Randomized Controlled Trial (RCT) of a Motivational Decision Support System
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

Intervention name(s): Web-based motivational decision support system; NCI Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Smoking; Tobacco; Motivation; Cessation Treatment