Mental Disorders, Nicotine Dependence, Smoking
Conditions
Keywords
Smoking, Nicotine Dependence, Mental Disorders
Brief summary
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).
Interventions
BEHAVIORALCognitive / Motivational Individual Sessions
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).
BEHAVIORALAttention Control Individual Sessions
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.
DRUGNicotine Patch
Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.
BEHAVIORALGroup Curriculum
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* current smoker (smoking daily or smoking at least 10 cigarettes per week) (use of other tobacco products permitted such as chew and snuz in addition to smoking) * not willing to make a quit attempt * willingness to use the nicotine patch * plans to remain in the area for the next five four months.
Exclusion criteria
* current use of any cessation medicine (nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray, bupropion, Wellbutrin, Zyban,Chantix or varenicline) * previous serious skin reaction or other allergic reaction to using the nicotine patch * stroke, heart attack or abnormal electrocardiogram in past four weeks * pregnancy, plans to get pregnant or nursing * exclusive use of other tobacco products (non-smoker tobacco user) * having a court-ordered guardian, or an activated power of attorney for health or observation by researchers during the consent procedure that suggests diminished decision making capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of Wisconsin Tobacco Quit Line Services | 4-6 weeks after study enrollment | The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive/Motivational Intervention Group 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?
Cognitive / Motivational Individual Sessions: 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).
Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks. | 118 |
| Attention Control Group 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?
Attention Control Individual Sessions: 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. | 104 |
| Motivated Smokers Comparison Group 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. | 48 |
| Total | 270 |
Baseline characteristics
| Characteristic | Cognitive/Motivational Intervention Group | Attention Control Group | Motivated Smokers Comparison Group | Total |
|---|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 9.88 | 43.6 years STANDARD_DEVIATION 10.05 | 45.0 years STANDARD_DEVIATION 9.54 | 44.0 years STANDARD_DEVIATION 9.87 |
| Region of Enrollment United States | 118 participants | 104 participants | 48 participants | 270 participants |
| Sex: Female, Male Female | 58 Participants | 48 Participants | 24 Participants | 130 Participants |
| Sex: Female, Male Male | 60 Participants | 56 Participants | 24 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 118 | 0 / 104 | 0 / 48 |
| serious Total, serious adverse events | 0 / 118 | 0 / 104 | 0 / 48 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cognitive/Motivational Intervention Group | Acceptance of Wisconsin Tobacco Quit Line Services | 11 participants |
| Attention Control Group | Acceptance of Wisconsin Tobacco Quit Line Services | 6 participants |
| Motivated Smokers Comparison Group | Acceptance of Wisconsin Tobacco Quit Line Services | 6 participants |