NCT07013968

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Jan 2024Aug 2026

First Submitted

Initial submission to the registry

May 10, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

January 25, 2024

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

May 10, 2023

Last Update Submit

August 5, 2025

Conditions

Smoking Cessation

Keywords

Trauma-informedCulturally tailored

Outcome Measures

Primary Outcomes (3)

  • Feasibility

    How feasible are our methods

    3 years

  • Acceptability

    How acceptable are our Methods to our participants

    3 years

  • Satisfaction

    How satisfactory are our methods with our participants

    3 years

Secondary Outcomes (2)

  • Quit attempts

    3 years

  • Biochemically-verified smoking abstinence

    3 years

Study Arms (1)

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

EXPERIMENTAL

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

Behavioral: culturally tailored, trauma-informed mindfulness smoking cessation intervention

Interventions

culturally tailored, trauma-informed mindfulness smoking cessation interventionBEHAVIORAL

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.

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Hills Center for American Indian Health

Rapid City, South Dakota, 57701, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Patricia Nez Henderson, MD, MPH

    Black Hills Center for American Indian Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Nez Henderson, MD, MPH

CONTACT

605-348-6100pnhenderson@bhcaih.org

Tami P Sullivan, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI/Program Director

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 10, 2025

Study Start

January 25, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)