IOK Treatment Study



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:October 2012
End Date:January 2015

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A Novel PTSD Treatment for Veterans Who Killed in War

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.

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.

Inclusion Criteria:

- Combat Veterans ranging in age from 18-70 years will be recruited to participate in
this study. Combat veterans ranging in age from 70 to 90 years will also be
considered for enrollment in the study on a case-by-case basis.

- Veterans will need to endorse having taken a life in a war zone context, to meet
criteria for PTSD, and to have received some prior treatment for PTSD to be included
in the study.

- Participants in current PTSD treatment will not be excluded; however, if receiving
medications, they will need to be stabilized on current medications for at least one
month.

- If receiving Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT), the two
treatments the VA recognizes as evidence-based treatment for PTSD, individuals will
need to wait two weeks after they have completed the treatment in order to enroll in
the study, and new baseline measures will be obtained at that time.

Exclusion Criteria:

- Potential participants will only be excluded if they meet current or lifetime
criteria for a psychotic disorder.
We found this trial at
1
site
San Francisco, California 94121
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mi
from
San Francisco, CA
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