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Treatment for the Mental Health Impact of Killing in War

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Veterans Affairs
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01406834
First received: July 19, 2011
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Posttraumatic Stress Disorder (PTSD)
 Behavioral: Impact of Killing CBT Treatment

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in psychological symptoms as measured by the Symptom Checklist-90 (SCL-90-R) [ Time Frame: Measured at baseline and study completion (week 7) ] [ Designated as safety issue: No ]
    A brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators.


Secondary Outcome Measures:
  • Change in killing-related maladaptive cognitions as measured by the Killing Cognitions Scale (KCS) [ Time Frame: Measured at baseline and study completion (week 7) ] [ Designated as safety issue: No ]
    Assesses killing-related maladaptive cognitions


Enrollment: 8
Study Start Date: October 2011
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406834

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01406834     History of Changes
Other Study ID Numbers: 11-06004
Study First Received: July 19, 2011
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013