Prevention of Post Traumatic Stress Disorder Following Trauma by Attention Control Training
Condition: PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.

      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.
    

Intervention name(s): Attention Control Training
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PTSD prevention; Acute stress disorder; Attention training; Cognitive bias modification