Overview

This trial is active, not recruiting.

Conditions veteran, smoking cessation
Treatments abstinence reinforcement therapy (art), telephone counseling and nrt
Sponsor VA Office of Research and Development
Start date November 2013
End date October 2016
Trial size 300 participants
Trial identifier NCT01723163, IIR 12-365

Summary

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 300 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Abstinence Reinforcement Therapy (ART)
abstinence reinforcement therapy (art) Intervention
Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
(Other)
Telephone Counseling
telephone counseling and nrt Control
Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)

Primary Outcomes

Measure
Primary outcome measure will be quality-adjusted life years (QALYs). The QALY is a standardized effectiveness measure that allows for the comparison of the value of a particular intervention to a broad range of other potential health care investments
time frame: 12 month post treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Enrolled in the Durham VA for ongoing care. - Current smokers planning to quit smoking in the next 30 days. Exclusion Criteria: - Active diagnosis of psychosis documented in the medical record. - Does not have access to a telephone. - Severely impaired hearing or speech (Veterans must be able to respond to phone calls).

Additional Information

Official title Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
Principal investigator Patrick S Calhoun, PhD
Description 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 300 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) 4 on changing health behavior at the population level, investigators must identify new and innovative strategies to increase treatment intensity, access, and participation. Specific aims are to: AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence 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) AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted life years (QALY). 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: 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. Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression, alcohol abuse) and pain symptoms on treatment outcome across the two conditions.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.