Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
Phase 4
Completed
- Conditions
- MotivationSmoking CessationSmoking
- Interventions
- Other: No TreatmentBehavioral: Behavioral Reduction CounselingBehavioral: 5Rs Motivation CounselingBehavioral: Behavioral Activation Counseling
- Registration Number
- NCT02354872
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package. This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4) Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling. These components have strong theoretical and empirical support, but their relative, additive, and interactive effects are unknown.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 577
Inclusion Criteria
- age >=18 years; smoking >4 cigarettes/day for the previous 6 months; able to read, write, and speak English; have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts; and if currently using NRT, agreeing to use only study medication for the duration of the study. We will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses); not currently attempting to quit smoking; not intending to quit smoking (defined as no plans to quit in the next month); and planning to remain in the intervention catchment area for at least 12 months.
Exclusion Criteria
- currently taking bupropion or varenicline; medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days; diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years; and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Mini-Lozenge, BR, No 5Rs, BA Nicotine Mini-Lozenge 3; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, No 5Rs, BA Mini-Lozenge, BR, No 5Rs, No BA Nicotine Mini-Lozenge 4; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, No 5Rs, No BA Mini-Lozenge, No BR, 5Rs, BA Nicotine Mini-Lozenge 5; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, No BR, 5Rs, BA Mini-Lozenge, No BR, 5Rs, No BA Nicotine Mini-Lozenge 6; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, No BR, 5Rs, No BA Mini-Lozenge, No BR, No 5Rs, BA Nicotine Mini-Lozenge 7; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, No BR, No 5Rs, BA Mini-Lozenge, No BR, No 5Rs, No BA Nicotine Mini-Lozenge 8; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, No BR, No 5Rs, No BA Mini-Lozenge, BR, 5Rs, BA Nicotine Mini-Lozenge 1; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, 5Rs, BA Mini-Lozenge, BR, 5Rs, BA Behavioral Reduction Counseling 1; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, 5Rs, BA Mini-Lozenge, BR, 5Rs, No BA 5Rs Motivation Counseling 2; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, 5Rs, No BA Mini-Lozenge, BR, 5Rs, BA Behavioral Activation Counseling 1; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, 5Rs, BA Mini-Lozenge, BR, 5Rs, No BA Nicotine Mini-Lozenge 2; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, 5Rs, No BA Mini-Lozenge, BR, No 5Rs, BA Behavioral Reduction Counseling 3; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, No 5Rs, BA Mini-Lozenge, BR, No 5Rs, No BA Behavioral Reduction Counseling 4; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, No 5Rs, No BA Mini-Lozenge, BR, 5Rs, BA 5Rs Motivation Counseling 1; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, 5Rs, BA Mini-Lozenge, No BR, 5Rs, No BA 5Rs Motivation Counseling 6; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, No BR, 5Rs, No BA Mini-Lozenge, BR, 5Rs, No BA Behavioral Reduction Counseling 2; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, 5Rs, No BA No Mini-Lozenge, BR, 5Rs, BA Behavioral Activation Counseling 9; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, BR, 5Rs, BA No Mini-Lozenge, No BR, 5Rs, No BA 5Rs Motivation Counseling 14; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, No BR, 5Rs, No BA Mini-Lozenge, BR, No 5Rs, BA Behavioral Activation Counseling 3; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, BR, No 5Rs, BA No Mini-Lozenge, BR, 5Rs, No BA 5Rs Motivation Counseling 10; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, BR, 5Rs, No BA No Mini-Lozenge, BR, No 5Rs, BA Behavioral Reduction Counseling 11; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, BR, No 5Rs, BA No Mini-Lozenge, No BR, 5Rs, BA 5Rs Motivation Counseling 13; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, No BR, 5Rs, BA Mini-Lozenge, No BR, 5Rs, BA 5Rs Motivation Counseling 5; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, No BR, 5Rs, BA No Mini-Lozenge, BR, 5Rs, BA Behavioral Reduction Counseling 9; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, BR, 5Rs, BA No Mini-Lozenge, BR, 5Rs, BA 5Rs Motivation Counseling 9; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, BR, 5Rs, BA No Mini-Lozenge, BR, 5Rs, No BA Behavioral Reduction Counseling 10; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, BR, 5Rs, No BA Mini-Lozenge, No BR, 5Rs, BA Behavioral Activation Counseling 5; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, No BR, 5Rs, BA Mini-Lozenge, No BR, No 5Rs, BA Behavioral Activation Counseling 7; This arm of the project will address the following question: How effective is the following intervention? Mini-Lozenge, No BR, No 5Rs, BA No Mini-Lozenge, No BR, 5Rs, BA Behavioral Activation Counseling 13; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, No BR, 5Rs, BA No Mini-Lozenge, BR, No 5Rs, BA Behavioral Activation Counseling 11; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, BR, No 5Rs, BA No Mini-Lozenge, BR, No 5Rs, No BA Behavioral Reduction Counseling 12; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, BR, No 5Rs, No BA No Mini-Lozenge, No BR, No 5Rs, No BA No Treatment 16; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, No BR, No 5Rs, No BA No Mini-Lozenge, No BR, No 5Rs, BA Behavioral Activation Counseling 15; This arm of the project will address the following question: How effective is the following intervention? No Mini-Lozenge, No BR, No 5Rs, BA
- Primary Outcome Measures
Name Time Method 7-Day Point-Prevalence Abstinence 12 months Participants who self-report no smoking for the past 7 days at the assessment endpoint (12 month follow-up) will be considered to meet criteria for 7-Day Point-Prevalence Abstinence. Participants who who report any smoking in the past 7 days (at the 12 month follow-up) will be considered to be relapsed (smoking).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States