Nicotine Dependence, Schizophrenia, Severe Mental Illness, Tobacco Use Disorder
Conditions
Keywords
schizophrenia, severe mental illness, nicotine, smoking, motivation, electronic decision support system, motivational interviewing
Brief summary
This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.
Detailed description
Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood disorders) smoke cigarettes, and most suffer related health consequences. Although combined treatment with medication and psychosocial therapy can help people with SMI to quit smoking, it is rarely used. Motivational interventions can enhance the use of combined treatment, but motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and Thresholds investigators have developed an easy-to-use, web-based electronic decision support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has demonstrated excellent usability and increased engagement in smoking cessation treatments. One critical issue is the use of personalized health feedback. Motivational interventions for smoking cessation for smokers with SMI, including our EDSS, have included personal feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to implement, and largely unavailable in public mental health and primary care clinics. Further, research on use of carbon monoxide monitoring in the general population is equivocal. Another motivational strategy to personalize the negative health effects of smoking is a health checklist with feedback. Health checklists have been shown to be effective, are easy to use, have no expense, but have not been assessed separately from carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the health checklist compared to feedback from the carbon monoxide monitor is an essential next step in the development of this tool. Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist feedback alone. Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist feedback leads to higher rates of the distal outcomes, days of smoking abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.
Interventions
Web-based electronic decision support system with CO feedback and health-checklist
Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)
Sponsors
Study design
Eligibility
Inclusion criteria
* adult age 18-75 * in treatment for severe mental illness, * current smoker, * physically able to use a computer
Exclusion criteria
* Using smoking cessation treatment in past month, * substance dependence with current use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of Smoking Cessation Treatment | 2 months | Started smoking cessation treatment |
Secondary
| Measure | Time frame |
|---|---|
| Days of Nicotine Abstinence | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EDSS With CO Monitor Feedback Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist | 58 |
| EDSS Without CO Monitor Feedback Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone | 66 |
| Total | 124 |
Baseline characteristics
| Characteristic | EDSS With CO Monitor Feedback | EDSS Without CO Monitor Feedback | Total |
|---|---|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 9.3 | 46.3 years STANDARD_DEVIATION 10.8 | 46.5 years STANDARD_DEVIATION 10.1 |
| Cigarettes smoked per day | 15.0 Cigarettes STANDARD_DEVIATION 11.8 | 15.1 Cigarettes STANDARD_DEVIATION 10.8 | 15.0 Cigarettes STANDARD_DEVIATION 11.2 |
| Race/Ethnicity, Customized African American | 30 Participants | 30 Participants | 60 Participants |
| Race/Ethnicity, Customized Caucasian | 26 Participants | 16 Participants | 42 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Female | 14 Participants | 21 Participants | 35 Participants |
| Sex: Female, Male Male | 44 Participants | 45 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 66 |
| serious Total, serious adverse events | 0 / 58 | 0 / 66 |
Outcome results
Initiation of Smoking Cessation Treatment
Started smoking cessation treatment
Time frame: 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EDSS With CO Monitor Feedback | Initiation of Smoking Cessation Treatment | 14 participants |
| EDSS Without CO Monitor Feedback | Initiation of Smoking Cessation Treatment | 24 participants |
Days of Nicotine Abstinence
Time frame: 6 months