Randomized Controlled Trial (RCT) of a Motivational Decision Support System
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/1/2018 |
| Start Date: | April 2014 |
| End Date: | July 2016 |
RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses
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.
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.
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.
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.
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
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