Smoking Cessation, Veteran
Conditions
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
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)
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up | 6-month post-treatment | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-Month Follow-up | Death | 1 | 0 |
| 12-Month Follow-up | Unable to Contact | 23 | 28 |
| 3-Month Follow-up | Unable to Contact | 12 | 19 |
| 3-Month Follow-up | Withdrawal by Subject | 1 | 0 |
| 6-Month Follow-up | Death | 1 | 0 |
| 6-Month Follow-up | Unable to Contact | 17 | 15 |
| Treatment Phase | Withdrawal by PI | 5 | 1 |
| Treatment Phase | Withdrawal by Subject | 14 | 6 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 56 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 Participants | 56 Participants | 109 Participants |
| Distance to nearest VA hospital or clinic (miles) 101 Miles or more | 3 Participants | 2 Participants | 5 Participants |
| Distance to nearest VA hospital or clinic (miles) 21-40 Miles | 66 Participants | 49 Participants | 115 Participants |
| Distance to nearest VA hospital or clinic (miles) 41-60 Miles | 21 Participants | 35 Participants | 56 Participants |
| Distance to nearest VA hospital or clinic (miles) 61-80 Miles | 6 Participants | 9 Participants | 15 Participants |
| Distance to nearest VA hospital or clinic (miles) 81-100 Miles | 5 Participants | 5 Participants | 10 Participants |
| Education High School or less | 51 Participants | 55 Participants | 106 Participants |
| Education More than High School | 103 Participants | 101 Participants | 204 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 152 Participants | 153 Participants | 305 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Fagerstrom Test for Nicotine Dependence | 4 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 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 90 Participants | 85 Participants | 175 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 61 Participants | 117 Participants |
| Self efficacy scale for quitting smoking in next 6 months | 6 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 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 137 Participants | 139 Participants | 276 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 156 | 0 / 154 |
| other Total, other adverse events | 0 / 156 | 0 / 154 |
| serious Total, serious adverse events | 0 / 156 | 0 / 154 |
Outcome results
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up | Non-Abstinent | 77 Participants |
| Intervention | Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up | Abstinent | 38 Participants |
| Intervention | Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up | Missing | 41 Participants |
| Control | Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up | Abstinent | 40 Participants |
| Control | Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up | Non-Abstinent | 83 Participants |
| Control | Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up | Missing | 31 Participants |