Oct 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484803
- Sponsor's protocol ID
- 0918-20-TLV
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Search for Neurobehavioral Underpins of Resilience to Stress
- ClinicalTrials.gov ID
- NCT06484803
- Acronym / sponsor ID
- 0918-20-TLV
- Conditions
- PTSD
- Keywords
- Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 3 Jul 2024 (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.
A major gap remains in understanding the neurobehavioral mechanism of individuals' variability in the dynamic process of responding to traumatic events. To address this gap, the proposed study is focused on two dominant survival processes: acute stress response and motivational behavior. Investigating the involvement of these processes in long-term recovery from a documented traumatic event, our study extends a prior longitudinal investigation in our lab that systematically assessed the neurobehavioral factors contributing to the development of PTSD.
Detailed description
Individual responses to potentially traumatic stress exhibit wide variation, reflecting differences in stress resilience - denoting the capacity to adaptively cope with and recover from adversity (i.e. health despite adversity). To date, growing evidence tracing symptoms' changes following a potentially traumatic event has revealed distinct clinical trajectories, demonstrating variability in the individuals' recovery dynamics following a traumatic event. While some individuals regain homeostasis and recover over time, others experience chronic debilitating dysfunctions and exhibit long-term psychopathology. The current study aims to extend an original longitudinal investigation assessing recent trauma survivors three times within 14 months, with additional clinical and neurobehavioral assessment time points at ~80 months following the exposure to a documented traumatic event. While the previous study focused on assessing neurobehavioral indications of threat and reward sensitivity, this study specifically focused on acute stress response and motivational behavior with respect to trauma recovery trajectory.
Acute stress response involves immediate neurophysiological and psychological reactions to perturbing occurrence, transitioning from a reactive phase to a recovery phase. The reactivity phase is characterized by a threat to physical and mental homeostasis, manifested in multiple neurobiological processes. Subsequently, the stress response transitions to the recovery phase, distinguished by restoring homeostasis and establishing a new memory for coping in the future. The novel dataset collected in this study including fMRI task and resting state, behavioral and biological measurements, enables examination of the neurophysiological mechanism underlying lab-induced acute stress reactivity and recovery and associates it with long-term clinical outcomes following life event adversity. Motivation plays a crucial role in driving the individual's behavior toward a desirable (i.e. rewarding) goal and assists in adaptive coping with the environment. An intriguing finding in the original longitudinal study pointed to the importance of preserved reward processing for resilience. However, the study lacks an exploration of goal-based behavior in motivation which is critical for adaptive coping following stress (e.g. deciding to make an effort and pursue rewarding stimuli despite the possibility of encountering an unpleasant occurrence such as a traumatic reminder). In this project, we posit neurobehavioral aspects of motivational goal-directed behavior (as indicated by approaching or avoiding rewards under risk) will be associated with the long-term dynamics of recovery among trauma survivors. Neuronally, the indicated stress and motivation processes are depicted by functionality patterns in circuits involved in stress and threat (e.g. amygdala, insula, and periaqueductal gray; PAG), motivation (e.g. ventral striatum, orbital-PFC, and Ventral Tegmental Area; VTA) and memory, learning and emotion regulation (e.g. hippocampus and ventromedial-PFC).
In the current study, participants from the initial longitudinal study were recruited for a fourth-time point (~60 months following trauma exposure) and a fifth-time point (~80 months following trauma exposure). The fourth evaluation point involved clinical assessment, fMRI scan, physiological measurements, saliva collection for cortisol, and blood sampling (for epigenetic indices). The fifth time point involved home-based self-report questionnaires to evaluate the impact of the October 7th, 2023 events on the participants' clinical status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult civilians admitted to Tel-Aviv Sourasky Medical Center's Emergency Room (ER), following a potentially traumatic incident.
Key inclusion criteria (3 listed)
- Participated in the initial study after an exposure to a traumatic event.
- Age:18 - 70 years.
- Able to read and comprehend Hebrew.
Key exclusion criteria (3 listed)
- Individuals who can't perform an MRI due to safety reasons (e.g. irremovable metals in their body) or claustrophobia.
- Individuals with a diagnosis of substance abuse, psychotic or bipolar I disorder.
- Individuals with documented head trauma with coma exceeding 30 minutes or with known neurological deficit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PTSD Clinical trajectories
Time frame: Approximately 6 years
Change in PTSD symptoms measured by change in Clinician-Administered PTSD Scale. The Clinician-Administered PTSD Scale is used to assess PTSD diagnostic status and symptom severity. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5) at 4 time points after exposure (1mo, 6mo, 14mo, ~60mo).
Change in PTSD symptoms following the October 7th, 2023 events
Time frame: Half an hour
Measured by the PTSD Checklist (PCL-5), a self-report measure (20 items) assessing the severity of PTSD symptoms, reflecting the diagnostic criteria of DSM-5. The PCL-5 total score can range from 0-80; with higher scores reflecting greater severity.
Change in anxiety symptoms following the October 7th, 2023 events
Time frame: Half an hour
Measured by the Beck Anxiety Inventory (BAI), a self-reported measure (21 items) of concurrent anxiety symptoms.
Change in depressive symptoms following the October 7th, 2023 events
Time frame: Half an hour
Measured by the Beck Depression Inventory (BDI), a self-reported measure (21 items) of depression symptoms and intensity, which was proven to be a good predictor of chronic PTSD at one week and one month after trauma.
3 secondary outcomes
Neural response to acute stress induction and PTSD resilience
Time frame: 4 hours
Neural measures of reward and punishment and PTSD resilience
Time frame: 4 hours
Neurobehavioral Measures of Approach-Avoidance Conflict Related to PTSD Resilience
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by Tel-Aviv Sourasky Medical Center 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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?
Results are not available in the source record.
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?
PTSD Clinical trajectories (time frame: Approximately 6 years). The study lists 4 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 3 Jul 2024.