Mommy-Baby Treatment for Perinatal Depression
Primary Purpose
Depressive Disorder, Major, Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dyadic Interpersonal Psychotherapy
Enhanced Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring depression, pregnancy, postpartum, psychotherapy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women
- 18 years and older
- between 12 and 30 weeks gestation
- Score greater than or equal to 13 on Edinburgh Depression Scale
- Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified
- English Speaking
Exclusion Criteria:
- Substance abuse or dependence in past 3 months
- Active suicidal or homicidal ideation
- Bipolar disorder, psychotic disorder
- unstable medical condition or other medical/obstetrical complication
- Evidence of severe intimate partner violence
- Ongoing psychosocial or pharmacotherapy for depression
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dyadic Interpersonal Psychotherapy
Enhanced Treatment as Usual
Arm Description
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
Personalized referral to community resources for depression treatment
Outcomes
Primary Outcome Measures
Change in Edinburgh Depression Scale From Baseline
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT01744041
First Posted
November 27, 2012
Last Updated
December 16, 2021
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01744041
Brief Title
Mommy-Baby Treatment for Perinatal Depression
Official Title
Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad will be better than treatment as usual in reducing depressive symptoms, improving psychosocial functioning,increasing parenting self-efficacy, improving infant emotional development, and enhancing mother-infant relationship quality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Postpartum Depression
Keywords
depression, pregnancy, postpartum, psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dyadic Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
Arm Title
Enhanced Treatment as Usual
Arm Type
Active Comparator
Arm Description
Personalized referral to community resources for depression treatment
Intervention Type
Behavioral
Intervention Name(s)
Dyadic Interpersonal Psychotherapy
Intervention Description
This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship.
Intervention Type
Other
Intervention Name(s)
Enhanced Treatment as Usual
Intervention Description
This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone.
Primary Outcome Measure Information:
Title
Change in Edinburgh Depression Scale From Baseline
Description
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.
Time Frame
Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women
18 years and older
between 12 and 30 weeks gestation
Score greater than or equal to 13 on Edinburgh Depression Scale
Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified
English Speaking
Exclusion Criteria:
Substance abuse or dependence in past 3 months
Active suicidal or homicidal ideation
Bipolar disorder, psychotic disorder
unstable medical condition or other medical/obstetrical complication
Evidence of severe intimate partner violence
Ongoing psychosocial or pharmacotherapy for depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Lenze, Ph.D.
Organizational Affiliation
Washington Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25604869
Citation
Lenze SN, Rodgers J, Luby J. A pilot, exploratory report on dyadic interpersonal psychotherapy for perinatal depression. Arch Womens Ment Health. 2015 Jun;18(3):485-91. doi: 10.1007/s00737-015-0503-6. Epub 2015 Jan 22.
Results Reference
result
PubMed Identifier
28038377
Citation
Lenze SN, Potts MA. Brief Interpersonal Psychotherapy for depression during pregnancy in a low-income population: A randomized controlled trial. J Affect Disord. 2017 Mar 1;210:151-157. doi: 10.1016/j.jad.2016.12.029. Epub 2016 Dec 20.
Results Reference
result
PubMed Identifier
32479328
Citation
Lenze SN, Potts MA, Rodgers J, Luby J. Lessons learned from a pilot randomized controlled trial of dyadic interpersonal psychotherapy for perinatal depression in a low-income population. J Affect Disord. 2020 Jun 15;271:286-292. doi: 10.1016/j.jad.2020.03.084. Epub 2020 Apr 15.
Results Reference
derived
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Mommy-Baby Treatment for Perinatal Depression
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