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)
310
Enrollment
1
Location
2
Arms
45.3
Actual Duration (Months)
6.8
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Durham VA Medical Center, Durham, NCDurhamNorth CarolinaUnited States27705

    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

    Study Results

    Participant Flow

    Recruitment DetailsParticipants who did not complete a follow-up were not prohibited from participating in the remaining study follow-up periods.
    Pre-assignment Detail
    Arm/Group TitleInterventionControl
    Arm/Group DescriptionAbstinence 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
    STARTED156154
    COMPLETED156154
    NOT COMPLETED00
    Period Title: Baseline
    STARTED156154
    COMPLETED137147
    NOT COMPLETED197
    Period Title: Baseline
    STARTED137147
    COMPLETED124128
    NOT COMPLETED1319
    Period Title: Baseline
    STARTED136147
    COMPLETED118132
    NOT COMPLETED1815
    Period Title: Baseline
    STARTED135147
    COMPLETED111119
    NOT COMPLETED2428

    Baseline Characteristics

    Arm/Group TitleInterventionControlTotal
    Arm/Group DescriptionAbstinence 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 Participants156154310
    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
    TitleNumber of Participants With Abstinence or Non-Abstinence at 6-month Follow-up
    DescriptionNon-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 Frame6-month post-treatment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleInterventionControl
    Arm/Group DescriptionAbstinence 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 Participants156154
    Abstinent
    38
    24.4%
    40
    26%
    Non-Abstinent
    77
    49.4%
    83
    53.9%
    Missing
    41
    26.3%
    31
    20.1%

    Adverse Events

    Time Frameup to 12 months
    Adverse Event Reporting Description
    Arm/Group TitleInterventionControl
    Arm/Group DescriptionAbstinence 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
    InterventionControl
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/156 (1.3%) 0/154 (0%)
    Serious Adverse Events
    InterventionControl
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/156 (0%) 0/154 (0%)
    Other (Not Including Serious) Adverse Events
    InterventionControl
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/156 (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.

    Results Point of Contact

    Name/TitleDr. Patrick Calhoun
    OrganizationDurham Veterans Affairs Medical Center
    Phone919-286-0411 ext 7970
    Emailpatrick.calhoun2@va.gov
    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