Trauma-Informed Care for Smoking Cessation for Pregnancy
Recruiting now · Not applicable
Conditions studied: Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation, Smoking Reduction, Smoking, Cigarette, Trauma, Psychological, Trauma and Stressor Related Disorders
In brief
Trauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) Realizing the prevalence of trauma and pathways to recovery, (2) Recognizing symptoms of trauma, (3) Responding by embedding knowledge of trauma into practices and policies and (4) Resisting re-traumatization (the 4Rs). In close partnership with Breathe California and a public safety-net clinic in San Francisco that serves primarily racial and ethnic minoritized (REM) pregnant women, the 4Rs along with the Ask, Advise, Assess, Assist and Arrange (the 5As) evidence-based intervention for tobacco cessation that is delivered by health care professionals and is a US Public Health Services clinical practice guideline for treating tobacco will be used to create and implement a smoking cessation intervention for pregnant women with experiences of trauma.
Key facts
- Study ID
- NCT07129590
- Run by
- University of California, San Francisco
- People needed
- 20
- Starts
- 2025-11-19
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Clinician Eligibility Criteria (Aims 1 - 3):
- In Aims 1-3, will be recruiting clinicians working in our clinic sites.
- Nurse practitioner, physician assistant, nurse-midwife, medical doctor, registered nurse, clinical pharmacist, behavioral health professional, social worker, or any other healthcare professional caring for pregnant patient-participants.
- Age ≥ 18 years old.
- Patient-participant Eligibility Criteria (Aim 1):
- In Aim 1, will be recruiting pregnant women (ages 18+) who:
- Currently smoking or report having smoked during a previous pregnancy
- Age ≥18 years old.
- Currently Pregnant.
- Identifies as a cisgender woman, or female at birth.
- Reports having experienced trauma aligned with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition for traumatic exposure.
- Proficient in English or Spanish languages.
- Patient-Participant Eligibility Criteria (Aim 2):
- Patient-participants will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.
- Inclusion criteria:
- Current or former patient in the participating clinical sites.
- Age ≥18 years old.
- Proficient in English or Spanish languages.
- Patient-Participant Eligibility Criteria (Aim 3): In Aim 3, will be recruiting pregnant women who are actively smoking and have histories of trauma (ages 18+).
- Inclusion criteria:
- Currently smoking (ever smoked 100 cigarettes in their lifetime, smoked in the past 7 days and at least 1 cigarette per day, verified by CO≥6ppm)
- ≥18 years old
- Currently Pregnant
- Identifies as a cisgender women, or female at birth
- Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ)
You may not qualify if…
- Clinician- and Patient-participant Exclusion criteria (Aims 1 - 3):
- Any condition, including active mental health crises or cognitive impairment, that would interfere with the ability to provide informed consent or safely complete the study.
Where it is running
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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