Clinical trial NCT02086162: Randomized Controlled Trial (RCT) of a Motivational Decision Support System
Official title: RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Smoking
Tobacco
Motivation
Cessation Treatment
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-13
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects That Initiated Cessation Treatment
timeFrame: 6 months
Secondary outcomes:
measure: Number of Subjects With Confirmed Abstinence
timeFrame: 6 months
measure: Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Thresholds
state: Illinois
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: New Brunswick
country: United States
facility: Rutgers-UNDMJ
state: New Jersey
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Mary F. Burnette, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunette MF, Ferron JC, McGurk SR, Williams JM, Harrington A, Devitt T, Xie H. Brief, Web-Based Interventions to Motivate Smokers With Schizophrenia: Randomized Trial. JMIR Ment Health. 2020 Feb 8;7(2):e16524. doi: 10.2196/16524.