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

Not Applicable

Completed

Conditions: Schizophrenia

Interventions: Behavioral: Web-based motivational decision support system
Behavioral: NCI Education

Registration Number: NCT02086162

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 184

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral intervention	Web-based motivational decision support system	Web-based motivational decision support system
Educational intervention	NCI Education	Computerized version of the National Cancer Institute (NCI) Educational Pamphlet

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Initiated Cessation Treatment	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Confirmed Abstinence	6 months	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).
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence	6 months

Trial Locations

Locations (3): University of Massachusetts
🇺🇸
Worcester, Massachusetts, United States
Thresholds
🇺🇸
Chicago, Illinois, United States
Rutgers-UNDMJ
🇺🇸
New Brunswick, New Jersey, United States