Sarah M Wilson1, Lauren P Hair2, Jeffrey S Hertzberg2, Angela C Kirby3, Maren K Olsen4, Jennifer H Lindquist4, Matthew L Maciejewski4, Jean C Beckham5, Patrick S Calhoun6. 1. VA Mid-Atlantic Mental Illness Research, Education and Clinical Center (MIRECC), Durham, NC 27705, United States; Durham VA Medical Center, Durham, NC 27705, United States. Electronic address: sarah.wilson@duke.edu. 2. Durham VA Medical Center, Durham, NC 27705, United States. 3. VA Mid-Atlantic Mental Illness Research, Education and Clinical Center (MIRECC), Durham, NC 27705, United States; Durham VA Medical Center, Durham, NC 27705, United States. 4. Center for Health Services Research in Primary Care, 508 Fulton Street, Durham, NC 27705, United States. 5. VA Mid-Atlantic Mental Illness Research, Education and Clinical Center (MIRECC), Durham, NC 27705, United States; Durham VA Medical Center, Durham, NC 27705, United States; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, United States. 6. VA Mid-Atlantic Mental Illness Research, Education and Clinical Center (MIRECC), Durham, NC 27705, United States; Durham VA Medical Center, Durham, NC 27705, United States; Center for Health Services Research in Primary Care, 508 Fulton Street, Durham, NC 27705, United States; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, United States.
Abstract
INTRODUCTION: Smoking is the most preventable cause of morbidity and mortality in U.S. veterans. Rural veterans in particular have elevated risk for smoking and smoking-related illness. However, these veterans underutilize smoking cessation treatment, which suggests that interventions for rural veterans should optimize efficacy and reach. OBJECTIVE: The primary goal of the current study is to 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. METHODS:Smokers were identified using VHA electronic medical records and recruited proactively via telephone. Participants (N=310) are randomized to either ART or a best practice control consisting of telephone counseling and telemedicine. Participating patients will be surveyed at 3-months, 6-months and 12-months post-randomization. The primary outcome measure is self-reported and biochemically validated prolonged abstinence at 6-month follow-up. DISCUSSION: This trial is designed to test the relative effectiveness of ART compared to a telehealth-only comparison group. Dissemination of this mHealth intervention for veterans in a variety of settings would be warranted if ART improves smoking outcomes for rural veterans and is cost-effective. Published by Elsevier Inc.
RCT Entities:
INTRODUCTION: Smoking is the most preventable cause of morbidity and mortality in U.S. veterans. Rural veterans in particular have elevated risk for smoking and smoking-related illness. However, these veterans underutilize smoking cessation treatment, which suggests that interventions for rural veterans should optimize efficacy and reach. OBJECTIVE: The primary goal of the current study is to 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. METHODS: Smokers were identified using VHA electronic medical records and recruited proactively via telephone. Participants (N=310) are randomized to either ART or a best practice control consisting of telephone counseling and telemedicine. Participating patients will be surveyed at 3-months, 6-months and 12-months post-randomization. The primary outcome measure is self-reported and biochemically validated prolonged abstinence at 6-month follow-up. DISCUSSION: This trial is designed to test the relative effectiveness of ART compared to a telehealth-only comparison group. Dissemination of this mHealth intervention for veterans in a variety of settings would be warranted if ART improves smoking outcomes for rural veterans and is cost-effective. Published by Elsevier Inc.
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