Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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.

More Smoking Cessation trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment48 (estimated)
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
NIH
Locations1 site (Rapid City, South Dakota)
StatusRecruiting
StartedJanuary 25, 2024
Main results expectedJuly 31, 2026
Study endsAugust 31, 2026
Registry record updatedAugust 11, 2025
Trial IDNCT07013968 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.