Working Inside for Smoking Elimination (WISE)
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine the extent to which an Intentional Behavioral Intervention will increase tobacco quit rates post release among incarcerated men and women.
| Condition | Intervention |
|---|---|
|
Cigarette Smoking Tobacco Smoking |
Behavioral: Motivational Interviewing/CBT Other: CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sustaining Tobacco Abstinence After Incarceration |
- Smoking abstinence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Motivation Interviewing/CBT |
Behavioral: Motivational Interviewing/CBT
6 sessions of in jail MI/CBT counseling will be administered.
|
|
Active Comparator: Control
Receive a smoking cessation pamphlet and watch a series of six weekly 30-45 minutes general wellness videos.
|
Other: CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)
a series of six weekly 30-45 minutes general wellness videos
|
Detailed Description:
Quitting smoking reduces the risks of developing smoking related illnesses as well as the morbidity and mortality associated with these illnesses. In 2006 approximately 44.5 million American adults smoked an overall prevalence of 20.8%. The prevalence is much higher among incarcerated populations and approximately 80% of the women in RI smoked prior to incarceration. This proposal is designed to evaluate an intervention utilizing Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) to provide the skills necessary to maintain smoking abstinence after release. MI utilizes specific techniques for providing feedback on an individual's risk and self efficacy. CBT provides the skills necessary to maintain abstinence after release. The investigators plan to recruit 350 men and women from the Rhode Island Department of Corrections and randomize them to two interventions: an Intentional Behavioral Intervention (IBI) with 6 sessions of in jail MI/CBT and two post release booster sessions compared to CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL) group which will receive a smoking cessation pamphlet and watch a series of six weekly 30-45 minutes general wellness videos.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18 and older
- Daily smokers over the past 30 non-institutionalized days (prior to Incarceration)
- Expected place of residence after release within 15 miles of follow-up site
- Agree to participate in the study protocol and be available within one month post release
- Speak English
- Provides at least two pieces of locator information
- Scheduled to be released within eight weeks
Exclusion Criteria:
- Inability to give informed consent secondary to organic brain function, not having own legal guardianship, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that impair ability to participate in computerized assessment or counseling)
- Housed in a segregation unit
Contacts and Locations| Contact: Jennifer G Clarke, MD | 401-729-3400 | Jennifer_Clarke@mhri.org |
| Contact: Jennifer A Mello, MPH | 401-729-3573 | Jennifer_Mello@mhri.org |
| United States, Rhode Island | |
| Memorial Hospital of Rhode Island | Recruiting |
| Pawtucket, Rhode Island, United States, 02860 | |
| Contact: Jennifer G Clarke, MD 401-729-3400 Jennifer_Clarke@mhri.org | |
| Contact: Jennifer A Mello, MPH 401-729-3573 Jennifer_Mello@mhri.org | |
| Principal Investigator: Jennifer G Clarke, MD | |
| Principal Investigator: | Jennifer G Clarke, MD | Memorial Hospital of Rhode Island |
More Information
No publications provided by Memorial Hospital of Rhode Island
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jennifer G. Clarke, MD MPH, Memorial Hospital of Rhode Island |
| ClinicalTrials.gov Identifier: | NCT01122589 History of Changes |
| Other Study ID Numbers: | WISE 09-21, 1R01DA024093-01A2 |
| Study First Received: | May 12, 2010 |
| Last Updated: | September 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Hospital of Rhode Island:
|
Smoking Abstinence Smoking Cessation |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 21, 2013