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临床试验/NCT02086162
NCT02086162已完成不适用

RCT of a Motivational Decision Support System for Smokers With Severe Mental Illnesses

Dartmouth-Hitchcock Medical Center3 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
3
主要终点
Number of Subjects That Initiated Cessation Treatment

研究概览

简要总结

In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. The Specific Aims of the study are:

  1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence.

  2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed.

  3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months

  4. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

  5. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

详细描述

Up to 80% of people with schizophrenia and schizoaffective disorders smoke - a rate that is four times the rate in the general population. Cessation treatments are effective, but these smokers don't use them. In order to provide an easy-to-use, cost-effective strategy to engage this group of smokers into effective treatments, we developed a single-session, web-based, motivational decision support system, Let's Talk About Smoking. The system incorporates features that insure high usability among those who can't use current websites due to cognitive impairments and low computer skills. It provides compelling content that engages users into evidence-based cessation treatments.

In this study we will definitively test the decision support system in a randomized controlled trial (RCT) among smokers with severe mental illness (SMI) psychotic disorders. Our proposed study design will enable us to test whether this system, designed for those with cognitive impairments, is effective among people with a range of cognitive abilities. The Specific Aims of the study are:

  1. To determine whether use of the web-based decision support system leads to higher rates of initiation of smoking cessation treatment than use of a computerized educational pamphlet. We will also assess effectiveness on secondary outcomes, including smoking behavior, urges and outcome expectancies; level of dependence; intentions to quit and to use cessation treatment; and abstinence.

  2. To assess whether cognitive ability moderates initiation of smoking cessation treatment. Since cognitive impairment impedes use of standard web-based interventions by this group, and cognitive impairments likely supersede other potential moderators (education and socioeconomic status), this aim will be key to determining the success of our intervention and will guide further revisions if they are needed.

  3. To explore the effects of the decision support system and baseline cognitive ability on abstinence over 6 months

  4. We will examine the impact of the DSS on 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

  5. We will determine whether baseline cognition (scale scores) is associated with 7-day point prevalence tobacco abstinence at 6 months, and cumulative days of tobacco abstinence over 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-70 years old
  • •DSM-IV-TR diagnosis psychotic disorder
  • •in treatment at participating mental health center
  • •current daily smoker
  • •fluent in English
  • •physically able to use computer
  • •willing and able to give informed consent

排除标准

  • •past 2 weeks use of evidence based cessation treatment
  • •psychiatric instability
  • •current alcohol or drug dependence
  • •pregnant or nursing

研究组 & 干预措施

Behavioral intervention

Experimental

Web-based motivational decision support system

干预措施: Web-based motivational decision support system (Behavioral)

Educational intervention

Active Comparator

Computerized version of the National Cancer Institute (NCI) Educational Pamphlet

干预措施: NCI Education (Behavioral)

结局指标

主要结局

Number of Subjects That Initiated Cessation Treatment

时间窗: 6 months

Cessation treatment initiation and engagement will be collected from clinician attendance sheets in the medical record and medical record review for prescriptions. Medication use will be confirmed with self-report of taking medication.

次要结局

  • Number of Subjects With Confirmed Abstinence(6 months)
  • Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary F. Brunette, MD

Staff Physician

Dartmouth-Hitchcock Medical Center

研究点 (3)

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