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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01406834
Other study ID # 11-06004
Secondary ID
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


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
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