Smoking CessationNCT06357767
Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
A study testing Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence in people with Smoking Cessation and Cigarette Smoking, run by Black Hills Center for American Indian Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking Cessation, Cigarette Smoking
- What is being tested?
- Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
- 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
- 8 Aug 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Black Hills Center for American Indian Health
Rapid City, South Dakota, 57701
Jeffrey A. Henderson, MD, MPH, 605-348-6100, jhenderson@bhcaih.org
Jeffrey A. Henderson, MD, MPH
About this study
Official title: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
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.
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. Among women who have experienced IPV, post-traumatic stress disorder severity is related to nicotine dependence. Smoking prevalence among women who have experienced IPV is as high as 51% to 70%, which is two to three times greater than among women nationally. The high prevalence of smoking among women who have experienced IPV is a critical health concern because approximately one-third of U.S. women will experience IPV during their lifetime.
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. These high rates of smoking coupled with early age of initiation are accompanied by rising rates of mortality from cardiovascular disease and lung cancer, which are leading causes of death among this high risk group.
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. While smoking cessation approaches for American Indians typically address the differences of ceremonial versus commercial tobacco, such programs have not incorporated trauma-informed strategies-a framework that understands and responds to the impact of trauma by emphasizing physical, psychological, and emotional safety. Further, mindfulness-based approaches are shown to mitigate 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 trauma-informed and mindfulness 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, control, and safety. The physical health benefits to be experienced by American Indian women smokers upon quitting are significant. These include improvements in circulation and respiratory function, decreased risk of myocardial infarction and stroke, and decreased secondhand smoke exposure to family members. Additionally, the mental health benefits of a trauma-informed, mindfulness-based approach to interventions in general are clearly documented.
The 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, consistent with Stage 1a and 1b of the Stage Model of intervention development, the primary objective of this application is to finalize the 8-session novel intervention and examine its feasibility, acceptability, and satisfaction.
To achieve this goal, the following Specific and Technical Aims will be addressed:
Aim 1. Use a community-based participatory approach with a Community Advisory Board to refine intervention materials (including facilitator manual and training materials) and finalize pilot intervention methodology.
Aim 2. Conduct a single arm intervention trial enrolling 48 Northern Plains Tribal women smokers who have experienced IPV to examine: a) the primary study outcomes of feasibility, acceptability, and satisfaction with the culturally tailored, trauma-informed mindfulness smoking cessation intervention and b) 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.
Exploratory Aim. Concurrently, the investigators will explore 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 use.
Smoking cessation is among the most impactful behavior changes - it is effective in reducing morbidity and premature death. This project capitalizes on the Black Hills Center for American Indian Health's excellent and long-standing relationship with the Rapid City Indian Community, principally Lakota. Results will be among the very first evidence concerning smoking cessation efforts in this highly resilient though vulnerable and understudied population. Finally, this project's highly participatory approach will further strengthen tribal community partners' knowledge, expertise, and support for research conducted in a respectful and community-based framework. Findings will be used to inform a fully powered RCT to test this intervention in a Stage II trial.
- Conditions
- Smoking Cessation, Cigarette Smoking
- Being tested
- Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
- Medical subject headings
- Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner ViolenceBehavioural
A culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach.
| Study group | Role | What they receive |
|---|---|---|
| Healing Within | Experimental | A culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach. Receives: Behavioral: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trauma-Informed Practice Scales (TIPS)
Participants perception of cultural responsiveness of the intervention will be assessed using the 8-item Cultural Responsiveness and Inclusivity subscales of the TIPS as an index of intervention acceptability/likability. Items are rated on a 0-3 Likert scale, and mean scores are computed. Scores range from 0-3, with higher scores representing receipt of more trauma-informed, culturally responsive services.
Measured: Up to week 8
Session Rating Scale (SRS)
Participant ratings of working alliance will be assessed using the SRS as an index of intervention acceptability/likability. The SRS is a 4-item visual analog instrument. Each item is assessed using a 0-10 point scale. A total score is computed by summing each item. Scores will range from 0-60, with an overall score of 36, or 9 on any item, indicating potential concerns in working alliance.
Measured: Up to week 8
Group Attitude Scale (GAS)
Group cohesion will be assessed using a modified version of the GAS an an index of intervention acceptability/likability. The 20 items are rated on a 1-5 Likert scale. A total score is computed by averaging the items. Scores range from 1-5, with higher scores indicating more group cohesion.
Measured: Up to week 8
Secondary outcomes (6)
Biochemical verification of smoking status
Expired breath carbon monoxide will be measured using a carbon monoxide breath monitor. Carbon monoxide readings greater than 3ppm are indicative of smoking.
Measured: Baseline
Biochemical verification of smoking status
Expired breath carbon monoxide will be measured using a carbon monoxide breath monitor. Carbon monoxide readings greater than 3ppm are indicative of smoking.
Measured: End of treatment (approximately 8 weeks following baseline)
Biochemical verification of smoking status
Expired breath carbon monoxide will be measured using a carbon monoxide breath monitor. Carbon monoxide readings greater than 3ppm are indicative of smoking.
Measured: 3-months post treatment completion
Quit Attempts
Lifetime quit attempts of at least 24 hours will be assessed by self-report.
Measured: Baseline
Quit Attempts
Quit attempts of at least 24 hours will be assessed by self-report referencing the time since baseline.
Measured: End of treatment (approximately 8 weeks following baseline)
Quit Attempts
Quit attempts of at least 24 hours will be assessed by self-report referencing the time since the end-of-treatment follow-up interview.
Measured: 3-months post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start8 Aug 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jan 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.
- 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
- Lead sponsor
- Black Hills Center for American Indian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357767
- Sponsor's protocol ID
- S06GM146079
- Status last verified
- Aug 2024
- First submitted
- 16 Jan 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. 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
- NCT06357767
- Acronym / sponsor ID
- S06GM146079
- Conditions
- Smoking Cessation, Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Black Hills Center for American Indian HealthUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 10 Apr 2024 (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.
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.
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. Among women who have experienced IPV, post-traumatic stress disorder severity is related to nicotine dependence. Smoking prevalence among women who have experienced IPV is as high as 51% to 70%, which is two to three times greater than among women nationally. The high prevalence of smoking among women who have experienced IPV is a critical health concern because approximately one-third of U.S. women will experience IPV during their lifetime.
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. These high rates of smoking coupled with early age of initiation are accompanied by rising rates of mortality from cardiovascular disease and lung cancer, which are leading causes of death among this high risk group.
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. While smoking cessation approaches for American Indians typically address the differences of ceremonial versus commercial tobacco, such programs have not incorporated trauma-informed strategies-a framework that understands and responds to the impact of trauma by emphasizing physical, psychological, and emotional safety. Further, mindfulness-based approaches are shown to mitigate 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 trauma-informed and mindfulness 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, control, and safety. The physical health benefits to be experienced by American Indian women smokers upon quitting are significant. These include improvements in circulation and respiratory function, decreased risk of myocardial infarction and stroke, and decreased secondhand smoke exposure to family members. Additionally, the mental health benefits of a trauma-informed, mindfulness-based approach to interventions in general are clearly documented.
The 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, consistent with Stage 1a and 1b of the Stage Model of intervention development, the primary objective of this application is to finalize the 8-session novel intervention and examine its feasibility, acceptability, and satisfaction.
To achieve this goal, the following Specific and Technical Aims will be addressed:
Aim 1. Use a community-based participatory approach with a Community Advisory Board to refine intervention materials (including facilitator manual and training materials) and finalize pilot intervention methodology.
Aim 2. Conduct a single arm intervention trial enrolling 48 Northern Plains Tribal women smokers who have experienced IPV to examine: a) the primary study outcomes of feasibility, acceptability, and satisfaction with the culturally tailored, trauma-informed mindfulness smoking cessation intervention and b) 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.
Exploratory Aim. Concurrently, the investigators will explore 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 use.
Smoking cessation is among the most impactful behavior changes - it is effective in reducing morbidity and premature death. This project capitalizes on the Black Hills Center for American Indian Health's excellent and long-standing relationship with the Rapid City Indian Community, principally Lakota. Results will be among the very first evidence concerning smoking cessation efforts in this highly resilient though vulnerable and understudied population. Finally, this project's highly participatory approach will further strengthen tribal community partners' knowledge, expertise, and support for research conducted in a respectful and community-based framework. Findings will be used to inform a fully powered RCT to test this intervention in a Stage II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healing Within | Experimental | Behavioral: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner ViolenceA culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner ViolenceA culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach. | Behavioural | Healing Within |
Primary outcome
Trauma-Informed Practice Scales (TIPS)
Time frame: Up to week 8
Participants perception of cultural responsiveness of the intervention will be assessed using the 8-item Cultural Responsiveness and Inclusivity subscales of the TIPS as an index of intervention acceptability/likability. Items are rated on a 0-3 Likert scale, and mean scores are computed. Scores range from 0-3, with higher scores representing receipt of more trauma-informed, culturally responsive services.
Session Rating Scale (SRS)
Time frame: Up to week 8
Participant ratings of working alliance will be assessed using the SRS as an index of intervention acceptability/likability. The SRS is a 4-item visual analog instrument. Each item is assessed using a 0-10 point scale. A total score is computed by summing each item. Scores will range from 0-60, with an overall score of 36, or 9 on any item, indicating potential concerns in working alliance.
Group Attitude Scale (GAS)
Time frame: Up to week 8
Group cohesion will be assessed using a modified version of the GAS an an index of intervention acceptability/likability. The 20 items are rated on a 1-5 Likert scale. A total score is computed by averaging the items. Scores range from 1-5, with higher scores indicating more group cohesion.
6 secondary outcomes
Biochemical verification of smoking status
Time frame: Baseline
Biochemical verification of smoking status
Time frame: End of treatment (approximately 8 weeks following baseline)
Biochemical verification of smoking status
Time frame: 3-months post treatment completion
Quit Attempts
Time frame: Baseline
Quit Attempts
Time frame: End of treatment (approximately 8 weeks following baseline)
Quit Attempts
Time frame: 3-months post treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence in people with Smoking Cessation and Cigarette Smoking, run by Black Hills Center for American Indian Health 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Nez Henderson, MD ((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?
Trauma-Informed Practice Scales (TIPS) (time frame: Up to week 8). 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 12 Aug 2024.