- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01406834
Treatment for the Mental Health Impact of Killing in War
Treatment for the Mental Health Impact of Killing in War: Augmentation of Existing Evidence-Based Mental Health Interventions
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94121
- San Francisco VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Measured at baseline and study completion (week 7)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Measured at baseline and study completion (week 7)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shira Maguen, PhD, University of California San Francisco/ San Francisco VA Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-06004
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