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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place between July 2011 and November 2013 at Columbia University Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants were randomized.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Behavioral Intervention for Postpartum Depression   Treatment As Usual
STARTED   27   27 
COMPLETED   16   19 
NOT COMPLETED   11   8 
Lost to Follow-up                11                8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Behavioral Intervention for PPD

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

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 Total of all reporting groups

Baseline Measures
   Behavioral Intervention for PPD   Treatment As Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   27   54 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   27   27   54 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.87  (6.51)   29.60  (5.67)   30.24  (6.09) 
Gender 
[Units: Participants]
     
Female   27   27   54 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   15   16   31 
Not Hispanic or Latino   10   10   20 
Unknown or Not Reported   2   1   3 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   2   4 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   4   6   10 
White   4   2   6 
More than one race   1   0   1 
Unknown or Not Reported   16   17   33 
Region of Enrollment 
[Units: Participants]
     
United States   27   27   54 
Hamilton Rating Scales of Depression [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.48  (12.82)   13.83  (17.17)   16.16  (15.00) 
[1]
  • 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

1.  Primary:   Hamilton Rating Scales of Depression   [ Time Frame: 6 weeks postpartum ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: cem31@columbia.edu



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