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

NCT ID: NCT02086162

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-07-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral intervention

Web-based motivational decision support system

Group Type: EXPERIMENTAL

Web-based motivational decision support system

Intervention Type: BEHAVIORAL

Educational intervention

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

Group Type: ACTIVE_COMPARATOR

NCI Education

Intervention Type: BEHAVIORAL

Interventions

Web-based motivational decision support system

Intervention Type: BEHAVIORAL

NCI Education

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mary F. Brunette, MD

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary F. Burnette, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Thresholds

Chicago, Illinois, United States

University of Massachusetts

Worcester, Massachusetts, United States

Rutgers-UNDMJ

New Brunswick, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32039811 (View on PubMed)

Other Identifiers

R01CA168778

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FED14095

Identifier Type: -

Identifier Source: org_study_id