Randomized Controlled Trial (RCT) of a Motivational Decision Support System

Completed · Not applicable

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02086162

Run by

Dartmouth-Hitchcock Medical Center

People needed

184

Starts

2014-04-01

Expected to finish

2016-07-01

Last updated by the study team

2018-11-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• past 2 weeks use of evidence based cessation treatment
• psychiatric instability
• current alcohol or drug dependence
• pregnant or nursing

Where it is running

• Thresholds — Chicago, Illinois, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Rutgers-UNDMJ — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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