Trial Outcomes & Findings for Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression (NCT NCT01379781)
NCT ID: NCT01379781
Last Updated: 2024-07-03
Results Overview
* Assessing severity of depression; clinician rated * 24 questions * 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe * 11 items are scored from 0-2 * A composite score is created by the sum of the scores from all items. Scores can range from 0-74 * 0-7: normal * 8-13: mild depression * 14-18: moderate depression * 19-23: severe depression * 24: very severe depression * Higher summed values indicate a greater severity of depression
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
6 weeks postpartum
Results posted on
2024-07-03
Participant Flow
Recruitment took place between July 2011 and November 2013 at Columbia University Medical Center.
All enrolled participants were randomized.
Participant milestones
| Measure |
Behavioral Intervention for Postpartum Depression
Behavioral Intervention for Postpartum Depression delivered over 3 in-person sessions.
Behavioral Intervention for Postpartum Depression: We will select a sample of pregnant women at risk for Postpartum Depression, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
|
Treatment As Usual
Referred to Treatment in the Community.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Behavioral Intervention for Postpartum Depression
Behavioral Intervention for Postpartum Depression delivered over 3 in-person sessions.
Behavioral Intervention for Postpartum Depression: We will select a sample of pregnant women at risk for Postpartum Depression, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
|
Treatment As Usual
Referred to Treatment in the Community.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
8
|
Baseline Characteristics
Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression
Baseline characteristics by cohort
| Measure |
Behavioral Intervention for PPD
n=27 Participants
Behavioral Intervention for PPD delivered over 3 in-person sessions.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
|
Treatment As Usual
n=27 Participants
Referred to Treatment in the Community.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.87 years
STANDARD_DEVIATION 6.51 • n=5 Participants
|
29.60 years
STANDARD_DEVIATION 5.67 • n=7 Participants
|
30.24 years
STANDARD_DEVIATION 6.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Hamilton Rating Scales of Depression
|
18.48 units on a scale
STANDARD_DEVIATION 12.82 • n=5 Participants
|
13.83 units on a scale
STANDARD_DEVIATION 17.17 • n=7 Participants
|
16.16 units on a scale
STANDARD_DEVIATION 15.00 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postpartumPopulation: Those in the analysis received both baseline and 6-week assessment sessions.
* Assessing severity of depression; clinician rated * 24 questions * 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe * 11 items are scored from 0-2 * A composite score is created by the sum of the scores from all items. Scores can range from 0-74 * 0-7: normal * 8-13: mild depression * 14-18: moderate depression * 19-23: severe depression * 24: very severe depression * Higher summed values indicate a greater severity of depression
Outcome measures
| Measure |
Behavioral Intervention for PPD
n=22 Participants
Behavioral Intervention for PPD delivered over 3 in-person sessions.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
|
Treatment As Usual
n=23 Participants
Referred to Treatment in the Community.
Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
|
|---|---|---|
|
Hamilton Rating Scales of Depression
|
12.09 units on a scale
Standard Deviation 7.31
|
17.17 units on a scale
Standard Deviation 9.81
|
Adverse Events
Behavioral Intervention for PPD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment As Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Catherine Monk, Ph.D., Assoc Professor
Columbia University Medical Center
Phone: (646) 774-8941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place