Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01723163
• Collaborator: (none)
• Enrollment: 310
• Location: 1
• Arms: 2
• Actual Duration (Months): 45.3
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Veteran; Smoking Cessation	Behavioral: Abstinence Reinforcement Therapy (ART); Behavioral: Telephone Counseling and NRT	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 310 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
• Actual Study Start Date: Nov 21, 2013
• Actual Primary Completion Date: Dec 15, 2016
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Abstinence Reinforcement Therapy (ART)	Behavioral: 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); Other Names: Intervention
Other: Control Telephone Counseling	Behavioral: 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); Other Names: Control

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Patrick S Calhoun, PhD, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01723163
• Other Study ID Numbers: IIR 12-365
• First Posted: Nov 7, 2012
• Last Update Posted: Mar 1, 2019
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by VA Office of Research and Development: veteran; smoking cessation

Study Results

Participant Flow

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

Arm/Group Title	Intervention	Control
Arm/Group Description	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)	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)
Period Title: Baseline
STARTED	156	154
COMPLETED	156	154
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	156	154
COMPLETED	137	147
NOT COMPLETED	19	7
Period Title: Baseline
STARTED	137	147
COMPLETED	124	128
NOT COMPLETED	13	19
Period Title: Baseline
STARTED	136	147
COMPLETED	118	132
NOT COMPLETED	18	15
Period Title: Baseline
STARTED	135	147
COMPLETED	111	119
NOT COMPLETED	24	28

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	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)	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)	Total of all reporting groups
Overall Participants	156	154	310
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (11)	56 (11)	57 (11)
Sex: Female, Male (Count of Participants)
Female	17 10.9%	17 11%	34 11%
Male	139 89.1%	137 89%	276 89%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 1.3%	2 1.3%	4 1.3%
Not Hispanic or Latino	153 98.1%	152 98.7%	305 98.4%
Unknown or Not Reported	1 0.6%	0 0%	1 0.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.3%	2 1.3%	4 1.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	85 54.5%	90 58.4%	175 56.5%
White	61 39.1%	56 36.4%	117 37.7%
More than one race	8 5.1%	6 3.9%	14 4.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Education (Count of Participants)
More than High School	101 64.7%	103 66.9%	204 65.8%
High School or less	55 35.3%	51 33.1%	106 34.2%
Distance to nearest VA hospital or clinic (miles) (Count of Participants)
0-20 Miles	56 35.9%	53 34.4%	109 35.2%
21-40 Miles	49 31.4%	66 42.9%	115 37.1%
41-60 Miles	35 22.4%	21 13.6%	56 18.1%
61-80 Miles	9 5.8%	6 3.9%	15 4.8%
81-100 Miles	5 3.2%	5 3.2%	10 3.2%
101 Miles or more	2 1.3%	3 1.9%	5 1.6%
Fagerstrom Test for Nicotine Dependence (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4 (2)	4 (2)	4 (2)
Self efficacy scale for quitting smoking in next 6 months (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6 (1)	6 (1)	6 (1)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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)	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)
Measure Participants	156	154
Abstinent	38 24.4%	40 26%
Non-Abstinent	77 49.4%	83 53.9%
Missing	41 26.3%	31 20.1%

Adverse Events

Time Frame	up to 12 months
Arm/Group Title	Intervention		Control
Arm/Group Description	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)		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)
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/156 (1.3%)		0/154 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/154 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/154 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.