Helping Those With Mental Illness Quit Smoking

January 29, 2016 updated by: University of Wisconsin, Madison

Preparing Those With Significant and Persistent Mental Illness to Quit Smoking

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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?
Behavioral: 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).
Drug: Nicotine Patch
Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.
Behavioral: Group 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.
Active Comparator: 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?
Behavioral: Group 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance of Wisconsin Tobacco Quit Line Services
Time Frame: 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.
4-6 weeks after study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Bruce Christiansen, PhD, University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0604

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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