IOK Treatment Study
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The goals of this project are

        -  1) to evaluate the effectiveness of a CBT treatment module addressing the mental health
           and functional impact of killing in the war zone,

        -  2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility
           of the CBT treatment module, which would be used to further refine the intervention, and

        -  3) to gather data on clinician stakeholders' perceptions of acceptability and
           feasibility of the CBT treatment module, which would be used to ensure that the module
           could be easily integrated into EBT for PTSD.
    

Detailed description: 
      Background: There is mounting evidence that Veterans from multiple eras who kill in war are
      at increased risk for posttraumatic stress disorder (PTSD), alcohol abuse, suicide, and
      functional difficulties after returning home. Despite high rates of exposure to killing and
      associated maladaptive responses, the military and VA do not routinely assess exposure to
      killing, which could assist with prevention and treatment efforts. Furthermore, the impact of
      killing is not currently addressed as a component of evidence-based treatment (EBT) for PTSD.
      In fact, in the current system, a Veteran can receive PTSD evaluation and evidence-based
      treatment without ever being asked about killing and its impact. Some researchers have
      cautioned against using one type of PTSD treatment, one commonly used in the VA, suggesting
      that it may be harmful for these patients. Consequently, it is possible that failing to
      directly treat the mental health impact of killing could result in inappropriate treatment,
      cause harm to Veterans, and cost lives.

      Objectives: Our first aim is to evaluate the effectiveness of a CBT treatment module
      addressing the mental health and functional impact of killing in the war zone, which would be
      added onto existing EBT for PTSD. Our second aim is to gather data on Veteran stakeholders'
      perceptions of acceptability and feasibility of the CBT treatment module, which would be used
      to further refine the intervention. Our third aim is to gather data on clinician
      stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which
      would be used to ensure that the module could be easily integrated into EBT for PTSD.

      Methods: The investigators propose a 12-month pilot, cross-sectional Hybrid Type 2 study,
      given that The investigators will be adding a treatment module to existing EBT for PTSD. The
      investigators will conduct a randomized, controlled effectiveness trial to better understand
      if the six-week treatment module addressing the impact of killing has added benefit, compared
      to PTSD treatment as usual (N = 50). The investigators will employ a concurrent design mixed
      method study to test the perceptions of Veteran stakeholders who receive the treatment
      module, obtaining ratings of acceptability and feasibility through self-report measures and
      interviews. The investigators also will interview clinicians who provide EBT for PTSD, and
      interviews will be guided by Roger's five intrinsic characteristics, as outlined in his
      Diffusion of Innovations Theory.

      Impact: Through involving Veteran and clinician stakeholders, the main impact of this project
      will be to obtain information that will assist in revising the CBT treatment module and help
      prepare for implementing the module in already existing settings, where EBT for PTSD is
      provided.
    

Intervention name(s): IOK Killing Treatment; Wait list control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.; Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Mental Health; War; Veterans