An interventional study of Web-based motivational decision support system and NCI Education in Schizophrenia, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 3 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-29.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment
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 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 explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 184 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Web-based motivational decision support system
Behavioral: Web-based motivational decision support system
Computerized version of the National Cancer Institute (NCI) Educational Pamphlet
Behavioral: NCI Education
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
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
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence
Time frame: 6 months
| Milestone | Let's Talk About Smoking | National Cancer Institute (NCI) Computerized Education |
|---|---|---|
| Started | 78 | 84 |
| Completed | 68 | 77 |
| Not completed | 10 | 7 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Moved | 1 | 1 |
| Withdrew: Lost to follow-up | 4 | 2 |
| Withdrew: Death | 1 | 0 |
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.
| participants | Let's Talk About Smoking | National Cancer Institute (NCI) Computerized Education |
|---|---|---|
| Number of Subjects That Initiated Cessation Treatment | 27 | 36 |
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).
| participants | Let's Talk About Smoking | National Cancer Institute (NCI) Computerized Education |
|---|---|---|
| Number of Subjects With Confirmed Abstinence | 1 | 6 |
| Participants | Behavioral Intervention | Educational Intervention |
|---|---|---|
| Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence | 13 | 11 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Behavioral Intervention | — | 1/78 (1.3%) | 0/78 (0%) |
| Educational Intervention | — | 0/84 (0%) | 1/84 (1.2%) |
| Event | Behavioral Intervention | Educational Intervention |
|---|---|---|
| DeathCardiac disorders | 1/78 | 0/84 |
| Event | Behavioral Intervention | Educational Intervention |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 0/78 | 1/84 |
| Age, Continuous(years) | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| Mean | 47.62 ± 11.29 | 44.32 ± 11.18 | 45.91 ± 11.32 |
| Sex: Female, Male(Participants) | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| Female | 29 | 25 | 54 |
| Male | 49 | 59 | 108 |
| Region of Enrollment(participants) | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| United States | 78 | 84 | 162 |
| Brief Psychiatric Rating Scale(units on a scale) | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| Mean | 41.79 ± 11.95 | 40.38 ± 10.32 | 41.06 ± 11.11 |
| Positive and Negative Affect Schedule - Positive(units on a scale) | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| Mean | 22.36 ± 8.66 | 22.31 ± 8.48 | 22.33 ± 8.54 |
| Positive and Negative Affect Schedule - Negative(units on a scale) | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| Mean | 12.04 ± 9.09 | 12.06 ± 9.45 | 12.05 ± 9.25 |
| Cognition battery Z Scores(units on a scale) | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| Mean | -.029 ± 0.68 | .016 ± 0.70 | -.006 ± 0.69 |
| Cigarettes per day(cigarettes) | Behavioral Intervention | Educational Intervention | Total |
|---|---|---|---|
| Mean | 14.48 ± 9.62 | 14.64 ± 11.3 | 14.56 ± 10.49 |
1 further baseline measures are reported on the registry.
Plan to share: Yes — 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).
Supporting information: Study protocol
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center