Trial Outcomes & Findings for A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers (NCT NCT05044546)
NCT ID: NCT05044546
Last Updated: 2026-02-05
Results Overview
Point-prevalence abstinence at last treatment visit at 10 weeks or earlier if ppt was lost to follow up defined as both a self-report of not smoking during the previous 7 days and a negative result from biochemical verification.
ACTIVE_NOT_RECRUITING
NA
26 participants
Last treatment visit at 10 weeks or earlier if participant was lost to follow up
2026-02-05
Participant Flow
Participant milestones
| Measure |
AIM 1: Qualitative Focus Groups/Individual Interviews
Qualitative group/individual interviews to refine delivery of BA and HW therapy conditions via smartphone
|
Aim 3: Assigned HW Control
10 week treatment course of Health and Wellness Educational Therapy (Control Condition) delivered via smartphone videoconferencing
|
Aim 3: Assigned BA Treatment
10 week treatment course of Behavioral Activation therapy (Treatment Condition) delivered via smartphone videoconferencing
|
Aim 4: Health and Wellness (HW)
Standard smoking cessation counseling plus HW, a didactic health education counseling on ways women can physically care for themselves during pregnancy and postpartum.
|
Aim 4: Behavioral Activation (BA)
Standard smoking cessation counseling plus BA, which focuses on increasing rewarding and adaptive behaviors and decreasing avoidance and withdrawal.
|
|---|---|---|---|---|---|
|
Aim 1
STARTED
|
11
|
0
|
0
|
0
|
0
|
|
Aim 1
COMPLETED
|
11
|
0
|
0
|
0
|
0
|
|
Aim 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
AIM 3 Pilot Study
STARTED
|
0
|
3
|
6
|
0
|
0
|
|
AIM 3 Pilot Study
COMPLETED
|
0
|
3
|
5
|
0
|
0
|
|
AIM 3 Pilot Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
|
AIM 4: Randomized Trial
STARTED
|
0
|
0
|
0
|
3
|
3
|
|
AIM 4: Randomized Trial
COMPLETED
|
0
|
0
|
0
|
3
|
3
|
|
AIM 4: Randomized Trial
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
AIM 1: Qualitative Focus Groups/Individual Interviews
Qualitative group/individual interviews to refine delivery of BA and HW therapy conditions via smartphone
|
Aim 3: Assigned HW Control
10 week treatment course of Health and Wellness Educational Therapy (Control Condition) delivered via smartphone videoconferencing
|
Aim 3: Assigned BA Treatment
10 week treatment course of Behavioral Activation therapy (Treatment Condition) delivered via smartphone videoconferencing
|
Aim 4: Health and Wellness (HW)
Standard smoking cessation counseling plus HW, a didactic health education counseling on ways women can physically care for themselves during pregnancy and postpartum.
|
Aim 4: Behavioral Activation (BA)
Standard smoking cessation counseling plus BA, which focuses on increasing rewarding and adaptive behaviors and decreasing avoidance and withdrawal.
|
|---|---|---|---|---|---|
|
AIM 3 Pilot Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
Baseline characteristics by cohort
| Measure |
AIM 3: Women Assigned to Behavioral Activation (BA)
n=6 Participants
10 week treatment course of Behavioral Activation Treatment Condition delivered via smartphone videoconferencing
|
AIM 4: Health & Wellness (HW)
n=3 Participants
Standard smoking cessation counseling plus HW, a didactic health education counseling on ways women can physically care for themselves during pregnancy and postpartum.
|
AIM 4: Behavioral Activation (BA)
n=3 Participants
Standard smoking cessation counseling plus HW, a didactic health education counseling on ways women can physically care for themselves during pregnancy and postpartum.
|
Total
n=26 Participants
Total of all reporting groups
|
AIM 3: Women Assigned to Health & Wellness (HW)
n=3 Participants
10 week treatment course of Health and Wellness Educational Therapy (Control Condition) delivered via smartphone videoconferencing
|
AIM 1: Focus Groups
n=11 Participants
Qualitative group/individual interviews to refine delivery of BA and HW therapy conditions via smartphone
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
3 Participants
|
26 Participants
n=140 Participants
|
3 Participants
n=1581 Participants
|
11 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=4626 Participants
|
3 Participants
n=72 Participants
|
3 Participants
|
26 Participants
n=140 Participants
|
3 Participants
n=1581 Participants
|
11 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
1 Participants
|
4 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
2 Participants
|
22 Participants
n=140 Participants
|
3 Participants
n=1581 Participants
|
10 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
1 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
1 Participants
|
14 Participants
n=140 Participants
|
1 Participants
n=1581 Participants
|
8 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
1 Participants
|
8 Participants
n=140 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
|
3 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=4626 Participants
|
3 participants
n=72 Participants
|
3 participants
|
26 participants
n=140 Participants
|
3 participants
n=1581 Participants
|
11 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Last treatment visit at 10 weeks or earlier if participant was lost to follow upPopulation: Analysis was not a part of AIM 1.
Point-prevalence abstinence at last treatment visit at 10 weeks or earlier if ppt was lost to follow up defined as both a self-report of not smoking during the previous 7 days and a negative result from biochemical verification.
Outcome measures
| Measure |
AIM 3: Assigned Health & Wellness (HW)
n=3 Participants
Standard smoking cessation counseling plus HW, a didactic health education counseling on ways women can physically care for themselves during pregnancy and postpartum.
|
Aim 3: Assigned Behavioral Activation
n=6 Participants
Standard smoking cessation counseling plus BA, which focuses on increasing rewarding and adaptive behaviors and decreasing avoidance and withdrawal
|
|---|---|---|
|
Abstinence
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Last treatment visit at 10 weeks or eariler if participant was lost to follow upPopulation: Analysis was not a part of AIM 1.
Depression as assessed using the Patient Health Questionnaire (PHQ-9) measure. The PHQ 9 is the major depressive episode scale from the Patient Health Questionnaire (PHQ). There are nine items on the Patient Health Questionnaire (PHQ-9). The PHQ-9 Depression Severity score is calculated by assigning score of 0, 1, 2, 3 to the response category of "not at all", "several days", "more than half, the days", and "nearly every day", respectively. The PHQ-9 total score for the nine items ranges from 0 to 27. The higher the value indicates a more severe score. The total score is a combination of the number of total symptoms experienced and the frequency of those symptoms over a two week period. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. There are no subscales on the PHQ-9
Outcome measures
| Measure |
AIM 3: Assigned Health & Wellness (HW)
n=3 Participants
Standard smoking cessation counseling plus HW, a didactic health education counseling on ways women can physically care for themselves during pregnancy and postpartum.
|
Aim 3: Assigned Behavioral Activation
n=6 Participants
Standard smoking cessation counseling plus BA, which focuses on increasing rewarding and adaptive behaviors and decreasing avoidance and withdrawal
|
|---|---|---|
|
Depression
|
2 Scores on a Scale
Standard Deviation 1.41
|
7 Scores on a Scale
Standard Deviation 3.54
|
PRIMARY outcome
Timeframe: 4 ½ months postpartumPopulation: Analysis was not a part of AIM 1 \& AIM 3 for this outcome measure.
Point-prevalence abstinence at 4 ½ months postpartum follow-ups defined as both a self-report of not smoking during the previous 7 days and a negative result from biochemical verification.
Outcome measures
| Measure |
AIM 3: Assigned Health & Wellness (HW)
n=3 Participants
Standard smoking cessation counseling plus HW, a didactic health education counseling on ways women can physically care for themselves during pregnancy and postpartum.
|
Aim 3: Assigned Behavioral Activation
n=3 Participants
Standard smoking cessation counseling plus BA, which focuses on increasing rewarding and adaptive behaviors and decreasing avoidance and withdrawal
|
|---|---|---|
|
Abstinence
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 4 1/2 months postpartumPopulation: Analysis was not a part of AIM 1 \& AIM 3 for this outcome measure.
Depression as assessed using the Patient Health Questionnaire (PHQ-9) measure. The PHQ 9 is the major depressive episode scale from the Patient Health Questionnaire (PHQ). There are nine items on the Patient Health Questionnaire (PHQ-9). The PHQ-9 Depression Severity score is calculated by assigning score of 0, 1, 2, 3 to the response category of "not at all", "several days", "more than half, the days", and "nearly every day", respectively. The PHQ-9 total score for the nine items ranges from 0 to 27. The higher the value indicates a more severe score. The total score is a combination of the number of total symptoms experienced and the frequency of those symptoms over a two week period. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. There are no subscales on the PHQ-9
Outcome measures
| Measure |
AIM 3: Assigned Health & Wellness (HW)
n=3 Participants
Standard smoking cessation counseling plus HW, a didactic health education counseling on ways women can physically care for themselves during pregnancy and postpartum.
|
Aim 3: Assigned Behavioral Activation
n=3 Participants
Standard smoking cessation counseling plus BA, which focuses on increasing rewarding and adaptive behaviors and decreasing avoidance and withdrawal
|
|---|---|---|
|
Depression
|
0.67 scores on a scale
Standard Deviation 1.15
|
7.34 scores on a scale
Standard Deviation 10.21
|
Adverse Events
AIM 3: Women Assigned to Health & Wellness (HW)
AIM 3: Women Assigned to Behavioral Activation (BA)
AIM 4: Health & Wellness (HW)
AIM 4: Behavioral Activation (BA)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place