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IOK Treatment Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01605799
First received: May 18, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention Phase
Posttraumatic Stress Disorder
Behavioral: IOK Killing Treatment
Behavioral: Wait list control group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Novel PTSD Treatment for Veterans Who Killed in War

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    The KCS is a self report measure of killing-related maladaptive cognitions.


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IOK Treatment
Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605799

Locations
United States, California
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
Sponsors and Collaborators
Investigators
Principal Investigator: Shira Maguen, PhD VA Medical Center, San Francisco
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01605799     History of Changes
Other Study ID Numbers: RRP 12-237
Study First Received: May 18, 2012
Last Updated: July 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PTSD
Mental Health
War
Veterans

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 23, 2014