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OpenTrials
Completed

NCT Number: NCT01412866

Electronic Decision Support Systems for Smokers With Severe Mental Illness

This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thresholds Psychiatric Rehabilitation Center

Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EDSS with CO feedback and health checklist

Behavioral

Web-based electronic decision support system with CO feedback and health-checklist

EDSS with health checklist feedback alon

Behavioral

Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)

Primary outcomes

  1. Initiation of Smoking Cessation Treatment

    Time frame: 2 months

    Started smoking cessation treatment

Secondary outcomes

  1. Days of Nicotine Abstinence

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Bristol-Myers Squibb
  • U.S. Department of Education

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 9, 2011
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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