Trauma-informed smoking cessation support during pregnancy

TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)

This project will test a trauma-informed smoking cessation program that combines the 4Rs with the 5As to help pregnant women who smoke and have histories of trauma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07129590 on ClinicalTrials.gov

What this trial studies

Researchers partnered with Breathe California and a San Francisco public safety-net clinic to design a smoking cessation approach tailored for pregnant women with trauma histories. In Aim 1 they are interviewing pregnant patients and clinic clinicians using the Behavior Change Wheel to identify barriers and targets for change. Input from Aim 1 will be used to adapt the evidence-based 5As tobacco cessation approach by embedding the trauma-informed 4Rs, producing the RISE Pregnancy intervention. Subsequent aims will pilot the adapted intervention and measure feasibility and acceptability before broader testing.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18 or older who currently smoke (or smoked in a prior pregnancy), identify as female or female at birth, report a trauma exposure by DSM-5 criteria, and are proficient in English or Spanish and receive care in the participating safety-net clinic.

Not a fit: People who are not pregnant, do not smoke, do not have a trauma history, are not English- or Spanish-proficient, or cannot access the participating San Francisco safety-net clinics are unlikely to benefit from this specific program.

Why it matters

Potential benefit: If successful, the adapted trauma-informed program could increase quit rates and improve prenatal outcomes by providing tailored, non retraumatizing support for pregnant women who smoke.

How similar studies have performed: Trauma-informed approaches have supported recovery in other substance use disorders and the 5As are evidence-based for tobacco cessation, but combining the 4Rs with the 5As specifically for pregnant women with trauma is a novel adaptation that has not yet been proven.

Eligibility criteria

Inclusion Criteria:

Clinician Eligibility Criteria (Aims 1 - 3):

In Aims 1-3, will be recruiting clinicians working in our clinic sites.

1. 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.
2. Age ≥ 18 years old.

Patient-participant Eligibility Criteria (Aim 1):

In Aim 1, will be recruiting pregnant women (ages 18+) who:

1. Currently smoking or report having smoked during a previous pregnancy
2. Age ≥18 years old.
3. Currently Pregnant.
4. Identifies as a cisgender woman, or female at birth.
5. Reports having experienced trauma aligned with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition for traumatic exposure.
6. 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:

1. Current or former patient in the participating clinical sites.
2. Age ≥18 years old.
3. 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:

1. 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)
2. ≥18 years old
3. Currently Pregnant
4. Identifies as a cisgender women, or female at birth
5. Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ)
6. English or Spanish Proficient

Exclusion Criteria:

Clinician- and Patient-participant Exclusion criteria (Aims 1 - 3):

1\. 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 this trial is running

San Francisco, California

• Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Anita Hargrave-Bouagnon, MD, MAS — University of California, San Francisco
• Study coordinator: Gaby Luna-Victoria, MD, MAS

Conditions Smoking Cessation; Tobacco Smoking; Tobacco Use Cessation; Smoking Reduction; Smoking, Cigarette; Trauma, Psychological; Trauma and Stressor Related Disorders; Pregnancy