Recruiting

Smoking Cessation

Sponsor:

Black Hills Center for American Indian Health

Code:

NCT06357767

Conditions

Smoking Cessation

Cigarette Smoking

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence

Study Details

Brief summary:

The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate partner violence (IPV). The primary aims of this study are to: (a) use a community-based participatory approach to refine intervention materials and finalize pilot intervention methodology for a culturally tailored, trauma-informed smoking cessation intervention for AI women who have experienced IPV; (b) examine feasibility, acceptability, satisfaction, and preliminary efficacy of the intervention; and (c) explore changes in alcohol and drug use over the course of the intervention.

Participants will be asked to participate in the 8-week Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, and complete interviews at baseline, end-of-treatment, and three months from the end of treatment.

Conditions

Smoking Cessation

Cigarette Smoking

Study ID

NCT06357767

Start date

Aug 8, 2024

Status verified date

Aug, 2024

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • American Indian woman from the Northern Plains
  • Live in Rapid City, SD or surrounding area
  • Willing to quit smoking during study participation
  • 18 years of age or older
  • Smoking at least five cigarettes per day
  • Experienced physical and/or psychological IPV in the past three months

Exclusion Criteria:

  • Inability to give consent and/or adequately complete questionnaires due to cognitive impairment.
  • Self-reported pregnancy or intention to become pregnant during the intervention period

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Healing Within

A culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach.

Interventions

Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence

A culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach.

Primary outcome measure

  • Trauma-Informed Practice Scales (TIPS) [ Time Frame: Up to week 8 ]
  • Session Rating Scale (SRS) [ Time Frame: Up to week 8 ]
  • Group Attitude Scale (GAS) [ Time Frame: Up to week 8 ]

Central Contacts and Locations

Central contacts

Patricia Nez Henderson, MD

(605) 348-6100pnhenderson@bhcaih.org

Locations

Black Hills Center for American Indian Health

Recruiting

Rapid City, South Dakota, United States, 57701

Contacts

Jeffrey A. Henderson, MD, MPH

605-348-6100jhenderson@bhcaih.org

Principal Investigator:

Jeffrey A. Henderson, MD, MPH

More Information

Sponsor

Black Hills Center for American Indian Health

Last update posted

Aug 12, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Black Hills Center for American Indian Health on 2024-08-12.