Trial results for a study investigating a behavioral activation prenatal and postpartum intervention for depressed pregnant smokers were posted on ClinicalTrials.gov on 2026-02-05, with 26 participants enrolled.
Background
Depression during pregnancy can significantly impact maternal and fetal health, often complicating efforts to cease other harmful behaviors such as tobacco use. Tobacco use disorder in pregnant individuals poses substantial risks to both the mother and the developing fetus. Interventions that address both mental health conditions like depression and substance use disorders, specifically smoking cessation, are crucial for improving outcomes for this vulnerable population. This study aimed to evaluate a mood management and health and wellness smoking cessation intervention for depressed pregnant smokers during and after birth, with the goal of helping them quit smoking and maintain abstinence postpartum.
Trial design
This study, designated as Phase NA, enrolled 26 participants. It investigated conditions including Depression and Tobacco Use Disorder in pregnant smokers. The trial evaluated a mood management and health and wellness smoking cessation intervention. Participants were assigned to either a Health & Wellness group or a Behavioral Activation group, with the aim of assessing their impact during and after birth.
Key results
The trial results included several key measurements related to abstinence and depression scores across two different aims and groups:
- Abstinence (Participants):
- For "AIM 3: Assigned Health & Wellness (HW)", 2 participants achieved abstinence.
- For "Aim 3: Assigned Behavioral Activation", 1 participant achieved abstinence.
- For "AIM 4: Health & Wellness (HW)", 2 participants achieved abstinence.
- For "AIM 4: Behavioral Activation (BA)", 1 participant achieved abstinence.
- Depression (Scores on a Scale):
- For "AIM 3: Assigned Health & Wellness (HW)", the mean score was 2 (Standard Deviation 1.41).
- For "Aim 3: Assigned Behavioral Activation", the mean score was 7 (Standard Deviation 3.54).
- For "AIM 4: Health & Wellness (HW)", the mean score was 0.67 (Standard Deviation 1.15).
- For "AIM 4: Behavioral Activation (BA)", the mean score was 7.34 (Standard Deviation 10.21).
What this means
The posted results provide specific outcome measurements for abstinence and depression scores in pregnant smokers participating in a behavioral activation or health and wellness intervention. While the data presents raw counts for abstinence and mean scores with standard deviations for depression across different study aims and groups, no comparative analyses or statistical significance values were reported. These initial measurements contribute to the understanding of outcomes in this specific population, laying groundwork for potential future research into combined interventions for depression and tobacco use during pregnancy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05044546, titled "A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers", were posted on 2026-02-05 on clinicaltrials.gov.