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Smoking cessation and care management for veterans with posttraumatic stress disorder: a study protocol for a randomized controlled trial.

ABSTRACT: Smoking remains the leading cause of preventable illness and mortality in the United States. Individuals with Posttraumatic Stress Disorder (PTSD) have smoking rates higher than that of others and fewer individuals with PTSD have quit smoking. This randomized controlled trial was designed to test the effectiveness of integrating telehealth care management and smoking cessation with motivational interviewing for Veterans with PTSD.All smokers with PTSD, regardless of their desire to quit, were invited to participate. Enrollment occurred between November 2009 and April 2013. Target enrollment was 120 participants. Enrolled participants were randomized to either the control group, receiving usual care including a telehealth PTSD program, with a device that delivered PTSD information and in-home care management, or the intervention group, which included (1) a telehealth PTSD program, (2) motivational interviewing-based smoking cessation curricula via the telehealth device, and (3) weekly motivational interviewing counseling phone calls. Outcomes are self-reported 24-hour quit attempts, progression along the stages of change and 7-day point prevalence quit smoking rates for the intervention group compared to usual care alone. Secondary outcomes include participants' perception of care coordination, patient satisfaction with motivational interviewing, PTSD symptoms, pain, depression and quality of life.Motivational interviewing has been shown to increase readiness for change and smoking cessation care has been shown to be more successful when incorporated into in-person mental health care. Our study builds on previous studies. It integrates a written smoking cessation curriculum and phone-based motivational interviewing counseling into an established PTSD home telehealth care coordination program. This paper describes the design and methods of our randomized control trial.ClinicalTrials.gov, NCT00908882, May 22, 2009.

SUBMITTER: Peterson J

PROVIDER: S-EPMC4325951 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Smoking cessation and care management for veterans with posttraumatic stress disorder: a study protocol for a randomized controlled trial.

Peterson Jamie J Prochazka Allan V AV Battaglia Catherine C

BMC health services research 20150201

<h4>Background</h4>Smoking remains the leading cause of preventable illness and mortality in the United States. Individuals with Posttraumatic Stress Disorder (PTSD) have smoking rates higher than that of others and fewer individuals with PTSD have quit smoking. This randomized controlled trial was designed to test the effectiveness of integrating telehealth care management and smoking cessation with motivational interviewing for Veterans with PTSD.<h4>Methods/design</h4>All smokers with PTSD, r ...[more]

PMID: 25638351

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Project description:IntroductionImprovement in posttraumatic stress disorder (PTSD) is associated with better health behavior such as better medication adherence and greater use of nutrition and weight loss programs. However, it is not known if reducing PTSD severity is associated with smoking cessation, a poor health behavior common in patients with PTSD.Aims and methodsVeterans Health Affairs (VHA) medical record data (2008-2015) were used to identify patients with PTSD diagnosed in specialty care. Clinically meaningful PTSD improvement was defined as ≥20 point PTSD Checklist (PCL) decrease from the first PCL ≥50 and the last available PCL within 12 months and at least 8 weeks later. The association between clinically meaningful PTSD improvement and smoking cessation within 2 years after baseline among 449 smokers was estimated in Cox proportional hazard models. Entropy balancing controlled for confounding.ResultsOn average, patients were 39.4 (SD = 12.9) years of age, 86.6% were male and 71.5% were white. We observed clinically meaningful PTSD improvement in 19.8% of participants. Overall, 19.4% quit smoking in year 1 and 16.6% in year 2. More patients with versus without clinically meaningful PTSD improvement stopped smoking (n = 36, cumulative incidence = 40.5% vs. 111, cumulative incidence = 30.8%, respectively). After controlling for confounding, patients with versus without clinically meaningful PTSD improvement were more likely to stop smoking within 2 years (hazard ratio = 1.57; 95% confidence interval: 1.04-2.36).ConclusionsPatients with clinically meaningful PTSD improvement were significantly more likely to stop smoking. Further research should determine if targeted interventions are needed or whether improvement in PTSD symptoms is sufficient to enable smoking cessation.ImplicationsPatients with PTSD are more likely to develop chronic health conditions such as heart disease and diabetes. Poor health behaviors, including smoking, partly explain the risk for chronic disease in this patient population. Our results demonstrate that clinically meaningful PTSD improvement is followed by greater likelihood of smoking cessation. Thus, PTSD treatment may enable healthier behaviors and reduce risk for smoking-related disease.

Project description:Most smokers with mental illness do not receive tobacco cessation treatment.To determine whether integrating smoking cessation treatment into mental health care for veterans with posttraumatic stress disorder (PTSD) improves long-term smoking abstinence rates.A randomized controlled trial of 943 smokers with military-related PTSD who were recruited from outpatient PTSD clinics at 10 Veterans Affairs medical centers and followed up for 18 to 48 months between November 2004 and July 2009.Smoking cessation treatment integrated within mental health care for PTSD delivered by mental health clinicians (integrated care [IC]) vs referral to Veterans Affairs smoking cessation clinics (SCC). Patients received smoking cessation treatment within 3 months of study enrollment.Smoking outcomes included 12-month bioverified prolonged abstinence (primary outcome) and 7- and 30-day point prevalence abstinence assessed at 3-month intervals. Amount of smoking cessation medications and counseling sessions delivered were tested as mediators of outcome. Posttraumatic stress disorder and depression were repeatedly assessed using the PTSD Checklist and Patient Health Questionnaire 9, respectively, to determine if IC participation or quitting smoking worsened psychiatric status.Integrated care was better than SCC on prolonged abstinence (8.9% vs 4.5%; adjusted odds ratio, 2.26; 95% confidence interval [CI], 1.30-3.91; P = .004). Differences between IC vs SCC were largest at 6 months for 7-day point prevalence abstinence (78/472 [16.5%] vs 34/471 [7.2%], P < .001) and remained significant at 18 months (86/472 [18.2%] vs 51/471 [10.8%], P < .001). Number of counseling sessions received and days of cessation medication used explained 39.1% of the treatment effect. Between baseline and 18 months, psychiatric status did not differ between treatment conditions. Posttraumatic stress disorder symptoms for quitters and nonquitters improved. Nonquitters worsened slightly on the Patient Health Questionnaire 9 relative to quitters (differences ranged between 0.4 and 2.1, P = .03), whose scores did not change over time.Among smokers with military-related PTSD, integrating smoking cessation treatment into mental health care compared with referral to specialized cessation treatment resulted in greater prolonged abstinence.clinicaltrials.gov Identifier: NCT00118534.

Project description:OBJECTIVE:The aim of this research was to determine whether augmenting standard smoking cessation treatment by wearing an active nicotine patch before the smoking quit date improves rates of smoking cessation in individuals with posttraumatic stress disorder (PTSD) and to explore mechanisms of treatment response such as decreased cigarette craving and symptom relief from smoking. METHODS:This was a double-blind parallel randomized controlled trial in 81 people with PTSD who smoked cigarettes. Participants were recruited from Veterans Affairs outpatient clinics and flyers in the community. Participants provided ecological momentary assessments (EMAs) of PTSD symptoms, smoking withdrawal symptoms, and cravings before and after smoking a cigarette during one week of ad lib smoking and then three weeks of either a nicotine patch (n?=?37) or placebo patch (n?=?44) preceding the quit date. All participants received standard pharmacotherapy and behavioral treatment for smoking cessation after the quit date. To test the efficacy of nicotine patch preloading for engaging proposed treatment targets during the pre-quit phases, we used multilevel models to compare post-smoking changes in symptoms and cravings during the preloading phases to post-smoking changes reported during the ad lib smoking phase. RESULTS:There was no significant difference in quit rates across the two conditions on the primary outcome of seven-day point prevalence smoking abstinence bioverified with breath carbon monoxide at six weeks post-quit date. In a multivariable multilevel model pre- to post-cigarette changes in PTSD symptom clusters, smoking withdrawal symptoms, and cravings, there was a significant interaction between treatment phase and condition. Relative to participants in the placebo condition, participants in the nicotine patch condition experienced diminished relief from PTSD reexperiencing symptoms, smoking withdrawal symptoms, and cigarette craving after smoking a cigarette. CONCLUSIONS:Relative to placebo patch preloading, nicotine patch preloading diminished the reinforcing effects of smoking cigarettes. However, the low quit rates in both conditions suggest that nicotine patch preloading is not a sufficiently intensive treatment for achieving smoking cessation in people with PTSD. TRIAL REGISTRATION:clinicaltrials.gov: NCT00625131.

Project description:BackgroundCurrent research in behavioral cardiology reveals a significant association between posttraumatic stress disorder (PTSD) and increased risk for cardiovascular disease and mortality; however, the underlying mechanisms remain poorly understood. We hypothesized that patients with PTSD would exhibit endothelial dysfunction, a potential mechanism involved in the development and progression of cardiovascular disease.Methods and resultsA total of 214 outpatients treated at the San Francisco Veterans Affairs Medical Center underwent tests of endothelial function and evaluation for PTSD. Flow-mediated vasodilation of the brachial artery was performed to assess endothelial function, and current PTSD status was defined by the PTSD Checklist, based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition), with a score ≥40. Multivariable linear regression models were used to estimate the association between PTSD status and endothelial function. Patients with PTSD (n=67) were more likely to be male (99% versus 91%, P=0.04) and to have depression (58% versus 8%, P<0.0001) and were less likely to be on an angiotensin-converting enzyme inhibitor (17% versus 36%, P=0.007) or β-blocker treatment (25% versus 41%, P=0.03). Univariate analysis demonstrated that patients with PTSD had significantly lower flow-mediated vasodilation (5.8±3.4% versus 7.5±3.7%; P=0.003); furthermore, lower flow-mediated vasodilation was associated with increasing age (P=0.008), decreasing estimated glomerular filtration rate (P=0.003), hypertension (P=0.002), aspirin (P=0.03), and β-blocker treatments (P=0.01). In multivariable analysis, PTSD remained independently associated with lower flow-mediated vasodilation (P=0.0005).ConclusionsAfter adjusting for demographic, comorbidity, and treatment characteristics, PTSD remained associated with worse endothelial function in an outpatient population. Whether poor endothelial function contributes to the higher risk of cardiovascular disease in patients with PTSD deserves further study.

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Smoking cessation and care management for veterans with posttraumatic stress disorder: a study protocol for a randomized controlled trial.

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Smoking cessation and care management for veterans with posttraumatic stress disorder: a study protocol for a randomized controlled trial.

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