Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
17 september 2020 bijgewerkt door: University of Wisconsin, Madison
Optimized Chronic Care for Smokers: A Comparative Effectiveness Approach; Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
577
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Wisconsin
-
Madison, Wisconsin, Verenigde Staten, 53711-2027
- University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Mini-Lozenge, BR, 5Rs, BA
1; This arm of the project will address the following question: How effective is the following intervention?
Mini-Lozenge, BR, 5Rs, BA
|
If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges.
Mini-Lozenges will be given at the initial visit and over the course of the whole study.
Participants will be instructed to use 9 pieces daily for the 12 months.
We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions.
Sessions are front-loaded to enhance acquisition of new behaviors.
BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time.
BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control.
The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals.
The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period.
Participants in the "on" condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation.
The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis.
The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions.
The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions.
This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction.
Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking.
The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
|
|
Experimenteel: Mini-Lozenge, BR, 5Rs, No BA
2; This arm of the project will address the following question: How effective is the following intervention?
Mini-Lozenge, BR, 5Rs, No BA
|
If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges.
Mini-Lozenges will be given at the initial visit and over the course of the whole study.
Participants will be instructed to use 9 pieces daily for the 12 months.
We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions.
Sessions are front-loaded to enhance acquisition of new behaviors.
BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time.
BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control.
The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals.
The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period.
Participants in the "on" condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation.
The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis.
The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions.
|
|
Experimenteel: Mini-Lozenge, BR, No 5Rs, BA
3; This arm of the project will address the following question: How effective is the following intervention?
Mini-Lozenge, BR, No 5Rs, BA
|
If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges.
Mini-Lozenges will be given at the initial visit and over the course of the whole study.
Participants will be instructed to use 9 pieces daily for the 12 months.
We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions.
Sessions are front-loaded to enhance acquisition of new behaviors.
BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time.
BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control.
The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals.
The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions.
This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction.
Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking.
The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
|
|
Experimenteel: Mini-Lozenge, BR, No 5Rs, No BA
4; This arm of the project will address the following question: How effective is the following intervention?
Mini-Lozenge, BR, No 5Rs, No BA
|
If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges.
Mini-Lozenges will be given at the initial visit and over the course of the whole study.
Participants will be instructed to use 9 pieces daily for the 12 months.
We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions.
Sessions are front-loaded to enhance acquisition of new behaviors.
BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time.
BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control.
The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals.
The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
|
|
Experimenteel: Mini-Lozenge, No BR, 5Rs, BA
5; This arm of the project will address the following question: How effective is the following intervention?
Mini-Lozenge, No BR, 5Rs, BA
|
If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges.
Mini-Lozenges will be given at the initial visit and over the course of the whole study.
Participants will be instructed to use 9 pieces daily for the 12 months.
The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period.
Participants in the "on" condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation.
The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis.
The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions.
The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions.
This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction.
Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking.
The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
|
|
Experimenteel: Mini-Lozenge, No BR, 5Rs, No BA
6; This arm of the project will address the following question: How effective is the following intervention?
Mini-Lozenge, No BR, 5Rs, No BA
|
If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges.
Mini-Lozenges will be given at the initial visit and over the course of the whole study.
Participants will be instructed to use 9 pieces daily for the 12 months.
The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period.
Participants in the "on" condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation.
The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis.
The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions.
|
|
Experimenteel: Mini-Lozenge, No BR, No 5Rs, BA
7; This arm of the project will address the following question: How effective is the following intervention?
Mini-Lozenge, No BR, No 5Rs, BA
|
If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges.
Mini-Lozenges will be given at the initial visit and over the course of the whole study.
Participants will be instructed to use 9 pieces daily for the 12 months.
The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions.
This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction.
Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking.
The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
|
|
Experimenteel: Mini-Lozenge, No BR, No 5Rs, No BA
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
|
If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges.
Mini-Lozenges will be given at the initial visit and over the course of the whole study.
Participants will be instructed to use 9 pieces daily for the 12 months.
|
|
Experimenteel: No Mini-Lozenge, BR, 5Rs, BA
9; This arm of the project will address the following question: How effective is the following intervention?
No Mini-Lozenge, BR, 5Rs, BA
|
We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions.
Sessions are front-loaded to enhance acquisition of new behaviors.
BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time.
BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control.
The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals.
The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period.
Participants in the "on" condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation.
The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis.
The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions.
The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions.
This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction.
Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking.
The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
|
|
Experimenteel: No Mini-Lozenge, BR, 5Rs, No BA
10; This arm of the project will address the following question: How effective is the following intervention?
No Mini-Lozenge, BR, 5Rs, No BA
|
We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions.
Sessions are front-loaded to enhance acquisition of new behaviors.
BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time.
BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control.
The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals.
The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period.
Participants in the "on" condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation.
The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis.
The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions.
|
|
Experimenteel: No Mini-Lozenge, BR, No 5Rs, BA
11; This arm of the project will address the following question: How effective is the following intervention?
No Mini-Lozenge, BR, No 5Rs, BA
|
We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions.
Sessions are front-loaded to enhance acquisition of new behaviors.
BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time.
BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control.
The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals.
The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions.
This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction.
Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking.
The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
|
|
Experimenteel: No Mini-Lozenge, BR, No 5Rs, No BA
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
|
We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions.
Sessions are front-loaded to enhance acquisition of new behaviors.
BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time.
BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control.
The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals.
The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
|
|
Experimenteel: No Mini-Lozenge, No BR, 5Rs, BA
13; This arm of the project will address the following question: How effective is the following intervention?
No Mini-Lozenge, No BR, 5Rs, BA
|
The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period.
Participants in the "on" condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation.
The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis.
The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions.
The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions.
This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction.
Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking.
The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
|
|
Experimenteel: No Mini-Lozenge, No BR, 5Rs, No BA
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
|
The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period.
Participants in the "on" condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation.
The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis.
The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions.
|
|
Experimenteel: No Mini-Lozenge, No BR, No 5Rs, BA
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
|
The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions.
This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction.
Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking.
The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
|
|
Experimenteel: No Mini-Lozenge, No BR, No 5Rs, No BA
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
|
Geen behandeling
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
7-Day Point-Prevalence Abstinence
Tijdsspanne: 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).
|
12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Michael C Fiore, MD, MPH, MBA, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
- Studie directeur: Jessica Cook, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
- Hoofdonderzoeker: Robin Mermelstein, PhD, Institute for Health Research and Policy, University of Illinois at Chicago
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2015
Primaire voltooiing (Werkelijk)
19 maart 2019
Studie voltooiing (Werkelijk)
19 maart 2019
Studieregistratiedata
Eerst ingediend
22 januari 2015
Eerst ingediend dat voldeed aan de QC-criteria
29 januari 2015
Eerst geplaatst (Schatting)
3 februari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 september 2020
Laatste update ingediend die voldeed aan QC-criteria
17 september 2020
Laatst geverifieerd
1 september 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2014-1041Motivation
- A534252 (Andere identificatie: UW Madison)
- CTRI (Andere identificatie: UW Madison)
- SMPH\MEDICINE\TOBACCO RE (Andere identificatie: UW Madison)
- 1P01CA180945-01 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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