Treatment for the Mental Health Impact of Killing in War

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01406834
• Collaborator: US Department of Veterans Affairs (U.S. Fed)
• Enrollment: 8
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 0.4

Study Details

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	Phase
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: Oct 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Outcome Measures

Primary Outcome Measures

1. Change in psychological symptoms as measured by the Symptom Checklist-90 (SCL-90-R) [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) [Measured at baseline and study completion (week 7)]

   Assesses killing-related maladaptive cognitions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	San Francisco VA Medical Center	San Francisco	California	United States	94121

Sponsors and Collaborators

• University of California, San Francisco
• US Department of Veterans Affairs

Investigators

• Principal Investigator: Shira Maguen, PhD, University of California San Francisco/ San Francisco VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01406834
• Other Study ID Numbers: 11-06004
• First Posted: Aug 1, 2011
• Last Update Posted: Aug 18, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by University of California, San Francisco: PTSD; Veterans; Killing; Military
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Aug 18, 2014