An interventional study of Electronic Decision Support System in Mental Illness, Tobacco Smoking and Psychotic Disorders, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 3 sites in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2018-06-27.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Other
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 58 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
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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)
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
A computer program aimed to educate people about smoking cessation treatment.
Behavioral: Electronic Decision Support System
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.
Time frame: 14 week follow-up
Number of Participants With Biologically Confirmed Abstinence
Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide \<9 ppm
Time frame: 14 weeks
| Milestone | Electronic Decision Support System | Control Computer Program |
|---|---|---|
| Started | 30 | 28 |
| Completed | 27 | 23 |
| Not completed | 3 | 5 |
| Withdrew: Withdrawal by subject | 3 | 5 |
Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.
| Participants | Electronic Decision Support System | Control Computer Program |
|---|---|---|
| Number of Participants Who Utilized Smoking Cessation Treatment | 2 | 1 |
Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide \<9 ppm
| Participants | Electronic Decision Support System | Control Computer Program |
|---|---|---|
| Number of Participants With Biologically Confirmed Abstinence | 4 | 0 |
Collected over 14 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Electronic Decision Support System | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Control Computer Program | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Electronic Decision Support System | Control Computer Program | Total |
|---|---|---|---|
| Mean | 23.5 ± 3.9 | 25.0 ± 3.2 | 24.2 ± 3.4 |
| Sex: Female, Male(Participants) | Electronic Decision Support System | Control Computer Program | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 20 | 19 | 39 |
| Race/Ethnicity, Customized(Participants) | Electronic Decision Support System | Control Computer Program | Total |
|---|---|---|---|
| Caucasian | 17 | 16 | 33 |
| African American | 9 | 10 | 19 |
| Other race | 4 | 2 | 6 |
| Mean cigarettes per day(cigarettes) | Electronic Decision Support System | Control Computer Program | Total |
|---|---|---|---|
| Mean | 10.9 ± 8.6 | 13.9 ± 9.4 | 12.3 ± 9.0 |
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Dartmouth-Hitchcock Medical Center