Helping Those With Mental Illness Quit Smoking

Phase 4

Completed

• Conditions: Smoking; Nicotine Dependence; Mental Disorders
• Interventions: Behavioral: Attention Control Individual Sessions; Behavioral: Cognitive / Motivational Individual Sessions; Drug: Nicotine Patch; Behavioral: Group Curriculum

• Registration Number: NCT01783912
• Lead Sponsor: University of Wisconsin, Madison

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-12-21
• Results First Submitted QC: 2015-12-23
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Results First Posted: 2016-02-01
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cognitive/Motivational Intervention Group	Group Curriculum	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?
Attention Control Group	Attention Control Individual Sessions	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 Group	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?
Cognitive/Motivational Intervention Group	Cognitive / Motivational Individual Sessions	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 Intervention Group	Nicotine Patch	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?

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States