Schizophrenia
Conditions
Keywords
Schizophrenia, Smoking, Tobacco, Motivation, Cessation Treatment
Brief summary
In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. The Specific Aims of the study are: 1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence. 2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed. 3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months 1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months. 2. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
Detailed description
Up to 80% of people with schizophrenia and schizoaffective disorders smoke - a rate that is four times the rate in the general population. Cessation treatments are effective, but these smokers don't use them. In order to provide an easy-to-use, cost-effective strategy to engage this group of smokers into effective treatments, we developed a single-session, web-based, motivational decision support system, Let's Talk About Smoking. The system incorporates features that insure high usability among those who can't use current websites due to cognitive impairments and low computer skills. It provides compelling content that engages users into evidence-based cessation treatments. In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. Our proposed study design will enable us to test whether this system, designed for those with cognitive impairments, is effective among people with a range of cognitive abilities. The Specific Aims of the study are: 1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence. 2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed. 3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months 1. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months. 2. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* 18-70 years old * DSM-IV-TR diagnosis psychotic disorder * in treatment at participating mental health center * current daily smoker * fluent in English * physically able to use computer * willing and able to give informed consent
Exclusion criteria
* past 2 weeks use of evidence based cessation treatment * psychiatric instability * current alcohol or drug dependence * pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects That Initiated Cessation Treatment | 6 months | Cessation treatment initiation and engagement will be collected from clinician attendance sheets in the medical record and medical record review for prescriptions. Medication use will be confirmed with self-report of taking medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Confirmed Abstinence | 6 months | Biologically confirmed abstinence: we will confirm 7-day point prevalence abstinence at 6 month assessments (self-reported abstinence without any smoking, not even a puff, for the past 7 days,) with expired carbon monoxide (reading ≤9). |
| Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence | 6 months | — |
Countries
United States
Participant flow
Pre-assignment details
After participating in an informed consent process, 184 subjects were assessed for eligibility. 11 were ineligible and 11 declined or were unable to proceed with the study for other reasons. 162 were randomized and proceeded to receive an intervention.
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Intervention Web-based motivational decision support system | 78 |
| Educational Intervention Computerized version of the National Cancer Institute (NCI) Educational Pamphlet
NCI Education | 84 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | moved | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| Age, Continuous | 47.62 years STANDARD_DEVIATION 11.29 | 44.32 years STANDARD_DEVIATION 11.18 | 45.91 years STANDARD_DEVIATION 11.32 |
| Brief Psychiatric Rating Scale | 41.79 units on a scale STANDARD_DEVIATION 11.95 | 40.38 units on a scale STANDARD_DEVIATION 10.32 | 41.06 units on a scale STANDARD_DEVIATION 11.11 |
| Cigarettes per day | 14.48 cigarettes STANDARD_DEVIATION 9.62 | 14.64 cigarettes STANDARD_DEVIATION 11.3 | 14.56 cigarettes STANDARD_DEVIATION 10.49 |
| Cognition battery Z Scores | -.029 units on a scale STANDARD_DEVIATION 0.68 | .016 units on a scale STANDARD_DEVIATION 0.7 | -.006 units on a scale STANDARD_DEVIATION 0.69 |
| Fagerstrom dependence score | 5.03 units on a scale STANDARD_DEVIATION 2.19 | 5.30 units on a scale STANDARD_DEVIATION 1.8 | 5.16 units on a scale STANDARD_DEVIATION 2 |
| Positive and Negative Affect Schedule - Negative | 12.04 units on a scale STANDARD_DEVIATION 9.09 | 12.06 units on a scale STANDARD_DEVIATION 9.45 | 12.05 units on a scale STANDARD_DEVIATION 9.25 |
| Positive and Negative Affect Schedule - Positive | 22.36 units on a scale STANDARD_DEVIATION 8.66 | 22.31 units on a scale STANDARD_DEVIATION 8.48 | 22.33 units on a scale STANDARD_DEVIATION 8.54 |
| Region of Enrollment United States | 78 participants | 84 participants | 162 participants |
| Sex: Female, Male Female | 29 Participants | 25 Participants | 54 Participants |
| Sex: Female, Male Male | 49 Participants | 59 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 78 | 1 / 84 |
| serious Total, serious adverse events | 1 / 78 | 0 / 84 |
Outcome results
Number of Subjects That Initiated Cessation Treatment
Cessation treatment initiation and engagement will be collected from clinician attendance sheets in the medical record and medical record review for prescriptions. Medication use will be confirmed with self-report of taking medication.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Let's Talk About Smoking | Number of Subjects That Initiated Cessation Treatment | 27 participants |
| National Cancer Institute (NCI) Computerized Education | Number of Subjects That Initiated Cessation Treatment | 36 participants |
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Let's Talk About Smoking | Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence | 13 Participants |
| National Cancer Institute (NCI) Computerized Education | Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence | 11 Participants |
Number of Subjects With Confirmed Abstinence
Biologically confirmed abstinence: we will confirm 7-day point prevalence abstinence at 6 month assessments (self-reported abstinence without any smoking, not even a puff, for the past 7 days,) with expired carbon monoxide (reading ≤9).
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Let's Talk About Smoking | Number of Subjects With Confirmed Abstinence | 1 participants |
| National Cancer Institute (NCI) Computerized Education | Number of Subjects With Confirmed Abstinence | 6 participants |