Mental HealthNCT00118534
Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder
A study testing Integrated Care for Smoking Cessation in PTSD patients in people with Mental Health and Stress Disorders, Post-Traumatic, run by US Department of Veterans Affairs at 11 sites in United States.
Trial 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 with posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Stress Disorders, Post-Traumatic, Substance-Related Disorders
- What is being tested?
- Integrated Care for Smoking Cessation in PTSD patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 943 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
VA Medical Center, Hampton
Hampton, Virginia, 23667
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, 70112
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104
VA Medical Center, Portland
Portland, Oregon, 97201
VA Medical Center, Providence
Providence, Rhode Island, 02908
VA San Diego Healthcare System, San Diego
San Diego, California, 92161
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, 35404
VA Medical Center, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: CSP #519 - Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP)
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.
Read the 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 different methods for delivering smoking cessation treatment will be compared in a randomized, controlled clinical effectiveness trial conducted at four Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care for PTSD who want to quit smoking will be randomly assigned to either (1) guideline-concordant smoking cessation treatment integrated within ongoing mental health care for PTSD, and delivered by mental health providers (Integrated Care (IC), experimental condition), or (2) specialized smoking cessation treatment, delivered separately from PTSD treatment by a smoking cessation clinic (Usual Standard of Care (USC), comparison condition).
Primary Hypothesis: IC will be more effective than USC on measures of smoking-related clinical outcomes.
Secondary Hypothesis: The following treatment process variables will predict smoking abstinence at 12-months post randomization: (a) number of smoking cessation treatment sessions received, (b) type and duration of protocol medications prescribed by providers (bupropion, transdermal nicotine patch, and nicotine gum), (c) degree of subjects' compliance with prescribed protocol medication, and (d) number of quit attempts marked by abstinence of 7 days or more.
Treatment process variables that predict smoking abstinence will be present to a significantly greater degree in IC than USC.
Primary Outcomes: The primary outcome measure will be the point-prevalence of smoking abstinence by self-report for the 7 days prior to assessments, obtained at months 3, 6, 9, and 12 following randomization to study conditions. Verification of smoking abstinence will be obtained by CO readings (abstinence < 10 ppm) obtained at each assessment interval. Salivary cotinine levels (abstinence < 20 ng/ml) will be measured to verify abstinence at months 9 and 12 only, as subjects may still be using nicotine replacement medicines at earlier assessment intervals, confounding cotinine assays.
Study Abstract: Individuals with posttraumatic stress disorder (PTSD) are far more likely to smoke than those without mental illness and they smoke more heavily. Tobacco use likely contributes to the heightened overall mortality and specific risks for smoking related diseases among veterans with PTSD and commonly co-occurring mental disorders.
Symptoms of PTSD and associated mental disorders are linked to the maintenance of tobacco dependence, premature dropout from smoking cessation treatment, and relapse to smoking following quit attempts. Many efficacious tobacco use treatments exist, but a number of barriers limit the effectiveness of current methods for delivering these treatments in VA health care settings, particularly for the mentally ill. Novel approaches to smoking cessation for individuals with PTSD are needed to circumvent these barriers by integrating evidence-based tobacco use treatment into ongoing mental health care. The research proposed here will test the effectiveness of integrating evidence-based treatment for nicotine dependence into mental health care for patients with chronic posttraumatic stress disorder (PTSD). Two different methods for delivering smoking cessation treatment will be compared in a prospective, randomized controlled clinical effectiveness trial conducted at four Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care for PTSD (n=440) will be randomly assigned to either: (1) practice guideline-concordant smoking cessation treatment that is integrated within ongoing mental health care for PTSD and delivered by mental health providers (Integrated Care [IC]) or 2) smoking cessation treatment delivered separately from PTSD treatment by smoking cessation specialists (Usual Standard of Care [USC]). Specific aims of the proposed investigation are (1) to demonstrate that IC is more effective than USC in reducing smoking in psychiatric patients with PTSD and (2) to demonstrate that a number of treatment process variables, including the amount or dose of intervention and patient-specific factors, predict abstinence from tobacco use in smokers with PTSD. Intent-to-treat analyses and analyses for treatment completers will be conducted, using a Generalized Estimating Equations approach. If the study hypothesis is confirmed, system-wide implementation of the experimental intervention (IC) for veterans with PTSD would double the number of patients who stop smoking compared to the usual standard of care for tobacco use disorder. Study findings may have implications for integrating smoking cessation treatment into mental health care for patients with disorders other than PTSD.
- Conditions
- Mental Health, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Tobacco Use Disorder
- Being tested
- Integrated Care for Smoking Cessation in PTSD patients, Standard of Care
- Keywords
- 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
- Medical subject headings
- Psychological Well-Being, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Care for Smoking Cessation in PTSD patientsBehavioural
Also called Integrated Care (IC)
Smoking cessation therapy is integrated with PTSD therapy.
Standard of CareBehavioural
Patients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Integration of smoking cessation therapy with PTSD therapy. Receives: Behavioral: Integrated Care for Smoking Cessation in PTSD patients |
| Arm 2 | Active comparator | Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization
The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine <100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.
Measured: between 6 and 18 months
Secondary outcomes (38)
Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months
A secondary outcome was self-reported 1-year prolonged abstinence between 6 and 18 months post-randomization. Prolonged abstinence excluded tobacco use prior to 6 months post-randomization to allow for initial treatment episode completion and recovery from early relapses. Prolonged abstinence defined non-abstinence as: 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks.
Measured: between 6 and 18 months
Clinician Administered PTSD Scale (CAPS)
Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was CAPS at 18 months. The range is 0-136; five rationally derived severity score ranges for interpreting CAPS total score have been proposed and are as follows: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and >80 = extreme PTSD symptomology. A rationally derived 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change. The above severity ranges and 15-point marker are preliminary (Frank W. Weathers et. al., "Clinician-administered PTSD Scale: A Review of the First Ten Years of Research", Depression and Anxiety 13: 132-156 (2001)). The results are reported in mean change from baseline.
Measured: Baseline and 18 months
PTSD Checklist
Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.
Measured: Baseline and 3 months
PTSD Checklist
Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.
Measured: Baseline and 6 months
PTSD Checklist
Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.
Measured: Baseline and 9 months
PTSD Checklist
Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.
Measured: Baseline and 12 months
PTSD Checklist
Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.
Measured: Baseline and 15 months
PTSD Checklist
Severity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.
Measured: Baseline and 18 months
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.
Measured: Baseline and 3 months
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.
Measured: Baseline and 6 months
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.
Measured: Baseline and 9 months
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.
Measured: Baseline and 12 months
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.
Measured: Baseline and 15 months
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.
Measured: Baseline and 18 months
7-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 3 months
7-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 6 months
7-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 9 months
7-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 12 months
7-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 15 months
7-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 18 months
7-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 3 months
7-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 6 months
7-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 9 months
7-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 12 months
7-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 15 months
7-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 18 months
30-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 3 months
30-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 6 months
30-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 9 months
30-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 12 months
30-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 15 months
30-day Point Prevalence Abstinence - Self Reported
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Measured: 18 months
30-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 3 months
30-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 6 months
30-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 9 months
30-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 12 months
30-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 15 months
30-day Point Prevalence Abstinence - Bio-Verified
Predetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startJul 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 943 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Miles E McFall, PhD, Study chair, VA Puget Sound Health Care System, Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118534
- Sponsor's protocol ID
- 519
- Status last verified
- Apr 2014
- First submitted
- 1 Jul 2005
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Smith MW, Chen S, Siroka AM, Hamlett-Berry K. Using policy to increase prescribing of smoking cessation medications in the VA healthcare system. Tob Control. 2010 Dec;19(6):507-11. doi: 10.1136/tc.2009.035147. Epub 2010 Sep 24.
PubMed 20870742McFall M, Saxon AJ, Malte CA, Chow B, Bailey S, Baker DG, Beckham JC, Boardman KD, Carmody TP, Joseph AM, Smith MW, Shih MC, Lu Y, Holodniy M, Lavori PW; CSP 519 Study Team. Integrating tobacco cessation into mental health care for posttraumatic stress disorder: a randomized controlled trial. JAMA. 2010 Dec 8;304(22):2485-93. doi: 10.1001/jama.2010.1769.
PubMed 21139110Barnett PG, Jeffers A, Smith MW, Chow BK, McFall M, Saxon AJ. Cost-Effectiveness of Integrating Tobacco Cessation Into Post-Traumatic Stress Disorder Treatment. Nicotine Tob Res. 2016 Mar;18(3):267-74. doi: 10.1093/ntr/ntv094. Epub 2015 May 4.
PubMed 25943761Joseph AM, McFall M, Saxon AJ, Chow BK, Leskela J, Dieperink ME, Carmody TP, Beckham JC. Smoking intensity and severity of specific symptom clusters in posttraumatic stress disorder. J Trauma Stress. 2012 Feb;25(1):10-6. doi: 10.1002/jts.21670. Epub 2012 Feb 10.
PubMed 22328334Harder LH, Chen S, Baker DG, Chow B, McFall M, Saxon A, Smith MW. The influence of posttraumatic stress disorder numbing and hyperarousal symptom clusters in the prediction of physical health status in veterans with chronic tobacco dependence and posttraumatic stress disorder. J Nerv Ment Dis. 2011 Dec;199(12):940-5. doi: 10.1097/NMD.0b013e3182392bfb.
PubMed 22134452
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #519 - Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP)
- ClinicalTrials.gov ID
- NCT00118534
- Acronym / sponsor ID
- 519
- Conditions
- Mental Health, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Tobacco Use Disorder
- Keywords
- addictive disorders, clinical trial, cost effectiveness, mental health, military or environmental exposure, multi-site trial, nicotine, nicotine replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 943 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Posted 27 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 different methods for delivering smoking cessation treatment will be compared in a randomized, controlled clinical effectiveness trial conducted at four Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care for PTSD who want to quit smoking will be randomly assigned to either (1) guideline-concordant smoking cessation treatment integrated within ongoing mental health care for PTSD, and delivered by mental health providers (Integrated Care (IC), experimental condition), or (2) specialized smoking cessation treatment, delivered separately from PTSD treatment by a smoking cessation clinic (Usual Standard of Care (USC), comparison condition).
Primary Hypothesis: IC will be more effective than USC on measures of smoking-related clinical outcomes.
Secondary Hypothesis: The following treatment process variables will predict smoking abstinence at 12-months post randomization: (a) number of smoking cessation treatment sessions received, (b) type and duration of protocol medications prescribed by providers (bupropion, transdermal nicotine patch, and nicotine gum), (c) degree of subjects' compliance with prescribed protocol medication, and (d) number of quit attempts marked by abstinence of 7 days or more.
Treatment process variables that predict smoking abstinence will be present to a significantly greater degree in IC than USC.
Primary Outcomes: The primary outcome measure will be the point-prevalence of smoking abstinence by self-report for the 7 days prior to assessments, obtained at months 3, 6, 9, and 12 following randomization to study conditions. Verification of smoking abstinence will be obtained by CO readings (abstinence < 10 ppm) obtained at each assessment interval. Salivary cotinine levels (abstinence < 20 ng/ml) will be measured to verify abstinence at months 9 and 12 only, as subjects may still be using nicotine replacement medicines at earlier assessment intervals, confounding cotinine assays.
Study Abstract: Individuals with posttraumatic stress disorder (PTSD) are far more likely to smoke than those without mental illness and they smoke more heavily. Tobacco use likely contributes to the heightened overall mortality and specific risks for smoking related diseases among veterans with PTSD and commonly co-occurring mental disorders.
Symptoms of PTSD and associated mental disorders are linked to the maintenance of tobacco dependence, premature dropout from smoking cessation treatment, and relapse to smoking following quit attempts. Many efficacious tobacco use treatments exist, but a number of barriers limit the effectiveness of current methods for delivering these treatments in VA health care settings, particularly for the mentally ill. Novel approaches to smoking cessation for individuals with PTSD are needed to circumvent these barriers by integrating evidence-based tobacco use treatment into ongoing mental health care. The research proposed here will test the effectiveness of integrating evidence-based treatment for nicotine dependence into mental health care for patients with chronic posttraumatic stress disorder (PTSD). Two different methods for delivering smoking cessation treatment will be compared in a prospective, randomized controlled clinical effectiveness trial conducted at four Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care for PTSD (n=440) will be randomly assigned to either: (1) practice guideline-concordant smoking cessation treatment that is integrated within ongoing mental health care for PTSD and delivered by mental health providers (Integrated Care [IC]) or 2) smoking cessation treatment delivered separately from PTSD treatment by smoking cessation specialists (Usual Standard of Care [USC]). Specific aims of the proposed investigation are (1) to demonstrate that IC is more effective than USC in reducing smoking in psychiatric patients with PTSD and (2) to demonstrate that a number of treatment process variables, including the amount or dose of intervention and patient-specific factors, predict abstinence from tobacco use in smokers with PTSD. Intent-to-treat analyses and analyses for treatment completers will be conducted, using a Generalized Estimating Equations approach. If the study hypothesis is confirmed, system-wide implementation of the experimental intervention (IC) for veterans with PTSD would double the number of patients who stop smoking compared to the usual standard of care for tobacco use disorder. Study findings may have implications for integrating smoking cessation treatment into mental health care for patients with disorders other than PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Integrated Care for Smoking Cessation in PTSD patientsIntegration of smoking cessation therapy with PTSD therapy. |
| Arm 2 | Active comparator | Behavioral: Standard of CarePer standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Integrated Care for Smoking Cessation in PTSD patientsAlso: Integrated Care (IC)Smoking cessation therapy is integrated with PTSD therapy. | Behavioural | Arm 1 |
| Standard of CarePatients interested in quitting smoking are referred to a separate smoking cessation clinic, per standard of care. | Behavioural | Arm 2 |
Primary outcome
Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization
Time frame: between 6 and 18 months
The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine <100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.
38 secondary outcomes
Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months
Time frame: between 6 and 18 months
Clinician Administered PTSD Scale (CAPS)
Time frame: Baseline and 18 months
PTSD Checklist
Time frame: Baseline and 3 months
PTSD Checklist
Time frame: Baseline and 6 months
PTSD Checklist
Time frame: Baseline and 9 months
PTSD Checklist
Time frame: Baseline and 12 months
PTSD Checklist
Time frame: Baseline and 15 months
PTSD Checklist
Time frame: Baseline and 18 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and 3 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and 6 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and 9 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and 12 months
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and 15 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and 18 months
7-day Point Prevalence Abstinence - Self Reported
Time frame: 3 months
7-day Point Prevalence Abstinence - Self Reported
Time frame: 6 months
7-day Point Prevalence Abstinence - Self Reported
Time frame: 9 months
7-day Point Prevalence Abstinence - Self Reported
Time frame: 12 months
7-day Point Prevalence Abstinence - Self Reported
Time frame: 15 months
7-day Point Prevalence Abstinence - Self Reported
Time frame: 18 months
7-day Point Prevalence Abstinence - Bio-Verified
Time frame: 3 months
7-day Point Prevalence Abstinence - Bio-Verified
Time frame: 6 months
7-day Point Prevalence Abstinence - Bio-Verified
Time frame: 9 months
7-day Point Prevalence Abstinence - Bio-Verified
Time frame: 12 months
7-day Point Prevalence Abstinence - Bio-Verified
Time frame: 15 months
7-day Point Prevalence Abstinence - Bio-Verified
Time frame: 18 months
30-day Point Prevalence Abstinence - Self Reported
Time frame: 3 months
30-day Point Prevalence Abstinence - Self Reported
Time frame: 6 months
30-day Point Prevalence Abstinence - Self Reported
Time frame: 9 months
30-day Point Prevalence Abstinence - Self Reported
Time frame: 12 months
30-day Point Prevalence Abstinence - Self Reported
Time frame: 15 months
30-day Point Prevalence Abstinence - Self Reported
Time frame: 18 months
30-day Point Prevalence Abstinence - Bio-Verified
Time frame: 3 months
30-day Point Prevalence Abstinence - Bio-Verified
Time frame: 6 months
30-day Point Prevalence Abstinence - Bio-Verified
Time frame: 9 months
30-day Point Prevalence Abstinence - Bio-Verified
Time frame: 12 months
30-day Point Prevalence Abstinence - Bio-Verified
Time frame: 15 months
30-day Point Prevalence Abstinence - Bio-Verified
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20870742Smith MW, Chen S, Siroka AM, Hamlett-Berry K. Using policy to increase prescribing of smoking cessation medications in the VA healthcare system. Tob Control. 2010 Dec;19(6):507-11. doi: 10.1136/tc.2009.035147. Epub 2010 Sep 24.
- Results publication: PubMed 21139110McFall M, Saxon AJ, Malte CA, Chow B, Bailey S, Baker DG, Beckham JC, Boardman KD, Carmody TP, Joseph AM, Smith MW, Shih MC, Lu Y, Holodniy M, Lavori PW; CSP 519 Study Team. Integrating tobacco cessation into mental health care for posttraumatic stress disorder: a randomized controlled trial. JAMA. 2010 Dec 8;304(22):2485-93. doi: 10.1001/jama.2010.1769.
- Derived from this study: PubMed 25943761Barnett PG, Jeffers A, Smith MW, Chow BK, McFall M, Saxon AJ. Cost-Effectiveness of Integrating Tobacco Cessation Into Post-Traumatic Stress Disorder Treatment. Nicotine Tob Res. 2016 Mar;18(3):267-74. doi: 10.1093/ntr/ntv094. Epub 2015 May 4.
- Derived from this study: PubMed 22328334Joseph AM, McFall M, Saxon AJ, Chow BK, Leskela J, Dieperink ME, Carmody TP, Beckham JC. Smoking intensity and severity of specific symptom clusters in posttraumatic stress disorder. J Trauma Stress. 2012 Feb;25(1):10-6. doi: 10.1002/jts.21670. Epub 2012 Feb 10.
- Derived from this study: PubMed 22134452Harder LH, Chen S, Baker DG, Chow B, McFall M, Saxon A, Smith MW. The influence of posttraumatic stress disorder numbing and hyperarousal symptom clusters in the prediction of physical health status in veterans with chronic tobacco dependence and posttraumatic stress disorder. J Nerv Ment Dis. 2011 Dec;199(12):940-5. doi: 10.1097/NMD.0b013e3182392bfb.
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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.
Miles E McFall, PhD study chair
VA Puget Sound Health Care System, Seattle
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Care for Smoking Cessation in PTSD patients in people with Mental Health and Stress Disorders, Post-Traumatic, run by US Department of Veterans Affairs at 11 sites 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 5 inclusion and 7 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 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Yes. Results are posted in the registry (first posted 27 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization (time frame: between 6 and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00118534, which also lists 5 linked publications.
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 5 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.