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Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness

Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01779440
Enrollment
58
Registered
2013-01-30
Start date
2013-01-01
Completion date
2018-02-22
Last updated
2018-06-27

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

Conditions

Mental Illness, Psychotic Disorders, Tobacco Smoking

Keywords

Mental Illness, Tobacco Smoking, Young Adults, Treatment Engagement, Motivational Intervention

Brief summary

Up to 77% of young people with severe mental illnesses smoke, a rate that is up to five times higher than the rate of daily smoking in other young adults. Contrary to popular belief, smoking tobacco does not provide any benefit for mental illness symptom control. People with severe mental illnesses (SMI: schizophrenia and severe mood disorders) are dying, on average, 25 years earlier than those without SMI. Much of this early mortality is due to higher rates of heart and lung diseases, cancers, strokes, and diabetes. Cessation of smoking in these transition-age young adults can prevent cancer and increase life expectancy to that of non-smokers. Combination treatments are effective in this group and therefore key to improving outcomes, but few SMI smokers use them despite their interest in quitting. Motivational interventions for cessation increase interest in quitting, but public mental health clinicians do not deliver them, in part due to economic reasons. Thus cost effective methods to deliver motivational interventions to engage young smokers with SMI into treatment are needed. To address this gap, we have developed an electronic decision support system (EDSS) for smoking cessation that is specifically tailored for smokers with SMI, who tend to have cognitive deficits and limited computer experience. Similar to EDSSs developed for other health problems, this EDSS provides information and motivational exercises within an easy-to-use, web-based computer program that can be used with minimal or no staff assistance. Initial piloting of the EDSS in middle-aged SMI smokers showed excellent usability and promising efficacy. Pilot-testing among young patients suggested that the EDSS increased motivation to quit smoking and provided direction to adapt the format and content of the EDSS for young SMI smokers. The purpose of this proposal is to further develop the motivational decision support system and to test its ability to motivate young smokers with SMI to quit smoking with cessation treatment.

Detailed description

The research will take place over 2 years at the Long Island Zucker Hillside Hospital system. In Year 1, we will adapt our electronic decision support system, a web-based motivational tool, for young smokers with severe mental illness. We will first identify beliefs of young smokers with severe mental illness that impede use of smoking cessation treatments. Then, the decision support system will be revised to change these beliefs, field-tested for usability, and improved as needed. In Year 2, we will conduct a randomized control trial of the newly revised version of the system among 60 young smokers with severe psychotic disorders. In the controlled trial, participants will be assessed at baseline for mental health symptoms and smoking behavior and history, and then randomized to use the system or a computerized public health pamphlet (control condition) within two weeks. Participants will be assessed again at 14-week follow-up for clinician-confirmed initiation of smoking cessation treatment (main outcome), beliefs, and smoking characteristics. Analyses will assess whether use of the decision support system results in greater initiation of cessation treatment (main outcome), and changes in beliefs about treatment, than use of the control intervention.

Interventions

BEHAVIORALElectronic Decision Support System

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

English-speaking; non-pregnant/nursing; daily smokers; age 18-30; psychiatrically stable; in treatment in the Zucker Hillside Hospital system; diagnosed with SMI (schizophrenia, schizoaffective disorder, or mood disorder with psychotic features from medical chart); willing and able to give informed consent.

Exclusion criteria

(Phase 4 only): current (within the past month) use of evidence-based smoking cessation treatment (indicating the subject is already motivated), psychiatric instability (Modified Colorado Symptom Index score \>45), current untreated substance use disorder (SUD)

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Utilized Smoking Cessation Treatment14 week follow-upAssesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.

Secondary

MeasureTime frameDescription
Number of Participants With Biologically Confirmed Abstinence14 weeksAbstinence - self report for past 7 days confirmed with breath Carbon Monoxide \<9 ppm

Countries

United States

Participant flow

Participants by arm

ArmCount
Electronic Decision Support System
The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment. Electronic Decision Support System
30
Control Computer Program
A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System
28
Total58

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject35

Baseline characteristics

CharacteristicElectronic Decision Support SystemControl Computer ProgramTotal
Age, Continuous23.5 years
STANDARD_DEVIATION 3.9
25.0 years
STANDARD_DEVIATION 3.2
24.2 years
STANDARD_DEVIATION 3.4
Mean cigarettes per day10.9 cigarettes
STANDARD_DEVIATION 8.6
13.9 cigarettes
STANDARD_DEVIATION 9.4
12.3 cigarettes
STANDARD_DEVIATION 9
Race/Ethnicity, Customized
African American
9 Participants10 Participants19 Participants
Race/Ethnicity, Customized
Caucasian
17 Participants16 Participants33 Participants
Race/Ethnicity, Customized
Other race
4 Participants2 Participants6 Participants
Sex: Female, Male
Female
10 Participants9 Participants19 Participants
Sex: Female, Male
Male
20 Participants19 Participants39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 28
other
Total, other adverse events
0 / 300 / 28
serious
Total, serious adverse events
0 / 300 / 28

Outcome results

Primary

Number of Participants Who Utilized Smoking Cessation Treatment

Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.

Time frame: 14 week follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Electronic Decision Support SystemNumber of Participants Who Utilized Smoking Cessation Treatment2 Participants
Control Computer ProgramNumber of Participants Who Utilized Smoking Cessation Treatment1 Participants
p-value: 0.65Chi-squared
Secondary

Number of Participants With Biologically Confirmed Abstinence

Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide \<9 ppm

Time frame: 14 weeks

Population: Participants who attended the follow-up assessment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Electronic Decision Support SystemNumber of Participants With Biologically Confirmed Abstinence4 Participants
Control Computer ProgramNumber of Participants With Biologically Confirmed Abstinence0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026