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IOK Treatment Study

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ClinicalTrials.gov Identifier: NCT01605799
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : December 17, 2015
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):

May 18, 2012
May 25, 2012
November 13, 2015
December 17, 2015
February 23, 2016
October 2012
January 2015   (Final data collection date for primary outcome measure)
Change in PTSD Symptoms as Measured by the PCL [ Time Frame: PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7) ]
The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV. Possible scores range from 17 (better outcome) to 85 (worse outcome).
PTSD symptoms as measured by the PCL [ Time Frame: PTSD symptoms will be assessed at Baseline (Week 1) ]
The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV.
Complete list of historical versions of study NCT01605799 on ClinicalTrials.gov Archive Site
Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53) [ Time Frame: The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7) ]
The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., "your feelings being easily hurt") on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past seven days. The total score is the sum of all responses [minimum = 0 (better outcome), maximum = 212 (worse outcome)].
  • Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53) [ Time Frame: The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7) ]
    The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism), and three global indices [Global Severity Index (GSI), Positive Symptom Distress Index (PSDI), and Positive Symptom Total (PST)]
  • Killing Cognitions Scale (KCS) [ Time Frame: The KCS will be administered at Baseline or the first study visit and the end of treatment (Week 7). ]
    The KCS is a self report measure of killing-related maladaptive cognitions.
  • Change in PTSD symptoms as measured by the PCL [ Time Frame: Change in PTSD symptoms will be assessed at the end of treatment (Week 7) ]
    The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV.
  • Change in psychological symptoms as measured by the Brief Symptom Inventory (BSI-53) [ Time Frame: Change in BSI will be administered at the end of treatment (Week 7) ]
    The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism), and three global indices [Global Severity Index (GSI), Positive Symptom Distress Index (PSDI), and Positive Symptom Total (PST)]
  • Change in killing related maladaptive cognitions as measured by the Killing Cognitions Scale (KCS) [ Time Frame: Change in KCS will be administered at the end of treatment (Week 7) ]
    The KCS is a self report measure of killing-related maladaptive cognitions.
Not Provided
Not Provided
 
IOK Treatment Study
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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
  • Behavioral: IOK Killing Treatment
    The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
  • Behavioral: Wait list control group
    Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
  • Active Comparator: IOK Treatment
    Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
    Intervention: Behavioral: IOK Killing Treatment
  • Placebo Comparator: Wait list control group
    Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
    Interventions:
    • Behavioral: IOK Killing Treatment
    • Behavioral: Wait list control group
Maguen S, Burkman K. Combat-Related Killing: Expanding Evidence-Based Treatments for PTSD. Cognitive and behavioral practice. 2013 Nov 1; 20(4):476-479.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
January 2015
January 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01605799
RRP 12-237
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Shira Maguen, PhD San Francisco VA Medical Center, San Francisco, CA
VA Office of Research and Development
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP