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

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ClinicalTrials.gov Identifier: NCT02086162
Recruitment Status : Completed
First Posted : March 13, 2014
Results First Posted : October 12, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mary F. Brunette, MD, 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Web-based motivational decision support system Behavioral: NCI Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses
Study Start Date : April 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Behavioral intervention
Web-based motivational decision support system
Behavioral: Web-based motivational decision support system
Active Comparator: Educational intervention
Computerized version of the National Cancer Institute (NCI) Educational Pamphlet
Behavioral: NCI Education



Primary Outcome Measures :
  1. Number of Subjects That Initiated Cessation Treatment [ Time Frame: 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 :
  1. Number of Subjects With Confirmed Abstinence [ Time Frame: 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).

  2. Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086162


Locations
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United States, Illinois
Thresholds
Chicago, Illinois, United States, 60613
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01605
United States, New Jersey
Rutgers-UNDMJ
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mary F. Burnette, MD Dartmouth-Hitchcock Medical Center

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Responsible Party: Mary F. Brunette, MD, Staff Physician, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02086162     History of Changes
Other Study ID Numbers: FED14095
R01CA168778 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2014    Key Record Dates
Results First Posted: October 12, 2018
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

De-identified research data files will be made available to all researchers in both the public and private sectors for potential statistical analyses or re-analyses in accordance with the NIH data Sharing Policy: http://grants.nih.gov/grants/policy/data sharing. Data will be available 2 years after data collection is completed, or after primary papers have been accepted for publication. Data will only be transferred to other researchers under a signed data sharing agreement.

Materials and research data files will be made available, upon request, from the PI. These requests can be made via email (mary.f.brunette@dartmouth.edu).

Supporting Materials: Study Protocol
Time Frame: Data will be available for sharing after we complete our analyses, estimated to be in January 2020.
Access Criteria: Investigators wishing to access data will submit a request with an analysis plan, data management plan and data safety plan to the PI. A signed data sharing agreement will be developed prior to release of the data.

Keywords provided by Mary F. Brunette, MD, Dartmouth-Hitchcock Medical Center:
Schizophrenia
Smoking
Tobacco
Motivation
Cessation Treatment

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders