Recruiting

Smoking Cessation

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT07013968

Conditions

Smoking Cessation

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

culturally tailored, trauma-informed mindfulness smoking cessation intervention

Study Details

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.

Conditions

Smoking Cessation

Study ID

NCT07013968

Start date

Jan 25, 2024

Status verified date

Aug, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 48 Northern Plains Tribal women smokers who have experienced Intimate Partner Violence (IPV).

These participants will experience a culturally tailored, trauma-informed mindfulness smoking cessation intervention.

Interventions

culturally tailored, trauma-informed mindfulness smoking cessation intervention

Eight weekly in-person group sessions, each 90 minutes long. From the second half of PY01 to PY04, sessions will be performed in closed in groups of 7-10 participants (with a total of 6 groups). The curriculum is grounded in Lakota values and trauma-informed care. Each of the eight sessions will begin and end with a Lakota serenity prayer and "wazílya" (smudging of sage), and the meaning and relevance of one of the Lakota values will be discussed. Through a storytelling approach, which is central to Lakota culture, the participants will learn about their value as a Lakota woman, the role of caŋṡaṡa, the association between unresolved trauma and smoking, and the importance of Lakota mind-based and mindfulness strategies in their lives.

Primary outcome measure

  • Feasibility [ Time Frame: 3 years ]
  • Acceptability [ Time Frame: 3 years ]
  • Satisfaction [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Patricia Nez Henderson, MD, MPH

605-348-6100pnhenderson@bhcaih.org

Tami P Sullivan, PhD

203-789-7645tami.sullivan@yale.edu

Locations

Black Hills Center for American Indian Health

Recruiting

Rapid City, South Dakota, United States, 57701

Contacts

Patricia Henderson, MD, MPH

605-348-6100pnhenderson@bhcaih.org

Priscilla Nez, MS

605-348-6100panez@bhcaih.org

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

  • Trauma-informed
  • Culturally tailored

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2025-08-11.