Status:
COMPLETED
Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Mental Health
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary study objective is to conduct a prospective, randomized controlled clinical trial that compares the effectiveness of two approaches for delivering smoking cessation treatment for veterans ...
Detailed Description
Intervention: The research will test the effectiveness of integrating evidence-based, efficacious treatments for tobacco use disorder into mental health care for patients with chronic PTSD. Two differ...
Eligibility Criteria
Inclusion
- Receive a minimum of four mental health treatment sessions from the SOPP that span at least a 1-month interval
- SOPP treatment plan must indicate intent to deliver ongoing PTSD care for at least 1 year, including visits at least once per month
- Diagnosis of PTSD resulting from military trauma using DSM-IV criteria
- Current nicotine use, smoking greater at least 10 cigarettes per day for at least 16 of the past 30 days prior to randomization
- Demonstrated motivation to quit smoking
Exclusion
- Use of smokeless tobacco or smoke pipes or cigars
- Any psychotic disorder that is not in remission
- Bipolar disorder that is not in remission
- Any substance dependence disorder that is not in remission (current substance abuse disorder and substance dependence disorder in remission for more than 1 month are not exclusions)
- Imminent risk for suicide or violence, as determined during routine assessment by SOPP clinical staff
- Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions), as determined during routine assessment by SOPP clinical staff
- Gross impairment from organic mental disorder, as determined during routine assessment by SOPP clinical staff
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
943 Patients enrolled
Trial Details
Trial ID
NCT00118534
Start Date
July 1 2004
End Date
June 1 2009
Last Update
May 5 2014
Active Locations (11)
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1
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, United States, 35404
2
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
3
VA Medical Center, DC
Washington D.C., District of Columbia, United States, 20422
4
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States, 70112