Trauma-Informed Care for Smoking Cessation for Pregnancy

University of California San Francisco (UCSF)

Status: Enrolling

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

Treatments: Other: Expired carbon monoxide (CO); Other: Questionnaires; Other: Interviews

Study type: Interventional

Funder types: Other

Identifiers

NCT07129590

25634

NCI-2025-05151 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

This study is currently enrolling for Aim 1 only.

Study Objectives:

Aim 1: Assess barriers to successful maternal tobacco cessation for women with trauma and identify targets for intervention through interviewing pregnant women with trauma and clinicians in the safety-net using the Behavior Change Wheel (BCW), a validated implementation science behavior change framework.

Aim 2: Evaluate and adapt an evidence-based tobacco cessation intervention using the for pregnant women by incorporating trauma-informed approaches (the 4Rs) with the established 5As. Input will lead to the effective adaptation and creation of the final TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE) Pregnancy intervention to be tested in Aim 3.

Aim 3: Determine the feasibility and acceptability of the RISE Pregnancy intervention and protocol.

OUTLINE:

This study is currently enrolling for Aim 1 only.

Aim 1: Pregnant women in the safety-net who smoke and have histories of trauma, and clinicians will be interviewed using the BCW to assess barriers to smoking cessation and inform design of a smoking cessation intervention which will be used to inform the design of a smoking cessation intervention (RISE Pregnancy) for evaluation in Aim 2.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Clinician Eligibility Criteria (Aims 1 - 3):

In Aims 1-3, will be recruiting clinicians working in the Obstetrics, Midwifery, and Gynecology Clinic (5M) safety-net clinic and the UCSF Community and Clinical Research Center (ZSFG).

1. Nurse practitioner, physician assistant, nurse-midwife, or medical doctor caring for pregnant patient-participants.
2. Age ≥ 18 years old.

Patient-participant Eligibility Criteria (Aim 1):

In Aim 1, will be recruiting pregnant women receiving care at the 5M safety-net clinic who are actively smoking and have histories of trauma (ages 18+)

1. Currently smoking
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 from the 5M advisory boards will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.

Inclusion criteria:

1. Participant in a 5M Clinic Patient Advisory Board.
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 receiving care at the 5M safety-net clinic 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Aim 1: Development, Pilot Group

Experimental group

Description:

Both clinician- and patient-participants will participate in a 60-minute in-depth, semi-structured interview conducted either in-person or via secure University of California, San Francisco (UCSF) video-telephone software.

Treatment:

Other: Interviews

Other: Questionnaires

Other: Expired carbon monoxide (CO)