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

Dartmouth Health

Status: Completed

Conditions: Schizophrenia

Treatments: Behavioral: NCI Education; Behavioral: Web-based motivational decision support system

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02086162

FED14095

R01CA168778 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Behavioral intervention

Experimental group

Description:

Web-based motivational decision support system

Treatment:

Behavioral: Web-based motivational decision support system

Educational intervention

Active Comparator group

Description:

Computerized version of the National Cancer Institute (NCI) Educational Pamphlet

Treatment:

Behavioral: NCI Education