NCT01406834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

July 19, 2011

Last Update Submit

August 14, 2014

Conditions

Keywords

PTSDVeteransKillingMilitary

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Change in killing-related maladaptive cognitions as measured by the Killing Cognitions Scale (KCS)

    Measured at baseline and study completion (week 7)

Interventions

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Combat veterans

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Shira Maguen, PhD

    University of California San Francisco/ San Francisco VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2011

First Posted

August 1, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations