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PREPP: Preventing Postpartum Depression (PREPP)

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ClinicalTrials.gov Identifier: NCT03283254
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Catherine Monk, New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE August 14, 2017
First Posted Date  ICMJE September 14, 2017
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE October 17, 2017
Estimated Primary Completion Date July 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
Postpartum Depression Symptoms [ Time Frame: 6-16 weeks postpartum ]
Postpartum Depression Symptoms measured by Edinburgh Postnatal Depression Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03283254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • Improved Sleep [ Time Frame: 3rd trimester of pregnancy - 16 weeks postpartum ]
    Improved self-report of sleep quality on Pittsburgh Sleep Quality Index and improved sleep shown on actigraphy monitor
  • Infant Behavior [ Time Frame: 6 & 16 weeks postpartum ]
    Cry behavior and sleep behavior measured by The Baby Day Diary
  • Greater infant left frontal EEG power reflecting sleep spindle activity [ Time Frame: Newborn-6 weeks postpartum ]
    More positive perceptions and objective assessments of maternal postpartum sleep efficiency will be mediated by greater infant left frontal EEG power reflecting sleep spindle activity and associated longer average durations of infant nocturnal sleep per maternal report and actigraphy.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
Infant Behavior [ Time Frame: 6 & 16 weeks postpartum ]
Cry behavior and sleep behavior measured by The Baby Day Diary
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PREPP: Preventing Postpartum Depression
Official Title  ICMJE Preventing Postpartum Depression: A Dyadic Approach Adjunctive to Obstetric Care
Brief Summary The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the mother-infant interaction and subsequent child development. Specifically, the study team will investigate: (1) the effectiveness of the intervention compared to usual care; (2) if the effects of the intervention can be detected in the assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or postnatal biomarkers that can help identify infants whose behavior is more likely to play a role in their mothers' depression; (4) if these markers differentiate which infants will be most responsive to the intervention(s); and (5), if assessments of brain function at birth and at 4-6 weeks of age provide biological nodal points for identifying the effects of the intervention on infant brain development. Participants will be recruited during their 2nd trimester, and will be randomly separated into one of two groups: a group that receives coaching in parenting techniques (4 in-person coaching sessions and 1 phone session) or one that receives treatment as usual.
Detailed Description

Of the nearly 4 million mothers delivering live births each year in the United States, approximately 560,000 — or 14% — will develop major or minor depression within the first four months postpartum, when the rate peaks. This number dwarfs prevalence rates for gestational diabetes (2-5%) and is comparable to preterm birth (11.4%). Postpartum depression (PPD) has substantial consequences: poorer maternal quality of life, significant emotional suffering, and suicide risk. PPD predicts diminished mother-infant bonding, and poor outcomes in social-emotional and, in some groups, cognitive development. PPD is undertreated in part because women are reluctant to seek treatment due to the stigma associated with mental health care, logistical barriers to at-tending added health care appointments, and disinclination to take medications while breastfeeding. Of preventive interventions, few embed services in obstetrical care or leverage the unique mother-infant dyadic orientation of the childbearing period. The investigators developed a novel intervention based on the conceptualization of maternal depression as a potential disorder of the mother-infant dyad, and one that can be approached through psychological and behavioral changes in the mother — commencing before birth — that affect her and the child. PREPP (Practical Resources for Effective Postpartum Parenting) enrolls distressed pregnant women at risk for PPD, spans late pregnancy to the 6 week postpartum check up, comprises four in-person 'coaching' sessions adjunctive to obstetrical (OB) prenatal and postnatal appointments, one phone session, and imparts (a) mindfulness and self-reflection skills, (b) parenting skills, and (c) psycho-education.

The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the mother-infant interaction and subsequent child development.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two groups: One receives PREPP prevention intervention and the other group receives Enhanced Treatment as Usual (psychoeducation about Postpartum Depression, referral and monitoring)
Masking: Single (Outcomes Assessor)
Masking Description:
The person administering the outcome measures is blind to participant group.
Primary Purpose: Prevention
Condition  ICMJE Postpartum Depression
Intervention  ICMJE
  • Behavioral: Practical Resources for Effective Postpartum Parenting
    A preventive psychotherapy intervention for Postpartum Depression
    Other Name: PREPP
  • Behavioral: Enhanced Treatment As Usual
    Psychoeducation about Postpartum Depression, referral to treatment in the community, clinical monitoring
    Other Name: ETAU
Study Arms  ICMJE
  • Experimental: Practical Resources for Effective Postpartum (PREPP)
    A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.
    Intervention: Behavioral: Practical Resources for Effective Postpartum Parenting
  • Active Comparator: Enhanced Treatment as Usual
    Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring
    Intervention: Behavioral: Enhanced Treatment As Usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 10, 2022
Estimated Primary Completion Date July 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy pregnant women between 18-45 years old (based on self report)
  2. A score of ≥21 on the Predictive Index of Postnatal Depression (PIPD), indicating risk for developing postpartum depression
  3. A healthy, singleton pregnancy (based on self report)
  4. English speaking (based on self report)
  5. Receiving standard prenatal care (based on self report)

Exclusion Criteria:

  1. Multi-fetal pregnancy (based on self-report)
  2. Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
  3. Acute medical illness or significant pregnancy complication (based on self-report)
  4. Currently in weekly, individual psychotherapy, including psychopharmacology (based on self report)
  5. Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elizabeth Werner, Ph.D. 6463191008 ew150@cumc.columbia.edu
Contact: Catherine Monk, Ph.D. 917-543-6031 cem31@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03283254
Other Study ID Numbers  ICMJE 7428
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data may be made available to other researchers.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: After the completion of the study
Access Criteria: Permission of the PI
Responsible Party Catherine Monk, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine Monk, Ph.D. Columbia University
Study Director: Elizabeth Werner, Ph.D. Columbia University
PRS Account New York State Psychiatric Institute
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP