Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357767
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-01-16
Brief Title:
Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
Sponsor:
Black Hills Center for American Indian Health
Organization:
Black Hills Center for American Indian Health
Study Overview
Official Title:
Healing Within Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 US 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 racialethnic group Furthermore smoking prevalence among Northern Plains Tribal women is among the highest in the US 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 eg 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
Aim 1 Use a community-based participatory approach with a Community Advisory Board to refine intervention materials including facilitator manual and training materials and finalize pilot intervention methodology
Aim 2 Conduct a single arm intervention trial enrolling 48 Northern Plains Tribal women smokers who have experienced IPV to examine a the primary study outcomes of feasibility acceptability and satisfaction with the culturally tailored trauma-informed mindfulness smoking cessation intervention and b 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
Exploratory Aim Concurrently the investigators will explore changes in drug and alcohol use given the proposed interventions 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 use
Smoking cessation is among the most impactful behavior changes - it is effective in reducing morbidity and premature death This project capitalizes on the Black Hills Center for American Indian Healths excellent and long-standing relationship with the Rapid City Indian Community principally Lakota Results will be among the very first evidence concerning smoking cessation efforts in this highly resilient though vulnerable and understudied population Finally this projects highly participatory approach will further strengthen tribal community partners knowledge expertise and support for research conducted in a respectful and community-based framework Findings will be used to inform a fully powered RCT to test this intervention in a Stage II trial
American Indian women including Northern Plains Tribal women experience the highest proportion of IPV among women from any racialethnic group Furthermore smoking prevalence among Northern Plains Tribal women is among the highest in the US 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 eg 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
Aim 1 Use a community-based participatory approach with a Community Advisory Board to refine intervention materials including facilitator manual and training materials and finalize pilot intervention methodology
Aim 2 Conduct a single arm intervention trial enrolling 48 Northern Plains Tribal women smokers who have experienced IPV to examine a the primary study outcomes of feasibility acceptability and satisfaction with the culturally tailored trauma-informed mindfulness smoking cessation intervention and b 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
Exploratory Aim Concurrently the investigators will explore changes in drug and alcohol use given the proposed interventions 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 use
Smoking cessation is among the most impactful behavior changes - it is effective in reducing morbidity and premature death This project capitalizes on the Black Hills Center for American Indian Healths excellent and long-standing relationship with the Rapid City Indian Community principally Lakota Results will be among the very first evidence concerning smoking cessation efforts in this highly resilient though vulnerable and understudied population Finally this projects highly participatory approach will further strengthen tribal community partners knowledge expertise and support for research conducted in a respectful and community-based framework Findings will be used to inform a fully powered RCT to test this intervention in a Stage II trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None