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

RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02086162
Acronym
RCTEDSS
Enrollment
184
Registered
2014-03-13
Start date
2014-04-30
Completion date
2016-07-31
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Smoking, Tobacco, Motivation, Cessation 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.

Interventions

BEHAVIORALWeb-based motivational decision support system
BEHAVIORALNCI Education

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Subjects That Initiated Cessation Treatment6 monthsCessation 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

MeasureTime frameDescription
Number of Subjects With Confirmed Abstinence6 monthsBiologically 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).
Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence6 months

Countries

United States

Participant flow

Pre-assignment details

After participating in an informed consent process, 184 subjects were assessed for eligibility. 11 were ineligible and 11 declined or were unable to proceed with the study for other reasons. 162 were randomized and proceeded to receive an intervention.

Participants by arm

ArmCount
Behavioral Intervention
Web-based motivational decision support system
78
Educational Intervention
Computerized version of the National Cancer Institute (NCI) Educational Pamphlet NCI Education
84
Total162

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath10
Overall StudyLost to Follow-up42
Overall Studymoved11
Overall StudyWithdrawal by Subject44

Baseline characteristics

CharacteristicBehavioral InterventionEducational InterventionTotal
Age, Continuous47.62 years
STANDARD_DEVIATION 11.29
44.32 years
STANDARD_DEVIATION 11.18
45.91 years
STANDARD_DEVIATION 11.32
Brief Psychiatric Rating Scale41.79 units on a scale
STANDARD_DEVIATION 11.95
40.38 units on a scale
STANDARD_DEVIATION 10.32
41.06 units on a scale
STANDARD_DEVIATION 11.11
Cigarettes per day14.48 cigarettes
STANDARD_DEVIATION 9.62
14.64 cigarettes
STANDARD_DEVIATION 11.3
14.56 cigarettes
STANDARD_DEVIATION 10.49
Cognition battery Z Scores-.029 units on a scale
STANDARD_DEVIATION 0.68
.016 units on a scale
STANDARD_DEVIATION 0.7
-.006 units on a scale
STANDARD_DEVIATION 0.69
Fagerstrom dependence score5.03 units on a scale
STANDARD_DEVIATION 2.19
5.30 units on a scale
STANDARD_DEVIATION 1.8
5.16 units on a scale
STANDARD_DEVIATION 2
Positive and Negative Affect Schedule - Negative12.04 units on a scale
STANDARD_DEVIATION 9.09
12.06 units on a scale
STANDARD_DEVIATION 9.45
12.05 units on a scale
STANDARD_DEVIATION 9.25
Positive and Negative Affect Schedule - Positive22.36 units on a scale
STANDARD_DEVIATION 8.66
22.31 units on a scale
STANDARD_DEVIATION 8.48
22.33 units on a scale
STANDARD_DEVIATION 8.54
Region of Enrollment
United States
78 participants84 participants162 participants
Sex: Female, Male
Female
29 Participants25 Participants54 Participants
Sex: Female, Male
Male
49 Participants59 Participants108 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 781 / 84
serious
Total, serious adverse events
1 / 780 / 84

Outcome results

Primary

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.

Time frame: 6 months

ArmMeasureValue (NUMBER)
Let's Talk About SmokingNumber of Subjects That Initiated Cessation Treatment27 participants
National Cancer Institute (NCI) Computerized EducationNumber of Subjects That Initiated Cessation Treatment36 participants
Secondary

Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Let's Talk About SmokingNumber of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence13 Participants
National Cancer Institute (NCI) Computerized EducationNumber of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence11 Participants
Secondary

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).

Time frame: 6 months

ArmMeasureValue (NUMBER)
Let's Talk About SmokingNumber of Subjects With Confirmed Abstinence1 participants
National Cancer Institute (NCI) Computerized EducationNumber of Subjects With Confirmed Abstinence6 participants

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026