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Electronic Decision Support Systems for Smokers With Severe Mental Illness

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ClinicalTrials.gov Identifier: NCT01412866
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : September 28, 2012
Sponsor:
Collaborators:
U.S. Department of Education
Bristol-Myers Squibb
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:

Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood disorders) smoke cigarettes, and most suffer related health consequences. Although combined treatment with medication and psychosocial therapy can help people with SMI to quit smoking, it is rarely used. Motivational interventions can enhance the use of combined treatment, but motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and Thresholds investigators have developed an easy-to-use, web-based electronic decision support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has demonstrated excellent usability and increased engagement in smoking cessation treatments.

One critical issue is the use of personalized health feedback. Motivational interventions for smoking cessation for smokers with SMI, including our EDSS, have included personal feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to implement, and largely unavailable in public mental health and primary care clinics. Further, research on use of carbon monoxide monitoring in the general population is equivocal. Another motivational strategy to personalize the negative health effects of smoking is a health checklist with feedback. Health checklists have been shown to be effective, are easy to use, have no expense, but have not been assessed separately from carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the health checklist compared to feedback from the carbon monoxide monitor is an essential next step in the development of this tool.

Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist feedback alone.

Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist feedback leads to higher rates of the distal outcomes, days of smoking abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.


Condition or disease Intervention/treatment Phase
Severe Mental Illness Nicotine Dependence Behavioral: Electronic decision support system with CO monitor feedback Behavioral: Electronic decision support system without CO monitor feedback Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: EDSS with CO monitor feedback Behavioral: Electronic decision support system with CO monitor feedback
Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist
Experimental: EDSS without CO monitor feedback Behavioral: Electronic decision support system without CO monitor feedback
Web-based electronic decision support system (EDSS) with health-checklist feedback alone



Primary Outcome Measures :
  1. Initiation of smoking cessation treatment [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Days of nicotine abstinence [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult age 18-75
  • in treatment for severe mental illness,
  • current smoker,
  • physically able to use a computer

Exclusion Criteria:

  • Using smoking cessation treatment in past month,
  • substance dependence with current use

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 ClinicalTrials.gov identifier (NCT number): NCT01412866


Locations
United States, Illinois
Thresholds Psychiatric Rehabilitation Center
Chicago, Illinois, United States
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
U.S. Department of Education
Bristol-Myers Squibb
Investigators
Principal Investigator: Mary F Brunette, MD Dartmouth-Hitchcock Medical Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01412866     History of Changes
Other Study ID Numbers: EDSS1
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012

Keywords provided by Dartmouth-Hitchcock Medical Center:
schizophrenia
severe mental illness
nicotine
smoking
motivation
electronic decision support system
motivational interviewing

Additional relevant MeSH terms:
Tobacco Use Disorder
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders