Schizophrenia Clinical Trial
— RCTEDSSOfficial title:
RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses
Verified date | November 2018 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 184 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Thresholds | Chicago | Illinois |
United States | Rutgers-UNDMJ | New Brunswick | New Jersey |
United States | University of Massachusetts | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 6 months | |
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). | 6 months | |
Secondary | Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence | 6 months |
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