Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Behavioral: Electronic Decision Support System
|
| Placebo Comparator: Control Computer Program A computer program aimed to educate people about smoking cessation treatment. |
Behavioral: Electronic Decision Support System
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Utilized Smoking Cessation Treatment [14 week follow-up]
Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.
Secondary Outcome Measures
- Number of Participants With Biologically Confirmed Abstinence [14 weeks]
Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mental Health Center of Greater Manchester | Manchester | New Hampshire | United States | 03103 |
| 2 | Greater Nashua Mental Health Center | Nashua | New Hampshire | United States | 03060 |
| 3 | Zucker-Hillside Hospital | Glen Oaks | New York | United States | 11004 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Mary F. Brunette, MD, Dartmouth College
Study Documents (Full-Text)
More Information
Publications
- R21CA158863-01A1
- R21CA158863-01A1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Electronic Decision Support System | Control Computer Program |
|---|---|---|
| Arm/Group Description | 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 | A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System |
| Period Title: Overall Study | ||
| STARTED | 30 | 28 |
| COMPLETED | 27 | 23 |
| NOT COMPLETED | 3 | 5 |
Baseline Characteristics
| Arm/Group Title | Electronic Decision Support System | Control Computer Program | Total |
|---|---|---|---|
| Arm/Group Description | 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 | A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System | Total of all reporting groups |
| Overall Participants | 30 | 28 | 58 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
23.5
(3.9)
|
25.0
(3.2)
|
24.2
(3.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
10
33.3%
|
9
32.1%
|
19
32.8%
|
| Male |
20
66.7%
|
19
67.9%
|
39
67.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Caucasian |
17
56.7%
|
16
57.1%
|
33
56.9%
|
| African American |
9
30%
|
10
35.7%
|
19
32.8%
|
| Other race |
4
13.3%
|
2
7.1%
|
6
10.3%
|
| Mean cigarettes per day (cigarettes) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cigarettes] |
10.9
(8.6)
|
13.9
(9.4)
|
12.3
(9.0)
|
Outcome Measures
| Title | Number of Participants Who Utilized Smoking Cessation Treatment |
|---|---|
| Description | Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment. |
| Time Frame | 14 week follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Electronic Decision Support System | Control Computer Program |
|---|---|---|
| Arm/Group Description | 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 | A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System |
| Measure Participants | 27 | 23 |
| Count of Participants [Participants] |
2
6.7%
|
1
3.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Electronic Decision Support System, Control Computer Program |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | The P-Value of 0.65 was calculated from the difference between groups for the above outcome variable. | |
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants With Biologically Confirmed Abstinence |
|---|---|
| Description | Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm |
| Time Frame | 14 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who attended the follow-up assessment |
| Arm/Group Title | Electronic Decision Support System | Control Computer Program |
|---|---|---|
| Arm/Group Description | 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 | A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System |
| Measure Participants | 27 | 23 |
| Count of Participants [Participants] |
4
13.3%
|
0
0%
|
Adverse Events
| Time Frame | 14 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Electronic Decision Support System | Control Computer Program | ||
| Arm/Group Description | 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 | A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System | ||
All Cause Mortality |
||||
| Electronic Decision Support System | Control Computer Program | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/28 (0%) | ||
Serious Adverse Events |
||||
| Electronic Decision Support System | Control Computer Program | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/28 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Electronic Decision Support System | Control Computer Program | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/28 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Mary F. Brunette, MD |
|---|---|
| Organization | Dartmouth-Hitchcock |
| Phone | 603-229-5419 |
| Mary.F.Brunette@hitchcock.org |
- R21CA158863-01A1
- R21CA158863-01A1