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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01779440
Recruitment Status : Unknown
Verified August 2015 by Dartmouth-Hitchcock Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2013
Last Update Posted : August 19, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

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
Mental Illness Tobacco Smoking Psychotic Disorders Behavioral: Electronic Decision Support System Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness
Study Start Date : January 2013
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in Smoking Cessation Treatment measured by the behavioral Checklist delivered at baseline and 14 weeks [ Time Frame: Baseline and 14 weeks ]
    Assesses through self-report and clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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)

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 identifier (NCT number): NCT01779440

United States, New Hampshire
Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States, 03103
Greater Nashua Mental Health Center
Nashua, New Hampshire, United States, 03060
United States, New York
Zucker-Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Principal Investigator: Mary F. Brunette, MD Dartmouth College

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT01779440     History of Changes
Other Study ID Numbers: R21CA158863-01A1 ( U.S. NIH Grant/Contract )
R21CA158863-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by Dartmouth-Hitchcock Medical Center:
Mental Illness
Tobacco Smoking
Young Adults
Treatment Engagement
Motivational Intervention

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