Helping Those With Mental Illness Quit Smoking
Preparing Those With Significant and Persistent Mental Illness to Quit Smoking
1 other identifier
interventional
270
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 22, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
February 1, 2016
CompletedFebruary 29, 2016
January 1, 2016
1.5 years
January 22, 2013
December 21, 2015
January 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4-6 weeks after study enrollment
Study Arms (3)
Cognitive/Motivational Intervention Group
EXPERIMENTALThis 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?
Attention Control Group
ACTIVE COMPARATORThis 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?
Motivated Smokers Comparison Group
NO INTERVENTIONThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bruce Christiansen
- Organization
- Center for Tobacco Research and Intervention
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Christiansen, PhD
University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2013
First Posted
February 5, 2013
Study Start
December 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
February 29, 2016
Results First Posted
February 1, 2016
Record last verified: 2016-01