SchizophreniaRCTEDSSNCT02086162
Randomized Controlled Trial (RCT) of a Motivational Decision Support System
A study testing Web-based motivational decision support system and NCI Education in people with Schizophrenia, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Web-based motivational decision support system and NCI Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- past 2 weeks use of evidence based cessation treatment
- psychiatric instability
- current alcohol or drug dependence
- pregnant or nursing
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Thresholds
Chicago, Illinois, 60613
Rutgers-UNDMJ
New Brunswick, New Jersey, 08901
University of Massachusetts
Worcester, Massachusetts, 01605
About this study
Official title: RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses
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:
- 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.
- 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.
- To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
- 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.
- 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.
Read the 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:
- 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.
- 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.
- To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
- 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.
- 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
- Being tested
- Web-based motivational decision support system, NCI Education
- Keywords
- Schizophrenia, Smoking, Tobacco, Motivation, Cessation Treatment
- Medical subject headings
- Schizophrenia, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based motivational decision support systemBehavioural
NCI EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | Web-based motivational decision support system Receives: Behavioral: Web-based motivational decision support system |
| Educational intervention | Active comparator | Computerized version of the National Cancer Institute (NCI) Educational Pamphlet Receives: Behavioral: NCI Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects That Initiated Cessation Treatment
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.
Measured: 6 months
Secondary outcomes (2)
Number of Subjects With Confirmed Abstinence
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).
Measured: 6 months
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mary F. Brunette, MD, Dartmouth-Hitchcock Medical Center
- Investigators
- Mary F. Burnette, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086162
- Sponsor's protocol ID
- FED14095
- Other IDs
- R01CA168778
- Acronym
- RCTEDSS
- Status last verified
- Nov 2018
- First submitted
- 11 Mar 2014
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 32039811
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses
- ClinicalTrials.gov ID
- NCT02086162
- Acronym / sponsor ID
- RCTEDSS / FED14095
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Smoking, Tobacco, Motivation, Cessation Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Posted 12 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
- 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.
- 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:
- 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.
- 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.
- To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Web-based motivational decision support systemWeb-based motivational decision support system |
| Educational intervention | Active comparator | Behavioral: NCI EducationComputerized version of the National Cancer Institute (NCI) Educational Pamphlet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-70 years old
- DSM-IV-TR diagnosis psychotic disorder
- in treatment at participating mental health center
- current daily smoker
- fluent in English
Key exclusion criteria (4 listed)
- past 2 weeks use of evidence based cessation treatment
- psychiatric instability
- current alcohol or drug dependence
- pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based motivational decision support system | Behavioural | Behavioral intervention |
| NCI Education | Behavioural | Educational intervention |
Primary outcome
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.
2 secondary outcomes
Number of Subjects With Confirmed Abstinence
Time frame: 6 months
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32039811Brunette 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary F. Burnette, MD principal investigator
Dartmouth-Hitchcock Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based motivational decision support system and NCI Education in people with Schizophrenia, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects That Initiated Cessation Treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.