Healing Within: Mindfulness Smoking Cessation Intervention
Part of paid clinical trials in Rapid City, South Dakota.
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Study ID
- NCT07013968
- Status
- Recruiting
Conditions
- Smoking Cessation
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- culturally tailored, trauma-informed mindfulness smoking cessation intervention — BEHAVIORALEight 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.
Study Details
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.
Key Dates
- Start date
- Jan 25, 2024
- Status verified
- Aug 2025
- Primary completion
- Jul 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
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.
Primary Outcome Measure
Feasibility [ Time Frame: 3 years ]
Central Contacts
- Patricia Nez Henderson, MD, MPH605-348-6100
- Tami P Sullivan, PhD203-789-7645
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Black Hills Center for American Indian Health | Rapid City | South Dakota | 57701 |
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