CSP #519 - Integrating Practice Guidelines for Smoking Cessation Into Mental Health Care for PTSD (SCP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 943
- 试验地点
- 22
- 主要终点
- Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization
研究概览
简要总结
The primary study objective is to conduct a prospective, randomized controlled clinical trial that compares the effectiveness of two approaches for delivering smoking cessation treatment for veterans with posttraumatic stress disorder (PTSD). An approach where smoking cessation treatment is integrated into mental health care for PTSD and delivered by mental health providers (experimental condition) will be compared to specialized smoking cessation clinic referral (VA's usual standard of care).
Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC versus USC, (b) identify treatment process variables that explain (mediate) observed differences in smoking abstinence rates for the two study conditions, and (c) determine whether cessation from smoking is associated with worsening of symptoms of PTSD and/or depression.
详细描述
Intervention: The research will test the effectiveness of integrating evidence-based, efficacious treatments for tobacco use disorder into mental health care for patients with chronic PTSD. Two different methods for delivering smoking cessation treatment will be compared in a randomized, controlled clinical effectiveness trial conducted at four Department of Veterans Affairs (VA) medical centers. Smokers undergoing mental health care for PTSD who want to quit smoking will be randomly assigned to either (1) guideline-concordant smoking cessation treatment integrated within ongoing mental health care for PTSD, and delivered by mental health providers (Integrated Care (IC), experimental condition), or (2) specialized smoking cessation treatment, delivered separately from PTSD treatment by a smoking cessation clinic (Usual Standard of Care (USC), comparison condition).
Primary Hypothesis: IC will be more effective than USC on measures of smoking-related clinical outcomes.
Secondary Hypothesis: The following treatment process variables will predict smoking abstinence at 12-months post randomization: (a) number of smoking cessation treatment sessions received, (b) type and duration of protocol medications prescribed by providers (bupropion, transdermal nicotine patch, and nicotine gum), (c) degree of subjects' compliance with prescribed protocol medication, and (d) number of quit attempts marked by abstinence of 7 days or more.
Treatment process variables that predict smoking abstinence will be present to a significantly greater degree in IC than USC.
Primary Outcomes: The primary outcome measure will be the point-prevalence of smoking abstinence by self-report for the 7 days prior to assessments, obtained at months 3, 6, 9, and 12 following randomization to study conditions. Verification of smoking abstinence will be obtained by CO readings (abstinence < 10 ppm) obtained at each assessment interval. Salivary cotinine levels (abstinence < 20 ng/ml) will be measured to verify abstinence at months 9 and 12 only, as subjects may still be using nicotine replacement medicines at earlier assessment intervals, confounding cotinine assays.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Receive a minimum of four mental health treatment sessions from the SOPP that span at least a 1-month interval
- •SOPP treatment plan must indicate intent to deliver ongoing PTSD care for at least 1 year, including visits at least once per month
- •Diagnosis of PTSD resulting from military trauma using DSM-IV criteria
- •Current nicotine use, smoking greater at least 10 cigarettes per day for at least 16 of the past 30 days prior to randomization
- •Demonstrated motivation to quit smoking
排除标准
- •Use of smokeless tobacco or smoke pipes or cigars
- •Any psychotic disorder that is not in remission
- •Bipolar disorder that is not in remission
- •Any substance dependence disorder that is not in remission (current substance abuse disorder and substance dependence disorder in remission for more than 1 month are not exclusions)
- •Imminent risk for suicide or violence, as determined during routine assessment by SOPP clinical staff
- •Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions), as determined during routine assessment by SOPP clinical staff
- •Gross impairment from organic mental disorder, as determined during routine assessment by SOPP clinical staff
结局指标
主要结局
Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization
时间窗: between 6 and 18 months
The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine \<100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.
次要结局
- Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months(between 6 and 18 months)
- Clinician Administered PTSD Scale (CAPS)(Baseline and 18 months)
- PTSD Checklist(Baseline and 18 months)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline and 18 months)
- Patient Health Questionnaire (PHQ-9)(Baseline and 15 months)
- 7-day Point Prevalence Abstinence - Self Reported(18 months)
- 7-day Point Prevalence Abstinence - Bio-Verified(18 months)
- 30-day Point Prevalence Abstinence - Self Reported(18 months)
- 30-day Point Prevalence Abstinence - Bio-Verified(18 months)