Smoking Cessation Clinical Trial
Official title:
Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
The primary goal of the current study is to evaluate the effectiveness of a combined
tele-health and contingency management (CM) intervention that investigators are calling
Abstinence Reinforcement Therapy (ART). Proposed is a comparative effectiveness trial with a
two-group design in which 310 Veteran smokers will be randomized to either:
ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines
guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for
access to nicotine replacement (NRT), and intensive behavioral therapy through mobile
contingency management.
TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide
controls for therapist, medication, time and attention effects. The tele-health intervention
provides the same guideline based cognitive-behavioral smoking cessation telephone counseling
(TC), and tele-medicine clinic for access to NRT as in the ART intervention.
The addition of contingency management (CM) to existing evidenced-based tele-health smoking
cessation interventions is expected to be a cost-effective way to increase the reach of
intensive smoking cessation treatment. CM is an intensive behavioral therapy that provides
positive reinforcers (e.g., money, vouchers) to individuals misusing substances contingent
upon objective evidence of abstinence from drug use. Implementation of CM has been limited
because of the need to verify abstinence multiple times daily with a clinic based carbon
monoxide (CO) monitor. As a result, CM approaches have largely been relegated to inpatient
and day treatment programs. The application of emerging smart-phone technology, however, can
overcome this barrier. Investigators have developed a smart-phone application which allows a
participant to video themselves several times daily while using a small CO monitor and to
transmit the data to a secure server. This innovation has made the use of CM for outpatient
smoking cessation portable and feasible, i.e., mobile CM (mCM). Thus, the primary goal of the
current study is to evaluate the effectiveness of a combined tele-health and CM intervention
that investigators are calling Abstinence Reinforcement Therapy (ART). Proposed is a
comparative effectiveness trial with a two-group design in which 310 Veteran smokers will be
randomized to either:
ABSTINENCE REINFORCEMENT THERAPY (ART) a proactive tele-health intervention that combines
guideline based cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for
access to nicotine replacement (NRT), and intensive behavioral therapy through mobile
contingency management.
TELE-HEALTH FOR SMOKING CESSATION a proactive tele-health intervention that will provide
controls for therapist, medication, time and attention effects. The tele-health intervention
provides the same guideline based cognitive-behavioral smoking cessation telephone counseling
(TC), and tele-medicine clinic for access to NRT as in the ART intervention.
Both of the proposed interventions are designed in accordance with national smoking cessation
guidelines. Tele-health smoking cessation interventions are typically less intensive than
clinic based specialty care, but increase reach of services through bypassing barriers to
participation such as geographical distance from VA care. The addition of mCM to an
evidence-based tele-health smoking intervention will significantly increase the intensity of
the intervention and is predicted to increase efficacy. If cessation programs are to have
significant impact (Impact = Reach X Efficacy) on changing health behavior at the population
level, investigators must identify new and innovative strategies to increase treatment
intensity, access, and participation.
The primary aim is to evaluate the impact of ART on rates of abstinence from cigarettes at
3-month, 6-month, and 12-month post-randomization follow-ups.
Hypothesis 1: Abstinence rates will be significantly higher among Veterans randomized to the
ART-based intervention than those randomized to the Tele-health alone intervention (primary
end-point; self-reported and bio-verified prolonged abstinence at the 6-month follow-up).
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