Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder
Completed · Not applicable
Conditions studied: Mental Health, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Tobacco Use Disorder
In brief
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 with posttraumatic stress disorder (PTSD). An approach where smoking cessation treatment is integrated into mental health care for PTSD and delivered by mental health providers (experimental condition) will be compared to specialized smoking cessation clinic referral (VA's usual standard of care). Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC versus USC, (b) identify treatment process variables that explain (mediate) observed differences in smoking abstinence rates for the two study conditions, and (c) determine whether cessation from smoking is associated with worsening of symptoms of PTSD and/or depression.
Key facts
- Study ID
- NCT00118534
- Run by
- US Department of Veterans Affairs
- People needed
- 943
- Starts
- 2004-07-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2014-05-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- VA Medical Center, Tuscaloosa — Tuscaloosa, Alabama, United States
- VA San Diego Healthcare System, San Diego — San Diego, California, United States
- VA Medical Center, DC — Washington D.C., District of Columbia, United States
- Southeast Veterans Healthcare System, New Orleans — New Orleans, Louisiana, United States
- VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
- VA Medical Center, Portland — Portland, Oregon, United States
- VA Medical Center, Philadelphia — Philadelphia, Pennsylvania, United States
- VA Medical Center, Providence — Providence, Rhode Island, United States
- Michael E. DeBakey VA Medical Center (152) — Houston, Texas, United States
- VA Medical Center, Hampton — Hampton, Virginia, United States
- VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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