N/A
Completed N=22
Perinatal Attentional Retraining Intervention for Smoking for Minority Women
Postpartum Smoking Relapse
Source: ClinicalTrials.gov NCT04114877 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Attentional Bias- Smoking Related Stimuli — -44.0; 37.9 milliseconds — p=>0.05
Summary
The proposed research intends to randomize 50 abstinent pregnant Black or Hispanic smokers to receive either the attentional retraining (AR) or control VP task. Participants will be asked to carry around a smartphone as they go about their daily lives for 2 weeks in their last month of pregnancy (Phase 1).
The smartphone will sound an alert randomly during the day, at which time participants will be asked to respond to a short set of questions assessing subjective states; this will be followed by a request to complete the AR (or control) procedures. This same procedure will be repeated for 2 weeks immediately after delivery (Phase 2).
Women will undergo a follow-up visit 3 months after the end of Phase 2, and complete an unmodified VP and follow-up assessments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attentional Bias- Smoking Related Stimuli |
-44.0; 37.9 | >0.05 |
| PRIMARY Attentional Bias Toward Stressrelated Stimuli |
-12.1; -46.5 | >0.05 |
| SECONDARY Self-reported Craving |
1.35; 1.66 | >0.05 |
| SECONDARY Self-reported Stress |
3.34; 3.57 | >0.05 |
| SECONDARY Smoking Relapse |
4; 2 | 0.455 |
Eligibility Criteria
Inclusion Criteria
- Women with a history of smoking 5+ cigarettes per day that have achieved abstinence during pregnancy by 32 weeks gestation.
- The ability to speak and write English.
- An Edinburgh Postnatal Depression Scale (EPDS) score <10.
Exclusion Criteria
- Current substance abuse (e.g., alcohol, benzodiazepines, marijuana).
- Current major depressive disorder, minor depression or dysthymia, or history of any of these disorders in the last 6 months.
- The presence of an Axis I psychotic disorder.
- Plans to relocate out of the area.
- Imminent incarceration.
- Planned inpatient hospitalization during study period.
- Plans to breastfeed. Women who plan to breastfeed will be excluded since this is a powerful, independent motivation for remaining abstinent and may decrease the relapse event rate.
Data sourced from ClinicalTrials.gov (NCT04114877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.