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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Smoking Cessation
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
Feasibility
How feasible are our methods
Measured: 3 years
Acceptability
How acceptable are our Methods to our participants
Measured: 3 years
Satisfaction
How satisfactory are our methods with our participants
Measured: 3 years
Secondary outcomes (2)
Quit attempts
How many quit attempts did our participants make
Measured: 3 years
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.
- First posted10 Jun 2025
- Study start25 Jan 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Jeffrey A Henderson, MD, MPH, Black Hills Center for American Indian Health
- Investigators
- Patricia Nez Henderson, MD, MPH, Principal investigator, Black Hills Center for American Indian Health
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT07013968
- Acronym / sponsor ID
- 1 S06 GM146079-01-RP1
- Conditions
- Smoking Cessation
- Keywords
- Trauma-informed, Culturally tailored
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Yale University
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 48 Northern Plains Tribal women smokers who have experienced Intimate Partner Violence (IPV). | Experimental | Behavioral: culturally tailored, trauma-informed mindfulness smoking cessation interventionThese participants will experience a culturally tailored, trauma-informed mindfulness smoking cessation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Report smoking ≥ 5 cigarettes per day
- A victim of physical and/or psychological IPV
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- < 18 years of age
- Plans on moving out of the region in the next six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| culturally tailored, trauma-informed mindfulness smoking cessation interventionEight 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. | Behavioural | 48 Northern Plains Tribal women smokers who have experienced Intimate Partner Violence (IPV). |
Primary outcome
Feasibility
Time frame: 3 years
How feasible are our methods
Acceptability
Time frame: 3 years
How acceptable are our Methods to our participants
Satisfaction
Time frame: 3 years
How satisfactory are our methods with our participants
2 secondary outcomes
Quit attempts
Time frame: 3 years
Biochemically-verified smoking abstinence
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Nez Henderson, MD, MPH principal investigator
Black Hills Center for American Indian Health
1 site in 1 country: see every site and its status.
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.