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Treatment for the Mental Health Impact of Killing in War

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01406834
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : August 18, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The goal of this project is to test the feasibility, acceptability, and efficacy of a treatment module addressing the mental health and functional impact of killing in the war zone.

The investigators will enroll between 12-20 Veterans who have killed in war and have been diagnosed with post-traumatic stress disorder (PTSD) for a pilot study assessing the efficacy of the six-session treatment. Veterans will be randomized either to the treatment or to the waitlist control group.


Condition or disease Intervention/treatment
Posttraumatic Stress Disorder (PTSD) Behavioral: Impact of Killing CBT Treatment

Study Design

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Treatment for the Mental Health Impact of Killing in War: Augmentation of Existing Evidence-Based Mental Health Interventions
Study Start Date : October 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Behavioral: Impact of Killing CBT Treatment
    Treatment will include six, one hours sessions with a licensed clinical psychologist or an advanced postdoctoral fellow under the close supervision of a licensed psychologist.

Outcome Measures

Primary Outcome Measures :
  1. Change in psychological symptoms as measured by the Symptom Checklist-90 (SCL-90-R) [ Time Frame: Measured at baseline and study completion (week 7) ]
    A brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators.


Secondary Outcome Measures :
  1. Change in killing-related maladaptive cognitions as measured by the Killing Cognitions Scale (KCS) [ Time Frame: Measured at baseline and study completion (week 7) ]
    Assesses killing-related maladaptive cognitions


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Combat veterans
Criteria

Inclusion Criteria:

  • Diagnosis of PTSD
  • Veteran will need to endorse having taken another life in a war zone context
  • Have received some prior evidence-based treatment for PTSD

Exclusion Criteria:

  • Meet current or lifetime criteria for a psychotic disorder
  • 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 Therapy or Cognitive Behavioral Therapy, individuals will need to wait two weeks after they have completed the treatment to enroll in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406834


Locations
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
VA Office of Research and Development
Investigators
Principal Investigator: Shira Maguen, PhD University of California San Francisco/ San Francisco VA Medical Center
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01406834     History of Changes
Other Study ID Numbers: 11-06004
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014

Keywords provided by University of California, San Francisco:
PTSD
Veterans
Killing
Military

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders