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Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01723163
Enrollment
310
Registered
2012-11-07
Start date
2013-11-21
Completion date
2017-09-30
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation, Veteran

Keywords

veteran, smoking cessation

Brief 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 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.

Detailed 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 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).

Interventions

BEHAVIORALAbstinence Reinforcement Therapy (ART)

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)

BEHAVIORALTelephone Counseling and NRT

Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up6-month post-treatmentNon-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.

Countries

United States

Participant flow

Recruitment details

Participants who did not complete a follow-up were not prohibited from participating in the remaining study follow-up periods.

Participants by arm

ArmCount
Intervention
Abstinence Reinforcement Therapy (ART) Abstinence Reinforcement Therapy (ART): 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)
156
Control
Telephone Counseling Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
154
Total310

Withdrawals & dropouts

PeriodReasonFG000FG001
12-Month Follow-upDeath10
12-Month Follow-upUnable to Contact2328
3-Month Follow-upUnable to Contact1219
3-Month Follow-upWithdrawal by Subject10
6-Month Follow-upDeath10
6-Month Follow-upUnable to Contact1715
Treatment PhaseWithdrawal by PI51
Treatment PhaseWithdrawal by Subject146

Baseline characteristics

CharacteristicControlInterventionTotal
Age, Continuous56 years
STANDARD_DEVIATION 11
57 years
STANDARD_DEVIATION 11
57 years
STANDARD_DEVIATION 11
Distance to nearest VA hospital or clinic (miles)
0-20 Miles
53 Participants56 Participants109 Participants
Distance to nearest VA hospital or clinic (miles)
101 Miles or more
3 Participants2 Participants5 Participants
Distance to nearest VA hospital or clinic (miles)
21-40 Miles
66 Participants49 Participants115 Participants
Distance to nearest VA hospital or clinic (miles)
41-60 Miles
21 Participants35 Participants56 Participants
Distance to nearest VA hospital or clinic (miles)
61-80 Miles
6 Participants9 Participants15 Participants
Distance to nearest VA hospital or clinic (miles)
81-100 Miles
5 Participants5 Participants10 Participants
Education
High School or less
51 Participants55 Participants106 Participants
Education
More than High School
103 Participants101 Participants204 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
152 Participants153 Participants305 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Fagerstrom Test for Nicotine Dependence4 units on a scale
STANDARD_DEVIATION 2
4 units on a scale
STANDARD_DEVIATION 2
4 units on a scale
STANDARD_DEVIATION 2
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
90 Participants85 Participants175 Participants
Race (NIH/OMB)
More than one race
6 Participants8 Participants14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
56 Participants61 Participants117 Participants
Self efficacy scale for quitting smoking in next 6 months6 units on a scale
STANDARD_DEVIATION 1
6 units on a scale
STANDARD_DEVIATION 1
6 units on a scale
STANDARD_DEVIATION 1
Sex: Female, Male
Female
17 Participants17 Participants34 Participants
Sex: Female, Male
Male
137 Participants139 Participants276 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 1560 / 154
other
Total, other adverse events
0 / 1560 / 154
serious
Total, serious adverse events
0 / 1560 / 154

Outcome results

Primary

Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up

Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.

Time frame: 6-month post-treatment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Abstinence or Non-Abstinence at 6-month Follow-upNon-Abstinent77 Participants
InterventionNumber of Participants With Abstinence or Non-Abstinence at 6-month Follow-upAbstinent38 Participants
InterventionNumber of Participants With Abstinence or Non-Abstinence at 6-month Follow-upMissing41 Participants
ControlNumber of Participants With Abstinence or Non-Abstinence at 6-month Follow-upAbstinent40 Participants
ControlNumber of Participants With Abstinence or Non-Abstinence at 6-month Follow-upNon-Abstinent83 Participants
ControlNumber of Participants With Abstinence or Non-Abstinence at 6-month Follow-upMissing31 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026