A Phase 4 interventional study of Cognitive / Motivational Individual Sessions and Attention Control Individual Sessions in Smoking, Nicotine Dependence and Mental Disorders, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-02-29.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
This study tests whether pre-cessation interventions known to be effective in the general population will increase acceptance of evidence-based treatment, engagement and compliance with that treatment and initial quitting success. One hundred and seventy two patients will be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to those diagnosed with persistent and serious mental illness. All participants will receive two group sessions (40 minutes each) modeled after "Kicking Butts", a group-based quitting preparation program used for the past four years in two Milwaukee CSP programs run by Wisconsin Community Services. Individuals will then be randomly assigned to the experimental and control conditions (n=86 each). Experimental subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each). Attention control subjects will also receive four individual sessions of the same duration. However their individual sessions' content will be a discussion of the personal relevance of the group material and will not include any of the preparatory interventions. Data will be collected via brief surveys taken pre-intervention, at the end of the last individual session, and three months later and from a database provided by the Wisconsin Tobacco Quit Line (WTQL).
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 270 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm of the project will address the following questions: After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group? After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Behavioral: Cognitive / Motivational Individual Sessions · Drug: Nicotine Patch · Behavioral: Group Curriculum
This arm of the project will address the following question: After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group? After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
Behavioral: Attention Control Individual Sessions · Behavioral: Group Curriculum
This arm of the project will address the following question: Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group? Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group? Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services.
Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking.
Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.
Everyone to be put into the experimental or active comparator group will attend 2 group meetings over two weeks each of which lasts 40 minutes. Experience with the Kicking Butts program indicates that this duration is well tolerated by this population. The content of these two group meetings is based on the Kicking Butts program. The Kicking Butts program was initially developed as a cessation intervention, but consistent with the literature about the need to prepare this population to make a quit attempt, has evolved to emphasize preparation for quitting. Topics addressed include the health consequences of smoking, reasons to quit and methods of quitting.
Acceptance of Wisconsin Tobacco Quit Line Services
The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.
Time frame: 4-6 weeks after study enrollment
| Milestone | Cognitive/Motivational Intervention Group | Attention Control Group | Motivated Smokers Comparison Group |
|---|---|---|---|
| Started | 118 | 104 | 48 |
| Completed | 88 | 58 | 25 |
| Not completed | 30 | 46 | 23 |
The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.
| participants | Cognitive/Motivational Intervention Group | Attention Control Group | Motivated Smokers Comparison Group |
|---|---|---|---|
| Acceptance of Wisconsin Tobacco Quit Line Services | 11 | 6 | 6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive/Motivational Intervention Group | — | 0/118 (0%) | 0/118 (0%) |
| Attention Control Group | — | 0/104 (0%) | 0/104 (0%) |
| Motivated Smokers Comparison Group | — | 0/48 (0%) | 0/48 (0%) |
| Age, Continuous(years) | Cognitive/Motivational Intervention Group | Attention Control Group | Motivated Smokers Comparison Group | Total |
|---|---|---|---|---|
| Mean | 43.8 ± 9.88 | 43.6 ± 10.05 | 45.0 ± 9.54 | 44.0 ± 9.87 |
| Sex: Female, Male(Participants) | Cognitive/Motivational Intervention Group | Attention Control Group | Motivated Smokers Comparison Group | Total |
|---|---|---|---|---|
| Female | 58 | 48 | 24 | 130 |
| Male | 60 | 56 | 24 | 140 |
| Region of Enrollment(participants) | Cognitive/Motivational Intervention Group | Attention Control Group | Motivated Smokers Comparison Group | Total |
|---|---|---|---|---|
| United States | 118 | 104 | 48 | 270 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison