Treatment for the Mental Health Impact of Killing in War

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Treatment for the Mental Health Impact of Killing in War: Augmentation of Existing Evidence-Based Mental Health Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406834
• Other study ID #: 11-06004
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: August 14, 2014
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in psychological symptoms as measured by the Symptom Checklist-90 (SCL-90-R)	A brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators.	Measured at baseline and study completion (week 7)	No
Secondary	Change in killing-related maladaptive cognitions as measured by the Killing Cognitions Scale (KCS)	Assesses killing-related maladaptive cognitions	Measured at baseline and study completion (week 7)	No