Ignite Creation Date:
2024-05-06 @ 7:44 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02591485
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2015-10-28
Brief Title:
Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training
Sponsor:
Yair Bar-Haim
Organization:
Tel Aviv University
Study Overview
Official Title:
Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 systems 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
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 systems 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None