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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Abstinence Reinforcement Therapy (ART) |
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| Control | Other | Telephone Counseling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abstinence Reinforcement Therapy (ART) | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-month post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick S Calhoun, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27521811 | Result | Wilson SM, Hair LP, Hertzberg JS, Kirby AC, Olsen MK, Lindquist JH, Maciejewski ML, Beckham JC, Calhoun PS. Abstinence Reinforcement Therapy (ART) for rural veterans: Methodology for an mHealth smoking cessation intervention. Contemp Clin Trials. 2016 Sep;50:157-65. doi: 10.1016/j.cct.2016.08.008. Epub 2016 Aug 10. | |
| 27046670 | Result |
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Participants who did not complete a follow-up were not prohibited from participating in the remaining study follow-up periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Treatment Phase |
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| 3-Month Follow-up |
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| 6-Month Follow-up |
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| 12-Month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6-month post-treatment |
|
up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick Calhoun | Durham Veterans Affairs Medical Center | 919-286-0411 | 7970 | patrick.calhoun2@va.gov |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Telephone Counseling and NRT | Behavioral | Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT) |
|
|
| Dennis PA, Kimbrel NA, Dedert EA, Beckham JC, Dennis MF, Calhoun PS. Supplemental nicotine preloading for smoking cessation in posttraumatic stress disorder: Results from a randomized controlled trial. Addict Behav. 2016 Aug;59:24-9. doi: 10.1016/j.addbeh.2016.03.004. Epub 2016 Mar 11. |
| 28340108 | Result | Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339. |
| 28808856 | Result | Calhoun PS, Wilson SM, Hertzberg JS, Kirby AC, McDonald SD, Dennis PA, Bastian LA, Dedert EA; VA Mid-Atlantic MIRECC Workgroup; Beckham JC. Validation of Veterans Affairs Electronic Medical Record Smoking Data Among Iraq- and Afghanistan-Era Veterans. J Gen Intern Med. 2017 Nov;32(11):1228-1234. doi: 10.1007/s11606-017-4144-5. Epub 2017 Aug 14. |
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| 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) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Distance to nearest VA hospital or clinic (miles) | Distance from the participant's home to the nearest VA hospital or VA clinic (in miles). | Count of Participants | Participants |
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| Fagerstrom Test for Nicotine Dependence | Scores can range from 0-10; higher scores reflect a higher level of nicotine dependence. | Mean | Standard Deviation | units on a scale |
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| Self efficacy scale for quitting smoking in next 6 months | 1=not at all to 7=very confident | Mean | Standard Deviation | units on a scale |
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|
|
| 2 |
| 156 |
| 0 |
| 156 |
| 0 |
| 156 |
| EG001 | 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) | 0 | 154 | 0 | 154 | 0 | 154 |
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