PTSDNCT02591485
Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training
A study of PTSD, run by Yair Bar-Haim at 1 site in Israel.
Trial summary
The purpose of this study is to explore the efficacy of Attention Control Training in preventing the development of Post Traumatic Stress Disorder (PTSD), during the period near after a traumatic event and before PTSD is develop. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to Mar 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The occurrence of a traumatic event (criteria A of PTSD from the DSM-5) in the period of less than a month from the beginning of the study.
- An ASD diagnosis (score 7 and above in the ASDI).
Who cannot join
- A previous traumatic event in the period of three month or less before the current event.
- Chronic PTSD.
- A diagnosis of psychotic or bipolar disorders.
- A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
- Suicidal ideation.
- Drugs or alcohol abuse.
Show all 12Show fewer
- Another psychotherapeutic treatment.
- A pharmacological treatment that is not stabilized in the past 6 months (A stable pharmacological treatment will not be a reason for exclusion from the study).
- Poor judgment capacity (i.e., special populations).
- Pregnant women.
- Within Study exclusion criteria:
- Disagreement to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the efficacy of Attention Control Training in preventing the development of Post Traumatic Stress Disorder (PTSD), during the period near after a traumatic event and before PTSD is develop.
Individuals who underwent a traumatic event in the past two weeks will be randomly assigned to either Attention Control Training (ACT), designed to normalize threat-related attention biases or a control conditions: without intervention at all.
Read more
Outcome measures will be a diagnosed of PTSD and the level of severity of symptoms derived from the Clinician Administered PTSD Scale (CAPS-5), after 3 month since the traumatic event had occurred.
The investigators expected to find lower ratios of PTSD symptoms in the ACT condition relative to the control condition in which no symptomatic relief is expected.
Read the detailed description
Background 13-21% out of the people exposed to a potentially traumatic event suffer from Acute Stress Disorder (ASD; American Psychiatric Association, 2013). Findings show that 70% of the people who are diagnosed with ASD during the first month following the traumatic event go on to develop Post-Traumatic Stress Disorder (PTSD; Harvey \& Bryant, 1998). PTSD is characterized by re-experiencing of the traumatic event, avoiding situations that remind the event, hypervigilance, and negative feelings and beliefs about the self.
A neurocognitive mechanism that may become disarrayed in PTSD is the threat monitoring system. This system is responsible for monitoring potential threats and for generating adequate behavioral and emotional responses to an ever-changing environment. Recent studies have shown that this system is impaired in PTSD (Iacoviello, et al., 2014; Naim, et al., 2015) and that Attention Control Training (ACT), which balances the system's activity, is related to improvement in PTSD symptoms (Badura-Brack, et al., 2015). Therefore, the aim of the current study is to explore the efficacy of the ACT in preventing the development of PTSD during the period near after the traumatic event and before PTSD is developed.
To this end, the investigators will recruit participants that arrived at the emergency department at the Tel Aviv Sourasky Medical Center ('Ichilov') and experienced a potentially traumatic event (according to the criteria of the Diagnostic and Statistical Manual of mental disorders (the DSM-V). Potential participants will be explained about the study and be asked to provide informed consent to participate. Those who agree to participate will be contacted via a telephone call 10-14 days after the event, and a diagnostic interview will be conducted to determine the presence of ASD, and to determine whether the potential participants meet the inclusion criteria for the study. Those who will exhibit a high level of ASD symptoms will be included in the study.
Those included will be randomly assigned to one of two conditions detailed below. the investigators expected to recruit 4000 candidates at the emergency room, with the expectation that 10% of them (~600 participants) will have ASD 10-14 days later.
Procedure The participants will be individuals who were recently exposed to a potentially traumatic event and arrived at the emergency department in the Tel Aviv Sourasky Medical Center (Ichilov). The study procedure and its aims will be explained to the candidates and they will have to provide written informed consent to be included. The recruitment will be conducted by the research team that will be trained for that purpose and will stay in shifts in the emergency department in coordination with the medical team.
Ten to fourteen days after the event, the participants who agreed to participate and signed the informed consent will be contacted by telephone. In this conversation, a diagnostic interview for ASD (Acute Stress Disorder Interview, ASDI; Bryant, Harvey, Dang, \& Sackville, 1998) will be conducted in addition to questions about potential exclusion criteria. Those who demonstrate a high level of ASD symptoms (scores 7 and above in the ASDI), will be randomly assigned to one of two conditions: attention control training (ACT) intervention, or a control condition without intervention.
In the ACT intervention, participants will perform six computerized attention training sessions, 10 minutes per training session over six weeks (a session once a week). Training will be done through a username and password protected website designated for this purpose, so the participants could complete the training from home. In addition, the participants assigned to the control condition without intervention will be followed-up three months after recruitment.
At the end of the intervention period, a clinical interview will be conducted through telephone where a PTSD diagnosis (CAPS-5 interview; Weathers, Blake, Schnurr, Kaloupek, Marx, \& Keane ,2013) and other clinical symptoms will be assessed. The interview will be delivered by graduate-level clinical psychology students trained by a senior clinical psychologist. Participants from the control intervention group who will have PTSD in the diagnostic point will be offered to participate in the condition that has shown the most effective improvement.
The duration of the study procedure for each participant will be three months.
- Conditions
- PTSD
- Being tested
- Attention Control Training
- Keywords
- PTSD prevention, Acute stress disorder, Attention training, Cognitive bias modification
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Control TrainingBehavioural
In the ACT, participants perform six computerized attention training sessions, 10 minutes per training session over six weeks. In each session the dot-probe task is administered. This task is consisted of 160 trials. Each trial began with a centrally-presented fixation cross that then replaced by a pair of words presented. Following that, a target probe appeared in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. Targets appear with equal probability at the location of threat and neutral stimuli, in order to modify the fluctuations in attention allocation.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control Training | Experimental | Computerized attention modification training, comprised of six sessions that delivered by internet, in purpose of modulate biases in attention for threat stimuli. Receives: Behavioral: Attention Control Training |
| Follow-up only | No intervention | In this condition, a follow-up interviews will be conducted 3 months since the traumatic event had occurred. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview.
The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated (Weathers, Blake, Schnurr, Kaloupek, Marx, \& Keane, 2013).
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yair Bar-Haim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, Prof., Study director, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591485
- Sponsor's protocol ID
- TASMC - 15 - PH - 0409 - CTIL
- Status last verified
- Nov 2019
- First submitted
- 28 Oct 2015
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Weathers, F., Blake, D., Schnurr, P., Kaloupek, D., Marx, B., & Keane, T., The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov, 2013.
Weathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx, & P. Schnurr, The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 2013.
American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 2013: American Psychiatric Pub.
Harvey AG, Bryant RA. The relationship between acute stress disorder and posttraumatic stress disorder: a prospective evaluation of motor vehicle accident survivors. J Consult Clin Psychol. 1998 Jun;66(3):507-12. doi: 10.1037//0022-006x.66.3.507.
PubMed 9642889Iacoviello BM, Wu G, Abend R, Murrough JW, Feder A, Fruchter E, Levinstein Y, Wald I, Bailey CR, Pine DS, Neumeister A, Bar-Haim Y, Charney DS. Attention bias variability and symptoms of posttraumatic stress disorder. J Trauma Stress. 2014 Apr;27(2):232-239. doi: 10.1002/jts.21899. Epub 2014 Mar 6.
PubMed 24604631Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
PubMed 26206075Naim R, Abend R, Wald I, Eldar S, Levi O, Fruchter E, Ginat K, Halpern P, Sipos ML, Adler AB, Bliese PD, Quartana PJ, Pine DS, Bar-Haim Y. Threat-Related Attention Bias Variability and Posttraumatic Stress. Am J Psychiatry. 2015 Dec;172(12):1242-50. doi: 10.1176/appi.ajp.2015.14121579. Epub 2015 Jul 24.
PubMed 26206076Bryant, R. A., Harvey, A., G., Dang, S., T., & Sackville, T., Assessing acute stress disorder: Psychometric properties of a structured clinical interview. Psychological Assessment, 1998. 10(3): p. 215.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training
- ClinicalTrials.gov ID
- NCT02591485
- Acronym / sponsor ID
- TASMC - 15 - PH - 0409 - CTIL
- Conditions
- PTSD
- Keywords
- PTSD prevention, Acute stress disorder, Attention training, Cognitive bias modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Yair Bar-HaimUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 29 Oct 2015 (estimated)
- 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.
The purpose of this study is to explore the efficacy of Attention Control Training in preventing the development of Post Traumatic Stress Disorder (PTSD), during the period near after a traumatic event and before PTSD is develop.
Individuals who underwent a traumatic event in the past two weeks will be randomly assigned to either Attention Control Training (ACT), designed to normalize threat-related attention biases or a control conditions: without intervention at all.
Outcome measures will be a diagnosed of PTSD and the level of severity of symptoms derived from the Clinician Administered PTSD Scale (CAPS-5), after 3 month since the traumatic event had occurred.
The investigators expected to find lower ratios of PTSD symptoms in the ACT condition relative to the control condition in which no symptomatic relief is expected.
Detailed description
Background 13-21% out of the people exposed to a potentially traumatic event suffer from Acute Stress Disorder (ASD; American Psychiatric Association, 2013). Findings show that 70% of the people who are diagnosed with ASD during the first month following the traumatic event go on to develop Post-Traumatic Stress Disorder (PTSD; Harvey \& Bryant, 1998). PTSD is characterized by re-experiencing of the traumatic event, avoiding situations that remind the event, hypervigilance, and negative feelings and beliefs about the self.
A neurocognitive mechanism that may become disarrayed in PTSD is the threat monitoring system. This system is responsible for monitoring potential threats and for generating adequate behavioral and emotional responses to an ever-changing environment. Recent studies have shown that this system is impaired in PTSD (Iacoviello, et al., 2014; Naim, et al., 2015) and that Attention Control Training (ACT), which balances the system's activity, is related to improvement in PTSD symptoms (Badura-Brack, et al., 2015). Therefore, the aim of the current study is to explore the efficacy of the ACT in preventing the development of PTSD during the period near after the traumatic event and before PTSD is developed.
To this end, the investigators will recruit participants that arrived at the emergency department at the Tel Aviv Sourasky Medical Center ('Ichilov') and experienced a potentially traumatic event (according to the criteria of the Diagnostic and Statistical Manual of mental disorders (the DSM-V). Potential participants will be explained about the study and be asked to provide informed consent to participate. Those who agree to participate will be contacted via a telephone call 10-14 days after the event, and a diagnostic interview will be conducted to determine the presence of ASD, and to determine whether the potential participants meet the inclusion criteria for the study. Those who will exhibit a high level of ASD symptoms will be included in the study.
Those included will be randomly assigned to one of two conditions detailed below. the investigators expected to recruit 4000 candidates at the emergency room, with the expectation that 10% of them (~600 participants) will have ASD 10-14 days later.
Procedure The participants will be individuals who were recently exposed to a potentially traumatic event and arrived at the emergency department in the Tel Aviv Sourasky Medical Center (Ichilov). The study procedure and its aims will be explained to the candidates and they will have to provide written informed consent to be included. The recruitment will be conducted by the research team that will be trained for that purpose and will stay in shifts in the emergency department in coordination with the medical team.
Ten to fourteen days after the event, the participants who agreed to participate and signed the informed consent will be contacted by telephone. In this conversation, a diagnostic interview for ASD (Acute Stress Disorder Interview, ASDI; Bryant, Harvey, Dang, \& Sackville, 1998) will be conducted in addition to questions about potential exclusion criteria. Those who demonstrate a high level of ASD symptoms (scores 7 and above in the ASDI), will be randomly assigned to one of two conditions: attention control training (ACT) intervention, or a control condition without intervention.
In the ACT intervention, participants will perform six computerized attention training sessions, 10 minutes per training session over six weeks (a session once a week). Training will be done through a username and password protected website designated for this purpose, so the participants could complete the training from home. In addition, the participants assigned to the control condition without intervention will be followed-up three months after recruitment.
At the end of the intervention period, a clinical interview will be conducted through telephone where a PTSD diagnosis (CAPS-5 interview; Weathers, Blake, Schnurr, Kaloupek, Marx, \& Keane ,2013) and other clinical symptoms will be assessed. The interview will be delivered by graduate-level clinical psychology students trained by a senior clinical psychologist. Participants from the control intervention group who will have PTSD in the diagnostic point will be offered to participate in the condition that has shown the most effective improvement.
The duration of the study procedure for each participant will be three months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control Training | Experimental | Behavioral: Attention Control TrainingComputerized attention modification training, comprised of six sessions that delivered by internet, in purpose of modulate biases in attention for threat stimuli. |
| Follow-up only | No intervention | –In this condition, a follow-up interviews will be conducted 3 months since the traumatic event had occurred. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The occurrence of a traumatic event (criteria A of PTSD from the DSM-5) in the period of less than a month from the beginning of the study.
- An ASD diagnosis (score 7 and above in the ASDI).
Key exclusion criteria (12 listed)
- A previous traumatic event in the period of three month or less before the current event.
- Chronic PTSD.
- A diagnosis of psychotic or bipolar disorders.
- A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
- Suicidal ideation.
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 |
|---|---|---|
| Attention Control TrainingIn the ACT, participants perform six computerized attention training sessions, 10 minutes per training session over six weeks. In each session the dot-probe task is administered. This task is consisted of 160 trials. Each trial began with a centrally-presented fixation cross that then replaced by a pair of words presented. Following that, a target probe appeared in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. Targets appear with equal probability at the location of threat and neutral stimuli, in order to modify the fluctuations in attention allocation. | Behavioural | Attention Control Training |
Primary outcome
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview.
Time frame: 40 minutes
The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated (Weathers, Blake, Schnurr, Kaloupek, Marx, \& Keane, 2013).
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 25 Nov 2019.
- BackgroundWeathers, F., Blake, D., Schnurr, P., Kaloupek, D., Marx, B., & Keane, T., The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov, 2013.
- BackgroundWeathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx, & P. Schnurr, The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 2013.
- BackgroundAmerican Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 2013: American Psychiatric Pub.
- Background: PubMed 9642889Harvey AG, Bryant RA. The relationship between acute stress disorder and posttraumatic stress disorder: a prospective evaluation of motor vehicle accident survivors. J Consult Clin Psychol. 1998 Jun;66(3):507-12. doi: 10.1037//0022-006x.66.3.507.
- Background: PubMed 24604631Iacoviello BM, Wu G, Abend R, Murrough JW, Feder A, Fruchter E, Levinstein Y, Wald I, Bailey CR, Pine DS, Neumeister A, Bar-Haim Y, Charney DS. Attention bias variability and symptoms of posttraumatic stress disorder. J Trauma Stress. 2014 Apr;27(2):232-239. doi: 10.1002/jts.21899. Epub 2014 Mar 6.
- Background: PubMed 26206075Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
- Background: PubMed 26206076Naim R, Abend R, Wald I, Eldar S, Levi O, Fruchter E, Ginat K, Halpern P, Sipos ML, Adler AB, Bliese PD, Quartana PJ, Pine DS, Bar-Haim Y. Threat-Related Attention Bias Variability and Posttraumatic Stress. Am J Psychiatry. 2015 Dec;172(12):1242-50. doi: 10.1176/appi.ajp.2015.14121579. Epub 2015 Jul 24.
- BackgroundBryant, R. A., Harvey, A., G., Dang, S., T., & Sackville, T., Assessing acute stress disorder: Psychometric properties of a structured clinical interview. Psychological Assessment, 1998. 10(3): p. 215.
- Individual participant dataSharing planned: No
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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.
Yair Bar-Haim, Prof. study director
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of PTSD, run by Yair Bar-Haim 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 12 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 25 Nov 2019. 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?
A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview. (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591485, which also lists 8 linked publications.
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 25 Nov 2019.