Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness
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|ClinicalTrials.gov Identifier: NCT01779440|
Recruitment Status : Unknown
Verified August 2015 by Dartmouth-Hitchcock Medical Center.
Recruitment status was: Active, not recruiting
First Posted : January 30, 2013
Last Update Posted : August 19, 2015
Up to 77% of young people with severe mental illnesses smoke, a rate that is up to five times higher than the rate of daily smoking in other young adults. Contrary to popular belief, smoking tobacco does not provide any benefit for mental illness symptom control. People with severe mental illnesses (SMI: schizophrenia and severe mood disorders) are dying, on average, 25 years earlier than those without SMI. Much of this early mortality is due to higher rates of heart and lung diseases, cancers, strokes, and diabetes.
Cessation of smoking in these transition-age young adults can prevent cancer and increase life expectancy to that of non-smokers. Combination treatments are effective in this group and therefore key to improving outcomes, but few SMI smokers use them despite their interest in quitting. Motivational interventions for cessation increase interest in quitting, but public mental health clinicians do not deliver them, in part due to economic reasons. Thus cost effective methods to deliver motivational interventions to engage young smokers with SMI into treatment are needed.
To address this gap, we have developed an electronic decision support system (EDSS) for smoking cessation that is specifically tailored for smokers with SMI, who tend to have cognitive deficits and limited computer experience. Similar to EDSSs developed for other health problems, this EDSS provides information and motivational exercises within an easy-to-use, web-based computer program that can be used with minimal or no staff assistance. Initial piloting of the EDSS in middle-aged SMI smokers showed excellent usability and promising efficacy. Pilot-testing among young patients suggested that the EDSS increased motivation to quit smoking and provided direction to adapt the format and content of the EDSS for young SMI smokers.
The purpose of this proposal is to further develop the motivational decision support system and to test its ability to motivate young smokers with SMI to quit smoking with cessation treatment.
|Condition or disease||Intervention/treatment||Phase|
|Mental Illness Tobacco Smoking Psychotic Disorders||Behavioral: Electronic Decision Support System||Not Applicable|
The research will take place over 2 years at the Long Island Zucker Hillside Hospital system. In Year 1, we will adapt our electronic decision support system, a web-based motivational tool, for young smokers with severe mental illness. We will first identify beliefs of young smokers with severe mental illness that impede use of smoking cessation treatments. Then, the decision support system will be revised to change these beliefs, field-tested for usability, and improved as needed. In Year 2, we will conduct a randomized control trial of the newly revised version of the system among 60 young smokers with severe psychotic disorders.
In the controlled trial, participants will be assessed at baseline for mental health symptoms and smoking behavior and history, and then randomized to use the system or a computerized public health pamphlet (control condition) within two weeks. Participants will be assessed again at 14-week follow-up for clinician-confirmed initiation of smoking cessation treatment (main outcome), beliefs, and smoking characteristics. Analyses will assess whether use of the decision support system results in greater initiation of cessation treatment (main outcome), and changes in beliefs about treatment, than use of the control intervention.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||December 2015|
Electronic Decision Support System
The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment.
Behavioral: Electronic Decision Support System
Placebo Comparator: Control Computer Program
A computer program aimed to educate people about smoking cessation treatment.
- Change in Smoking Cessation Treatment measured by the behavioral Checklist delivered at baseline and 14 weeks [ Time Frame: Baseline and 14 weeks ]Assesses through self-report and clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779440
|United States, New Hampshire|
|Mental Health Center of Greater Manchester|
|Manchester, New Hampshire, United States, 03103|
|Greater Nashua Mental Health Center|
|Nashua, New Hampshire, United States, 03060|
|United States, New York|
|Glen Oaks, New York, United States, 11004|
|Principal Investigator:||Mary F. Brunette, MD||Dartmouth College|