Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mental Health Stress Disorders, Post-Traumatic Substance-Related Disorders Tobacco Use Disorder |
Behavioral: Integrated Care for Smoking Cessation in PTSD patients Behavioral: Standard of Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CSP #519 - Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP) |
- Prolonged smoking cessation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 945 |
| Study Start Date: | July 2004 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Integration of smoking cessation therapy with PTSD therapy.
|
Behavioral: Integrated Care for Smoking Cessation in PTSD patients
Smoking cessation therapy is integrated with PTSD therapy.
Other Name: Integrated Care (IC)
|
|
Active Comparator: 2
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
Behavioral: Standard of Care
Patients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| United States, Alabama | |
| VA Medical Center, Tuscaloosa | |
| Tuscaloosa, Alabama, United States, 35404 | |
| United States, California | |
| VA San Diego Healthcare System, San Diego | |
| San Diego, California, United States, 92161 | |
| United States, District of Columbia | |
| VA Medical Center, DC | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Louisiana | |
| Southeast Veterans Healthcare System, New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Minnesota | |
| VA Medical Center, Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Oregon | |
| VA Medical Center, Portland | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| VA Medical Center, Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| VA Medical Center, Providence | |
| Providence, Rhode Island, United States, 02908 | |
| United States, Texas | |
| Michael E. DeBakey VA Medical Center (152) | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| VA Medical Center, Hampton | |
| Hampton, Virginia, United States, 23667 | |
| United States, Washington | |
| VA Puget Sound Health Care System, Seattle | |
| Seattle, Washington, United States, 98108 | |
| Study Chair: | Miles E McFall, PhD | VA Puget Sound Health Care System, Seattle |
More Information
No publications provided by Department of Veterans Affairs
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | McFall, Miles - Study Chair, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00118534 History of Changes |
| Other Study ID Numbers: | 519 |
| Study First Received: | July 1, 2005 |
| Last Updated: | January 13, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
addictive disorders clinical trial cost effectiveness mental health military or environmental exposure multi-site trial nicotine nicotine replacement |
post traumatic stress post traumatic stress disorder psychiatric psychological PTSD smoking cessation smoking cessation medications substance abuse |
Additional relevant MeSH terms:
|
Smoking Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Tobacco Use Disorder |
Substance-Related Disorders Habits Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013