Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Session Rating Scale (SRS)
研究概览
简要总结
The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate partner violence (IPV). The primary aims of this study are to: (a) use a community-based participatory approach to refine intervention materials and finalize pilot intervention methodology for a culturally tailored, trauma-informed smoking cessation intervention for AI women who have experienced IPV; (b) examine feasibility, acceptability, satisfaction, and preliminary efficacy of the intervention; and (c) explore changes in alcohol and drug use over the course of the intervention.
Participants will be asked to participate in the 8-week Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, and complete interviews at baseline, end-of-treatment, and three months from the end of treatment.
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. Among women who have experienced IPV, post-traumatic stress disorder severity is related to nicotine dependence. Smoking prevalence among women who have experienced IPV is as high as 51% to 70%, which is two to three times greater than among women nationally. The high prevalence of smoking among women who have experienced IPV is a critical health concern because approximately one-third of U.S. women will experience IPV during their lifetime.
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. These high rates of smoking coupled with early age of initiation are accompanied by rising rates of mortality from cardiovascular disease and lung cancer, which are leading causes of death among this high risk group.
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. While smoking cessation approaches for American Indians typically address the differences of ceremonial versus commercial tobacco, such programs have not incorporated trauma-informed strategies-a framework that understands and responds to the impact of trauma by emphasizing physical, psychological, and emotional safety. Further, mindfulness-based approaches are shown to mitigate 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 trauma-informed and mindfulness 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, control, and safety. The physical health benefits to be experienced by American Indian women smokers upon quitting are significant. These include improvements in circulation and respiratory function, decreased risk of myocardial infarction and stroke, and decreased secondhand smoke exposure to family members. Additionally, the mental health benefits of a trauma-informed, mindfulness-based approach to interventions in general are clearly documented.
The 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, consistent with Stage 1a and 1b of the Stage Model of intervention development, the primary objective of this application is to finalize the 8-session novel intervention and examine its feasibility, acceptability, and satisfaction.
To achieve this goal, the following Specific and Technical Aims will be addressed:
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
- 否
入选标准
- •American Indian woman from the Northern Plains
- •Live in Rapid City, SD or surrounding area
- •Willing to quit smoking during study participation
- •18 years of age or older
- •Smoking at least five cigarettes per day
- •Experienced physical and/or psychological IPV in the past three months
排除标准
- •Inability to give consent and/or adequately complete questionnaires due to cognitive impairment.
- •Self-reported pregnancy or intention to become pregnant during the intervention period
结局指标
主要结局
Session Rating Scale (SRS)
时间窗: Up to week 8
Participant ratings of working alliance will be assessed using the SRS as an index of intervention acceptability/likability. The SRS is a 4-item visual analog instrument. Each item is assessed using a 0-10 point scale. A total score is computed by summing each item. Scores will range from 0-60, with an overall score of 36, or 9 on any item, indicating potential concerns in working alliance.
Group Attitude Scale (GAS)
时间窗: Up to week 8
Group cohesion will be assessed using a modified version of the GAS an an index of intervention acceptability/likability. The 20 items are rated on a 1-5 Likert scale. A total score is computed by averaging the items. Scores range from 1-5, with higher scores indicating more group cohesion.
Trauma-Informed Practice Scales (TIPS)
时间窗: Up to week 8
Participants perception of cultural responsiveness of the intervention will be assessed using the 8-item Cultural Responsiveness and Inclusivity subscales of the TIPS as an index of intervention acceptability/likability. Items are rated on a 0-3 Likert scale, and mean scores are computed. Scores range from 0-3, with higher scores representing receipt of more trauma-informed, culturally responsive services.
次要结局
- Biochemical verification of smoking status(3-months post treatment completion)
- Quit Attempts(3-months post treatment completion)
