Trial Outcomes & Findings for Helping Those With Mental Illness Quit Smoking (NCT NCT01783912)
NCT ID: NCT01783912
Last Updated: 2016-02-29
Results Overview
The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
270 participants
Primary outcome timeframe
4-6 weeks after study enrollment
Results posted on
2016-02-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
118
|
104
|
48
|
|
Overall Study
COMPLETED
|
88
|
58
|
25
|
|
Overall Study
NOT COMPLETED
|
30
|
46
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Helping Those With Mental Illness Quit Smoking
Baseline characteristics by cohort
| Measure |
Cognitive/Motivational Intervention Group
n=118 Participants
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.
|
Attention Control Group
n=104 Participants
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.
|
Motivated Smokers Comparison Group
n=48 Participants
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.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 9.88 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 10.05 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 9.87 • n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
118 participants
n=5 Participants
|
104 participants
n=7 Participants
|
48 participants
n=5 Participants
|
270 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeks after study enrollmentThe primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.
Outcome measures
| Measure |
Cognitive/Motivational Intervention Group
n=118 Participants
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.
|
Attention Control Group
n=104 Participants
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.
|
Motivated Smokers Comparison Group
n=48 Participants
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.
|
|---|---|---|---|
|
Acceptance of Wisconsin Tobacco Quit Line Services
|
11 participants
|
6 participants
|
6 participants
|
Adverse Events
Cognitive/Motivational Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivated Smokers Comparison Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bruce Christiansen
Center for Tobacco Research and Intervention
Phone: 608-262-4087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place