跳至主要内容
临床试验/NCT07013968
NCT07013968招募中不适用

Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence

National Heart, Lung, and Blood Institute (NHLBI)1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Acceptability

研究概览

简要总结

Using a highly participatory approach, this study will assess the feasibility, acceptability, and satisfaction with a culturally tailored, trauma-informed smoking cessation intervention for Northern Plains Tribal women who have experienced intimate partner violence. If successful, other American Indian Tribes and Tribal communities can adapt this innovative smoking cessation curriculum for their communities.

详细描述

Cigarette smoking and intimate partner violence (IPV) are preventable, major public health concerns that result in severe physical and psychological consequences. Women who have experienced IPV are more likely to suffer from substance use, depression, anxiety, and post-traumatic stress disorder --all of which are risk factors for smoking. Smoking prevalence among women who have experienced IPV is as high as 51% to 70%. American Indian women, including Northern Plains Tribal women, experience the highest proportion of IPV among women from any racial/ethnic group. Furthermore, smoking prevalence among Northern Plains Tribal women is among the highest in the U.S. Specifically, among Northern Plains Tribal women who experienced IPV, 58% are current smokers. Multiple health interventions have been developed for women who have experienced IPV, including for alcohol and drug use given the high rates of these co-occurring problems. However, there have been no smoking cessation interventions among them. Trauma-informed, mindfulness-based approaches are shown to create physical, psychological, and emotional safety while mitigating habitual patterns of reactive or addictive behaviors by increasing awareness of reactivity and automated (e.g., smoking) behavior, allowing greater flexibility in response to cravings. These strength-based approaches are consistent with the values of American Indian culture and create opportunities for individuals who have been traumatized to rebuild a sense of choice and control. Our research team used an interactive, highly participatory approach to collect and use qualitative data to inform the initial development of a culturally tailored, trauma-informed smoking cessation intervention for Northern Plains Tribal women who have experienced IPV. Therefore, the primary objective of this application is to finalize the 8-session novel intervention and test its feasibility, acceptability, and satisfaction among a group of 48 Northern Plains Tribal women smokers who have experienced IPV. To achieve this goal, the following Aims will be addressed: 1) Use a community-based participatory approach with a Community Advisory Board to refine intervention materials and finalize the pilot intervention methodology; 2) Conduct a single arm intervention trial enrolling 48 Northern Plains Tribal women smokers who have experienced IPV to examine the primary study outcomes of feasibility, acceptability, and satisfaction with this culturally tailored, trauma-informed mindfulness smoking cessation intervention and the secondary study outcome of quit attempts and biochemically verified smoking abstinence prevalence at 3 and 6-months follow-up, which will gauge the effectiveness of the intervention; and 3) As an exploratory aim, the investigators will explore concurrent changes in drug and alcohol use given the proposed intervention's central focus on personal and historical trauma among American Indian women as contributors to addiction and consistent with a focus on poly- vs. single substance.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •≥ 18 years of age
  • •Report smoking ≥ 5 cigarettes per day
  • •A victim of physical and/or psychological IPV

排除标准

  • •Unable to provide informed consent
  • •< 18 years of age
  • •Plans on moving out of the region in the next six months

研究组 & 干预措施

48 Northern Plains Tribal women smokers who have experienced Intimate Partner Violence (IPV).

Experimental

These participants will experience a culturally tailored, trauma-informed mindfulness smoking cessation intervention.

干预措施: culturally tailored, trauma-informed mindfulness smoking cessation intervention (Behavioral)

结局指标

主要结局

Acceptability

时间窗: 3 years

How acceptable are our Methods to our participants

Feasibility

时间窗: 3 years

How feasible are our methods

Satisfaction

时间窗: 3 years

How satisfactory are our methods with our participants

次要结局

  • Quit attempts(3 years)
  • Biochemically-verified smoking abstinence(3 years)

研究者

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

Jeffrey A Henderson, MD, MPH

PI/Program Director

Black Hills Center for American Indian Health

研究点 (1)

Loading locations...

相似试验