Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yair Bar-Haim
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview.
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
Attention Control Training
Computerized attention modification training, comprised of six sessions that delivered by internet, in purpose of modulate biases in attention for threat stimuli.
Intervention: Attention Control Training (Behavioral)
Follow-up only
In this condition, a follow-up interviews will be conducted 3 months since the traumatic event had occurred.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Yair Bar-Haim
Professor Yair Bar-Haim
Tel Aviv University
