Posttraumatic Stress Disorder (PTSD)NCT01406834
Treatment for the Mental Health Impact of Killing in War
An observational study of Posttraumatic Stress Disorder (PTSD), run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Impact of Killing CBT Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Combat veterans
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: 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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Impact of Killing CBT Treatment
- Keywords
- PTSD, Veterans, Killing, Military
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of Killing CBT TreatmentBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and study completion (week 7)
Secondary outcomes (1)
Change in killing-related maladaptive cognitions as measured by the Killing Cognitions Scale (KCS)
Assesses killing-related maladaptive cognitions
Measured: Measured at baseline and study completion (week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Shira Maguen, PhD, Principal investigator, University of California San Francisco/ San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406834
- Sponsor's protocol ID
- 11-06004
- Status last verified
- Aug 2014
- First submitted
- 19 Jul 2011
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for the Mental Health Impact of Killing in War: Augmentation of Existing Evidence-Based Mental Health Interventions
- ClinicalTrials.gov ID
- NCT01406834
- Acronym / sponsor ID
- 11-06004
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- PTSD, Veterans, Killing, Military
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Combat veterans
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of Killing CBT TreatmentTreatment will include six, one hours sessions with a licensed clinical psychologist or an advanced postdoctoral fellow under the close supervision of a licensed psychologist. | Behavioural | – |
Primary outcome
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.
1 secondary outcome
Change in killing-related maladaptive cognitions as measured by the Killing Cognitions Scale (KCS)
Time frame: Measured at baseline and study completion (week 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shira Maguen, PhD principal investigator
University of California San Francisco/ San Francisco VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Stress Disorder (PTSD), run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychological symptoms as measured by the Symptom Checklist-90 (SCL-90-R) (time frame: Measured at baseline and study completion (week 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.