Mindfulness smoking cessation for Northern Plains Tribal women affected by intimate partner violence
Official title: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
Run by National Heart, Lung, and Blood Institute (NHLBI) · NCT07013968 · Data updated 2026-11-12
This program will try a culturally tailored, trauma-informed mindfulness approach to help Northern Plains Tribal women who smoke and have experienced intimate partner violence quit smoking.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 48 (estimated) |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) NIH |
| Locations | 1 site (Rapid City, South Dakota) |
| Status | Recruiting |
| Started | January 25, 2024 |
| Main results expected | July 31, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | August 11, 2025 |
| Trial ID | NCT07013968 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) who are Northern Plains Tribal women, smoke at least five cigarettes per day, have experienced physical or psychological intimate partner violence, can provide informed consent, and can remain in the region for six months are ideal candidates.
✕Probably not a fit
People under 18, those who plan to move away within six months, cannot give informed consent, or who smoke fewer than five cigarettes per day may not receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Using a highly participatory approach with Northern Plains Tribal community members, the intervention delivers a culturally tailored, trauma-informed mindfulness curriculum aimed at reducing cigarette use among women with a history of intimate partner violence. Eligible adults who smoke at least five cigarettes per day and report physical or psychological IPV will be invited to participate at the Black Hills Center for American Indian Health in Rapid City, South Dakota. The study will measure feasibility, acceptability, and participant satisfaction and collect smoking-related outcomes over a follow-up period to inform adaptation for other Tribal communities. The curriculum emphasizes safety, emotional regulation, and awareness of habitual responses to cravings to support behavior change.
Why it matters
Potential benefit: If successful, participants could experience reduced smoking, improved coping with trauma-related triggers, and a culturally congruent program that other Tribes can adapt.
How similar studies have gone: Mindfulness and trauma-informed approaches have shown promise for reducing addictive and reactive behaviors, but smoking cessation programs specifically tailored for IPV-exposed Northern Plains Tribal women are novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Black Hills Center for American Indian Health
Rapid City, South Dakota, United States Recruiting
Study contacts
- Principal investigator: Patricia Nez Henderson, MD, MPH — Black Hills Center for American Indian Health
- Study coordinator: Patricia Nez Henderson, MD, MPH
- Email: pnhenderson@bhcaih.org
- Phone: 605-348-6100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.