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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA158863-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic Decision Support System | Other | 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. |
|
| Control Computer Program | Placebo Comparator | A computer program aimed to educate people about smoking cessation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Decision Support System | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Utilized Smoking Cessation Treatment | Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment. | 14 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biologically Confirmed Abstinence | Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm | 14 weeks |
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Inclusion Criteria:
English-speaking; non-pregnant/nursing; daily smokers; age 18-30; psychiatrically stable; in treatment in the Zucker Hillside Hospital system; diagnosed with SMI (schizophrenia, schizoaffective disorder, or mood disorder with psychotic features from medical chart); willing and able to give informed consent.
Exclusion Criteria:
(Phase 4 only): current (within the past month) use of evidence-based smoking cessation treatment (indicating the subject is already motivated), psychiatric instability (Modified Colorado Symptom Index score >45), current untreated substance use disorder (SUD)
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| Name | Affiliation | Role |
|---|---|---|
| Mary F. Brunette, MD | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Center of Greater Manchester | Manchester | New Hampshire | 03103 | United States | ||
| Greater Nashua Mental Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29881770 | Background | Brunette MF, Feiron JC, Aschbrenner K, Colctti D, Devitt T, Greene MA, Harrington A, MoHugo GC, Pratt S, Robinson D, Williams J, Xie H. Characteristics and Predictors of Intention to use Cessation Treatment among Smokers with Schizophrenia: Young Adults Compared to Older Adults. J Subst Abus Alcohol. 2017;5(1):1055. Epub 2017 Mar 23. | |
| 29059417 | Result | Brunette MF, Ferron JC, Robinson D, Coletti D, Geiger P, Devitt T, Klodnick V, Gottlieb J, Xie H, Greene MA, Ziedonis D, Drake RE, McHugo GJ. Brief Web-Based Interventions for Young Adult Smokers With Severe Mental Illnesses: A Randomized, Controlled Pilot Study. Nicotine Tob Res. 2018 Sep 4;20(10):1206-1214. doi: 10.1093/ntr/ntx190. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Electronic Decision Support System |
| FG001 | Control Computer Program | A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Electronic Decision Support System |
| BG001 | Control Computer Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Utilized Smoking Cessation Treatment | Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment. | Posted | Count of Participants | Participants | 14 week follow-up |
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Electronic Decision Support System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary F. Brunette, MD | Dartmouth-Hitchcock | 603-229-5419 | Mary.F.Brunette@hitchcock.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2015 | May 7, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2015 | May 7, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| Nashua |
| New Hampshire |
| 03060 |
| United States |
| Zucker-Hillside Hospital | Glen Oaks | New York | 11004 | United States |
A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Mean cigarettes per day | Mean | Standard Deviation | cigarettes |
|
|
|
|
| Secondary | Number of Participants With Biologically Confirmed Abstinence | Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm | Participants who attended the follow-up assessment | Posted | Count of Participants | Participants | 14 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control Computer Program | A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System | 0 | 28 | 0 | 28 | 0 | 28 |
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