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Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression

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ClinicalTrials.gov Identifier: NCT01379781
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Postpartum Depression
Intervention Behavioral: Behavioral Intervention for PPD
Enrollment 54

Recruitment Details Recruitment took place between July 2011 and November 2013 at Columbia University Medical Center.
Pre-assignment Details All enrolled participants were randomized.
Arm/Group Title Behavioral Intervention for Postpartum Depression Treatment As Usual
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 27 27
Completed 16 19
Not Completed 11 8
Reason Not Completed
Lost to Follow-up             11             8
Arm/Group Title Behavioral Intervention for PPD Treatment As Usual Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
27
 100.0%
54
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
30.87  (6.51) 29.60  (5.67) 30.24  (6.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
27
 100.0%
27
 100.0%
54
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Hispanic or Latino
15
  55.6%
16
  59.3%
31
  57.4%
Not Hispanic or Latino
10
  37.0%
10
  37.0%
20
  37.0%
Unknown or Not Reported
2
   7.4%
1
   3.7%
3
   5.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   7.4%
2
   7.4%
4
   7.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  14.8%
6
  22.2%
10
  18.5%
White
4
  14.8%
2
   7.4%
6
  11.1%
More than one race
1
   3.7%
0
   0.0%
1
   1.9%
Unknown or Not Reported
16
  59.3%
17
  63.0%
33
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 54 participants
27 27 54
Hamilton Rating Scales of Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 27 participants 54 participants
18.48  (12.82) 13.83  (17.17) 16.16  (15.00)
[1]
Measure Description:
  • 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
1.Primary Outcome
Title Hamilton Rating Scales of Depression
Hide Description
  • 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
Time Frame 6 weeks postpartum
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Those in the analysis received both baseline and 6-week assessment sessions.
Arm/Group Title Behavioral Intervention for PPD Treatment As Usual
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 22 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.09  (7.31) 17.17  (9.81)
Time Frame Adverse event data was collected up until 4 months postpartum.
Adverse Event Reporting Description Participants were screened with the Hamilton Rating Scales for Depression and the Hamilton Anxiety Scales by a trained rater.
 
Arm/Group Title Behavioral Intervention for PPD Treatment As Usual
Hide Arm/Group Description

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.

Referred to Treatment in the Community.
All-Cause Mortality
Behavioral Intervention for PPD Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Behavioral Intervention for PPD Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavioral Intervention for PPD Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Catherine Monk, Ph.D., Assoc Professor
Organization: Columbia University Medical Center
Phone: (646) 774-8941
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01379781     History of Changes
Other Study ID Numbers: #6285
First Submitted: June 22, 2011
First Posted: June 23, 2011
Results First Submitted: May 12, 2015
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015