Pain-related Anxiety Invervention for Smokers with Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans

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Impacts: Cigarette smoking is the single greatest cause of preventable deaths in the U.S. Military service is a risk factor for smoking and approximately 20% of US Veterans are smokers. Pain is frequently reported by Veterans and research suggests smoking is associated with concurrent pain intensity. Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Background: Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (>50%) with chronic pain continue to smoke. Recently, Hooten et al tested a standard smoking cessation protocol augmented with a cognitive behavioral intervention (CBI) targeting coping strategies for emotional distress to address smoking among hospitalized patients with chronic pain. Results revealed that 20% of the patients in the CBI condition were abstinent from smoking compared to none in the control group at the 6 month follow-up. Concomitant efforts to address smoking cessation and pain-related anxiety, via established CBIs, have the potential to provide smokers with pain the requisite skills to navigate the smoking cessation process and manage the associated anxiety-related cues that interfere with efforts to quit. Given the widespread prevalence of smoking and its staggering impact on Veteran health, VHA has highlighted the need for adopting a public health approach to smoking cessation. From a public health perspective, the impact is defined as Reach (i.e., number of Veterans who access/receive an intervention) multiplied by Efficacy (effect size of an intervention). Efforts to improve the reach of smoking cessation efforts while simultaneously removing barriers that limit access to and participation in effective interventions is critical to improving cessation rates at the population level. The current investigation combines the established efficacy of a CBI and the reach of a proactive telephone-delivered intervention. This study aims to test the telephone delivery of a CBI, for smoking cessation among Veteran smokers with chronic pain. Objectives: AIM 1: Evaluate the impact of smoking cessation plus CBI (SMK-CBI) on cigarette abstinence rates among Veterans with chronic pain at 6 and 12-months. Hypotheses 1.1 & 1.2: Prolonged abstinence rates (H 1.1) and 7-day point prevalence abstinence rates (H 1.2) will be significantly higher among Veterans with chronic pain who receive SMK-CBI compared with those in 2) smoking cessation telephone counseling control (SMK Control). AIM 2: Evaluate the impact of SMK-CBI on pain intensity and pain interference among Veterans at 6- and12- months. Hypothesis 2.1: Veterans in SMK-CBI will report significantly lower usual pain intensity and pain interference relative to SMK Control. AIM 3: Assess whether change in self-efficacy and pain-related anxiety mediate the impact of SMK-CBI on smoking cessation in Veterans with pain at 6- and 12-months. Hypothesis 3.1: The relationship between SMK-CBI and reported smoking cessation will be mediated by self- efficacy and pain-related anxiety.In addition, teaching these skills will improve pain-related anxiety. Methods: Proposed is a randomized comparative effectiveness trial with a two-group design in which 370 Veteran smokers with chronic pain will be randomized to either: 1) SMK-CBI, an intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) SMK Control, a contact-equivalent control that provides standard smoking cessation telephone counseling and a tele-medicine clinic for accessing NRT.