跳至主要内容
临床试验/NCT01901848
NCT01901848已完成2 期

Combined Smoking Cessation and Cognitive Processing Therapy for PTSD

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2013年12月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
69
试验地点
1
主要终点
Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up.

研究概览

简要总结

Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though research suggests smoking is linked with PTSD symptoms, existing smoking cessation treatments targeting PTSD smokers do not include PTSD treatment. The purpose of this study is to examine a treatment that combines evidence based treatment for PTSD (cognitive processing therapy, or CPT) with smoking cessation treatment for PTSD and a mobile text messaging program. The study objectives are to evaluate feasibility of the treatment and to examine effectiveness of CPT and smoking cessation treatment combined compared to smoking cessation treatment without CPT. Fifty Veteran smokers with PTSD will participate in fourteen study sessions, ending with the final follow-up session six months after the scheduled quit date.

详细描述

Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though naturalistic and laboratory studies suggest smoking is linked with PTSD symptoms, existing smoking cessation treatments targeting PTSD smokers have not utilized standardized, evidence-based PTSD treatment. The most effective smoking cessation approach to date for PTSD smokers, Integrated Care for Smoking Cessation (ICSC), relies on delivery of smoking cessation treatment by the individual's PTSD treatment provider. In a recent trial comparing ICSC to VA specialty Smoking Cessation Clinic care, ICSC produced significantly better prolonged smoking abstinence. However, ICSC was associated with only modest improvements in PTSD symptoms, with no difference between ICSC and smoking cessation treatment alone, suggesting a likely avenue for improving ICSC. The investigators have developed an intervention that combines evidence based treatment for PTSD [cognitive processing therapy (CPT-C)] with evidence based smoking cessation for PTSD [Integrated Care for Smoking Cessation (ICSC)] and a mobile text messaging program. The primary aim of the proposed study is to evaluate the integration of CPT-C and smoking cessation treatment in an individual 12-session PTSD protocol as compared to a protocol including the same smoking cessation treatment for individuals with PTSD, but without CPT-C. This intervention will be evaluated with the following hypotheses:

  1. Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced frequency and intensity of PTSD symptoms.
  2. Compared to the smoking cessation alone protocol, the smoking cessation + concurrent CPT-C protocol will result in reduced depressive symptoms.
  3. The smoking cessation + concurrent CPT-C protocol will result in decreased smoking rates, relative to published data on VA smoking cessation usual care.
  4. Greater PTSD symptom reduction during the smoking cessation + concurrent CPT-C treatment will result in longer duration to smoking lapse and relapse.
  5. Exploratory research question: Will candidate genes described earlier predict treatment response in smokers with PTSD?
  6. Exploratory research question: Will use of automated text messaging as an adjunct to smoking cessation be feasible, and will it impact quit rates?

The development of a combined CPT-C/ICSC intervention with established empirical support would benefit the many Veterans with PTSD who smoke by providing them with treatment of two pervasive problems with significant associated impairment. In addition, this treatment could substantially reduce the cost of administering two individual treatments separately by administering them in combination.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be U.S. Veteran
  • Smoke at least ten cigarettes a day
  • Meet criteria for current PTSD
  • Speak and write fluent conversational English
  • Be between 18 and 65 years of age
  • Be willing to attempt smoking cessation
  • Must have access to a phone capable of receiving text messages

排除标准

  • Not stable on medications for the study period
  • History of myocardial infarction in the past 6 months
  • Contraindication to NRT and inability to get medical clearance from primary care provider
  • Use of other forms of nicotine such as cigars, pipes, or chewing tobacco.
  • Pregnancy
  • Inability to complete study measures and tasks independently
  • Dementia or other brain disorder, schizophrenia, current manic syndrome, or substance abuse/dependence in the preceding 3 months.
  • Currently receiving trauma-focused psychotherapy.
  • Currently living in court-ordered residential substance abuse treatment.

研究组 & 干预措施

CPT+ICSC

Experimental

This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: Cognitive Processing Therapy (CPT) (Behavioral)

CPT+ICSC

Experimental

This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: Bupropion (Drug)

CPT+ICSC

Experimental

This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: nicotine replacement therapy (NRT) (Drug)

CPT+ICSC

Experimental

This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: Integrated Care for Smoking Cessation (ICSC) (Behavioral)

CPT+ICSC

Experimental

This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: smokefreeVET (Behavioral)

ICSC only

Active Comparator

This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: Bupropion (Drug)

ICSC only

Active Comparator

This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: nicotine replacement therapy (NRT) (Drug)

ICSC only

Active Comparator

This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: Integrated Care for Smoking Cessation (ICSC) (Behavioral)

ICSC only

Active Comparator

This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.

干预措施: smokefreeVET (Behavioral)

结局指标

主要结局

Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up.

时间窗: 6-month follow-up

7-day point prevalence abstinence is defined as participant reporting no smoking occasions in the 7 days preceding the 6-month follow-up appointment. The 6-month follow-up occurs 6 months after the initial scheduled quit date.

Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million.

时间窗: 6-month follow-up

Self-reported 7-day point prevalence smoking abstinence was bioverified by breath carbon monoxide level of \< 4 parts per million at the 6-month follow-up.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

CPT and Smoking Cessation | 临床试验