Clinical trial NCT07013968: Healing Within: Mindfulness Smoking Cessation Intervention
Official title: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Trauma-informed
Culturally tailored
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: Yale University
First posted: 2025-06-10
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility
timeFrame: 3 years
measure: Acceptability
timeFrame: 3 years
measure: Satisfaction
timeFrame: 3 years
Secondary outcomes:
measure: Quit attempts
timeFrame: 3 years
measure: Biochemically-verified smoking abstinence
timeFrame: 3 years
Other outcomes:
Locations:
city: Rapid City
country: United States
facility: Black Hills Center for American Indian Health
state: South Dakota
Study officials:
affiliation: Black Hills Center for American Indian Health
name: Patricia Nez Henderson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: