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Trauma-Informed Care for Smoking Cessation for Pregnancy

a study on Smoking Cessation Tobacco Mental Health Psychological Trauma Trauma and Stressor Related Disorders

Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Anita Hargrave-Bouagnon, MD, MAS

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation, Smoking Reduction, Smoking, Cigarette, Trauma, Psychological, Trauma and Stressor Related Disorders, Pregnancy, Wounds and Injuries, Psychological Trauma, Carbon Monoxide, Expired carbon monoxide (CO), Interviews

Eligibility

You can join if…

Open to females ages 18 years and up

Clinician Eligibility Criteria (Aims 1 - 3):

In Aim 1-3, will be recruiting clinicians working in the Obstetrics, Midwifery, and Gynecology Clinic (5M) safety-net clinic.

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

Patient-participant Eligibility Criteria (Aims 1 & 3):

  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. Age ≥18 years old.
  3. Currently Pregnant.
  4. Identifies as a cisgender woman, or female at birth.
  5. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ).
  6. Proficient in English or Spanish languages.

Patient-Participant Eligibility Criteria (Aims 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.

You CAN'T join if...

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.

Location

  • Zuckerberg San Francisco General Hospital
    San Francisco California 94115 United States

Lead Scientist at UCSF

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07129590
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated