Project Background. Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and mortality. Unfortunately, smoking cessation treatment including smoking cessation aids such as nicotine replacement therapy are greatly underutilized. There is a special need to develop effective interventions that target rural Veterans. Veterans living in rural areas are at particular high risk for smoking related morbidity and mortality. Rural Veterans are significantly less likely to access intensive clinic-based smoking cessation care. While the efforts of our group and others have expanded reach of smoking cessation treatment options beyond the clinic to include tele-medicine, cognitive- behavioral telephone counseling, and internet based interventions, it has been suggested that there is a need of more innovative and intensive approaches to smoking cessation in order to improve quit rates, particularly in settings where treatment options are limited such as rural areas. The use of intensive behavioral therapies, such as contingency management (CM), may be a useful component for smoking cessation interventions among rural Veterans. CM has shown efficacy for reducing smoking in other difficult-to-treat populations. Project Objectives. The primary goal of the current study is o evaluate the effectiveness of an intervention that combines evidenced based treatment for smoking cessation with smart-phone based, portable contingency management on smoking rates compared to a contact control intervention in a randomized controlled trial among rural Veteran smokers. Specifically, Veterans will be randomized to receive Abstinence Reinforcement Therapy (ART) which combines evidenced based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM) or a control condition (i.e., TC and NRT alone) that will provide controls for therapist, medication, time and attention effects.
The specific aims and hypotheses are:
AIM 1 : To evaluate the impact of ART on rates of abstinence from cigarettes at 3-month, 6- month, and 12-month post-treatment follow-ups. Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the ART-based intervention than those randomized to the control arm.
AIM 2 : To evaluate the relative cost-effectiveness of the ART intervention. Hypothesis 2: ART based treatment will result in greater cost-effectiveness compared to the control condition as measured by the incremental cost-effectiveness ratio.
AIM 3 : To evaluate potential treatment mediators including self-efficacy-related mechanisms. Hypothesis 3: Increased abstinence associated with ART will be partially mediated by increased self-efficacy compared to the contact-control condition. Project Methods. Proposed is a four year project in which 300 Veteran smokers will be randomized to receive either a multi-component Abstinence Reinforcement Therapy or a contact control intervention. Participating patients will be surveyed at 3-months, 6-months and 12-months post-randomization. The primary outcome of the trial is prolonged self-reported abstinence at the 6 month follow-up verified by cotinine assay.
Rural Veterans are smoking at high rates and are at elevated risk for the development of smoking related illness. Smoking is the most preventable cause of morbidity and mortality in Veterans and is associated with an enormous economic burden. Current evidence suggests a significant underutilization of smoking cessation treatment and use of smoking cessation aids within VHA. Effective smoking cessation programs that target rural Veterans and increase reach over existing approaches are needed. The current application builds upon advances in mHealth technology to increase reach of intensive smoking cessation treatment. Abstinence Reinforcement Therapy (ART) which combines evidenced-based cognitive-behavioral telephone counseling, a tele-medicine clinic for nicotine replacement therapy (NRT), and an intensive behavioral therapy known as contingency management, is expected to significantly reduce smoking among rural Veterans as compared to a control intervention that includes telephone counseling and NRT alone.