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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA168778 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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.
To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
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:
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.
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.
To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral intervention | Experimental | Web-based motivational decision support system |
|
| Educational intervention | Active Comparator | Computerized version of the National Cancer Institute (NCI) Educational Pamphlet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based motivational decision support system | Behavioral |
| ||
| NCI Education |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary F. Burnette, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thresholds | Chicago | Illinois | 60613 | United States | ||
| University of Massachusetts |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32039811 | Derived | Brunette MF, Ferron JC, McGurk SR, Williams JM, Harrington A, Devitt T, Xie H. Brief, Web-Based Interventions to Motivate Smokers With Schizophrenia: Randomized Trial. JMIR Ment Health. 2020 Feb 8;7(2):e16524. doi: 10.2196/16524. |
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De-identified research data files will be made available to all researchers in both the public and private sectors for potential statistical analyses or re-analyses in accordance with the NIH data Sharing Policy: http://grants.nih.gov/grants/policy/data sharing. Data will be available 2 years after data collection is completed, or after primary papers have been accepted for publication. Data will only be transferred to other researchers under a signed data sharing agreement.
Materials and research data files will be made available, upon request, from the PI. These requests can be made via email (mary.f.brunette@dartmouth.edu).
Data will be available for sharing after we complete our analyses, estimated to be in January 2020.
Investigators wishing to access data will submit a request with an analysis plan, data management plan and data safety plan to the PI. A signed data sharing agreement will be developed prior to release of the data.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Let's Talk About Smoking | These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior [98], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) [140, 141]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment [142-144], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment. |
| FG001 | National Cancer Institute (NCI) Computerized Education | The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition [162] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Intervention | Web-based motivational decision support system |
| BG001 | Educational Intervention | Computerized version of the National Cancer Institute (NCI) Educational Pamphlet NCI Education |
| 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 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. | Posted | Number | participants | 6 months |
|
6 months
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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 | Behavioral Intervention | These participants were randomized to use the Let's Talk About Smoking website. This web-based intervention (Let's Talk About Smoking) is designed to increase motivation to quit smoking by using evidence-based treatment. Based on the Theory of Planned Behavior [98], the decision support system addresses beliefs that are barriers to cessation and introduces new beliefs that facilitate use of cessation treatment. It uses messages with both gain and loss frames (benefits of use, costs of not using treatment) [140, 141]. It also provides facts with simple text and pictures about risks and benefits for each cessation treatment [142-144], encouraging users to make a choice based on information about treatment options. The system aims to change beliefs and attitudes related to cessation and cessation treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary F. Brunette | Dartmouth-Hitchcock | 603-229-5419 | mary.f.brunette@hitchcock.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Behavioral |
|
| 6 months |
| Worcester |
| Massachusetts |
| 01605 |
| United States |
| Rutgers-UNDMJ | New Brunswick | New Jersey | 08901 | United States |
| Lost to Follow-up |
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| Death |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Brief Psychiatric Rating Scale | A structured assessment of psychopathology severity using structured interview, observation, and record review. Scores may range from 7 to 126. | Mean | Standard Deviation | units on a scale |
|
| Positive and Negative Affect Schedule - Positive | Self report measure of positive affect. Scores range from 10 (low positive affect) to 50 (high positive affect). | Mean | Standard Deviation | units on a scale |
|
| Positive and Negative Affect Schedule - Negative | 10 Item self report measure of negative affect. Scores may range from 10 (low negative affect) to 50 (high negative affect). | Mean | Standard Deviation | units on a scale |
|
| Cognition battery Z Scores | We used a composite score of cognition measures including attention-concentration (Continuous Performance Test), verbal and working memory (Hopkins Verbal Learning Test), and processing speed (Trail Making Test Part A), as well as cognitive flexibility (Trail Making Test Part B) and inhibitory control (Stroop subtest) with measures from the DKEFS (Delis-Kaplan Executive Functioning System). For each individual, we normalized each of their scale scores and calculated a mean of these scores. This mean served as the individual's composite cognition score. | Mean | Standard Deviation | units on a scale |
|
| Cigarettes per day | Self-reported number of cigarettes smoked per day. | Mean | Standard Deviation | cigarettes |
|
| Fagerstrom dependence score | The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. Yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. | Mean | Standard Deviation | units on a scale |
|
| OG001 | National Cancer Institute (NCI) Computerized Education | The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition [162] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc). |
|
|
| Secondary | 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). | Posted | Number | participants | 6 months |
|
|
|
| Secondary | Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 1 |
| 78 |
| 0 |
| 78 |
| EG001 | Educational Intervention | The control intervention that is comparable to previous research - a pamphlet that provides education and advice to quit in computerized form. We have computerized a publicly available educational pamphlet (with advice to quit) for the usual care control condition [162] (Appendix B). This control program is designed with similar usability features to the intervention program, but does not contain any of the features believed to increase the efficacy of our active intervention (interactive assessment and feedback, video role models, etc). | 0 | 84 | 1 | 84 |
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