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Smoking CessationNCT07013968

Healing Within: Mindfulness Smoking Cessation Intervention

A study testing culturally tailored, trauma-informed mindfulness smoking cessation intervention in people with Smoking Cessation, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
culturally tailored, trauma-informed mindfulness smoking cessation intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
25 Jan 2024to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patricia Nez Henderson, MD, MPH contact

605-348-6100

pnhenderson@bhcaih.org

Tami P Sullivan, PhD contact

203-789-7645

tami.sullivan@yale.edu

United States1 site, 1 recruiting
  • Black Hills Center for American Indian Health

    Rapid City, South Dakota, 57701

    Patricia Henderson, MD, MPH, 605-348-6100, pnhenderson@bhcaih.org

    Priscilla Nez, MS, 605-348-6100, panez@bhcaih.org

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

Cigarette smoking and intimate partner violence (IPV) are preventable, major public health concerns that result in severe physical and psychological consequences. Women who have experienced IPV are more likely to suffer from substance use, depression, anxiety, and post-traumatic stress disorder --all of which are risk factors for smoking. Smoking prevalence among women who have experienced IPV is as high as 51% to 70%. American Indian women, including Northern Plains Tribal women, experience the highest proportion of IPV among women from any racial/ethnic group. Furthermore, smoking prevalence among Northern Plains Tribal women is among the highest in the U.S. Specifically, among Northern Plains Tribal women who experienced IPV, 58% are current smokers. Multiple health interventions have been developed for women who have experienced IPV, including for alcohol and drug use given the high rates of these co-occurring problems. However, there have been no smoking cessation interventions among them. Trauma-informed, mindfulness-based approaches are shown to create physical, psychological, and emotional safety while mitigating habitual patterns of reactive or addictive behaviors by increasing awareness of reactivity and automated (e.g., smoking) behavior, allowing greater flexibility in response to cravings. These strength-based approaches are consistent with the values of American Indian culture and create opportunities for individuals who have been traumatized to rebuild a sense of choice and control. Our research team used an interactive, highly participatory approach to collect and use qualitative data to inform the initial development of a culturally tailored, trauma-informed smoking cessation intervention for Northern Plains Tribal women who have experienced IPV. Therefore, the primary objective of this application is to finalize the 8-session novel intervention and test its feasibility, acceptability, and satisfaction among a group of 48 Northern Plains Tribal women smokers who have experienced IPV. To achieve this goal, the following Aims will be addressed: 1) Use a community-based participatory approach with a Community Advisory Board to refine intervention materials and finalize the pilot intervention methodology; 2) Conduct a single arm intervention trial enrolling 48 Northern Plains Tribal women smokers who have experienced IPV to examine the primary study outcomes of feasibility, acceptability, and satisfaction with this culturally tailored, trauma-informed mindfulness smoking cessation intervention and the secondary study outcome of quit attempts and biochemically verified smoking abstinence prevalence at 3 and 6-months follow-up, which will gauge the effectiveness of the intervention; and 3) As an exploratory aim, the investigators will explore concurrent changes in drug and alcohol use given the proposed intervention's central focus on personal and historical trauma among American Indian women as contributors to addiction and consistent with a focus on poly- vs. single substance.

Being tested
culturally tailored, trauma-informed mindfulness smoking cessation intervention
Keywords
Trauma-informed, Culturally tailored
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • culturally tailored, trauma-informed mindfulness smoking cessation interventionBehavioural

    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.

Study groups in NCT07013968
Study groupRoleWhat they receive
48 Northern Plains Tribal women smokers who have experienced Intimate Partner Violence (IPV).ExperimentalThese participants will experience a culturally tailored, trauma-informed mindfulness smoking cessation intervention.
Receives: Behavioral: culturally tailored, trauma-informed mindfulness smoking cessation intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    How feasible are our methods

    Measured: 3 years

  2. Acceptability

    How acceptable are our Methods to our participants

    Measured: 3 years

  3. Satisfaction

    How satisfactory are our methods with our participants

    Measured: 3 years

Secondary outcomes (2)
  1. Quit attempts

    How many quit attempts did our participants make

    Measured: 3 years

  2. Biochemically-verified smoking abstinence

    Provide an estimate of this intervention's effectiveness

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start25 Jan 2024
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07013968
Sponsor's protocol ID
1 S06 GM146079-01-RP1
Other IDs
1S06GM146079-01
Status last verified
Aug 2025
First submitted
10 May 2023
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing culturally tailored, trauma-informed mindfulness smoking cessation intervention in people with Smoking Cessation, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patricia Nez Henderson, MD, MPH (605-348-6100, pnhenderson@bhcaih.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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