HSR&D Home » Research » IIR 15-092 – HSR&D Study
Pain-related Anxiety Intervention for Smokers with Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans
Lori Anne Bastian, MD MPH
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, CT
Funding Period: February 2017 - January 2022
Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (>50%) with chronic pain continue to smoke. Concomitant efforts to address smoking cessation and pain-related anxiety, via established cognitive behavioral interventions (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 critical need to improve the reach of smoking cessation efforts while simultaneously removing barriers that limit access to and participation in effective interventions.
This study will compare the effectiveness of a telephone-based smoking cessation intervention including CBI for pain to a standard telephone-based smoking cessation intervention among Veteran smokers with moderate to severe pain, a pain intensity >4.
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 compared to standard smoking cessation counseling (SMK-STD).
AIM 2: Evaluate the impact of SMK-CBI on pain intensity and pain interference among Veterans at 6- and12-months compared to SMK-STD.
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 compared to SMK-STD.
Proposed is a randomized comparative effectiveness trial with a two-group design in which 370 Veteran smokers with moderate to severe 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 or 2) SMK-STD, a contact-equivalent intervention that provides standard smoking cessation telephone counseling.
Subjects with pain intensity > 4, current tobacco use, and receiving care at VACHS will be identified by administrative data. An introductory opt-out letter will be sent to prospective patients informing them of the study. Subjects who have not opted out will receive a phone call from a research assistant to further assess inclusion criteria. Enrolled subjects will be randomized into the SMK-CBI or SMK-STD arm. Each participant will complete 5 telephone-based sessions within 12 weeks. Subjects will be surveyed three times: enrollment, 6-months post-intervention and 12-months post-intervention for pain intensity, self-efficacy to quit, demographics, smoking history/habits, depression, smoking status, nicotine withdrawal symptoms, use of intervention materials, and intervention acceptability. Based on follow-up surveys, self-reported non-smokers will be asked to provide a saliva sample at their next clinic visit following the follow-up surveys.
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.
External Links for this Project
NIH ReporterGrant Number: I01HX001875-01
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DRA: Substance Use Disorders
DRE: TRL - Applied/Translational, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Anxiety Disorders, Gender Differences, Pain, Telemedicine/Telehealth
MeSH Terms: none