IOK Treatment Study

January 22, 2016 updated by: VA Office of Research and Development

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center, San Francisco, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 will be assessed at Baseline or the first study visit and the end of treatment (Week 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)].
The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Maguen S, Burkman K. Combat-Related Killing: Expanding Evidence-Based Treatments for PTSD. Cognitive and behavioral practice. 2013 Nov 1; 20(4):476-479.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 18, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRP 12-237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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