Viewing Study NCT00690131



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Study NCT ID: NCT00690131
Status: COMPLETED
Last Update Posted: 2020-04-06
First Post: 2008-06-02

Brief Title: An Integrated Approach to Smoking Cessation in Severe Mental Illness SMI
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: An Integrated Approach to Smoking Cessation in SMI
Status: COMPLETED
Status Verified Date: 2020-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This 3-year study will involve the design and small-scale clinical trial of a behavioral treatment program for smoking cessation in people with severe mental illness called Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness or BTSCS in two psychosocial rehabilitation programs PRPs in Baltimore Our aims are 1 Develop intervention materials and examine feasibility acceptability and safety 2 Measure the effects of the intervention at post-treatment and 3-month follow-up on rates of smoking cessation number of quit attempts rates of smoking reduction and intentionmotivation to quit smoking
Detailed Description: Smoking is the leading cause of preventable death in the United States contributing to increased rates of lung cancer and heart disease and adding complications to other health problems Over 70 of people with serious mental illnesses SMI smoke a rate that is double that of the general population and remains high despite decreases in overall smoking rates Smoking contributes to elevated morbidity and mortality in SMI has other life-threatening consequences and increases health care costs in SMI While treating smoking is a critical step in improving the health of people with SMI there are features of SMI that make treatment difficult low motivation to quit symptoms barriers to attendance cognitive deficits poor social functioning Stop-smoking groups have had limited success in achieving smoking cessation SC likely because they have not been tailored for people with SMI SC for SMI must address the deficits and barriers to change found in this population and must be integrated with mental health services

This study will involve the design and small-scale clinical trial of a behavioral treatment program for SC in people with SMI called Behavioral Treatment for Smoking Cessation in Serious and Persistent Mental Illness BTSCS in two psychosocial rehabilitation programs PRPs in Baltimore

We will first provide basic education for PRP staff regarding smoking cessation in SMI to promote smoking cessation as a goal of mental health treatment We will then pilot test BTSCS with components that include 1 A behavioral group emphasizing motivational enhancement skills training education and relapse prevention 2 Contingency management with financial incentives to reinforce reductions in smoking 3 Supported use of Bupropion or nicotine replacement therapy that is integrated with clients psychiatric care in participants who are interested and 4 Smoking cessation care coordination to increase treatment engagement and retention Our primary aims are 1 Develop intervention materials and examine feasibility acceptability and safety 2 Measure the effects of the intervention at post-treatment and 3-month follow-up on rates of smoking cessation number of quit attempts rates of smoking reduction and intentionmotivation to quit smoking

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R34MH080814-01A1 NIH None httpsreporternihgovquickSearch1R34MH080814-01A1