Mommy-Baby Treatment for Perinatal Depression

NCT ID: NCT01744041

Last Updated: 2022-01-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder, Major Postpartum Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dyadic Interpersonal Psychotherapy

Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum

Group Type EXPERIMENTAL

Dyadic Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

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.

Enhanced Treatment as Usual

Personalized referral to community resources for depression treatment

Group Type ACTIVE_COMPARATOR

Enhanced Treatment as Usual

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dyadic Interpersonal Psychotherapy

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 BEHAVIORAL

Enhanced Treatment as Usual

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shannon Lenze, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington Univeristy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25604869 (View on PubMed)

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.

Reference Type RESULT
PMID: 28038377 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32479328 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23MH090245

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201203136

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Art Therapy in Obstetric Patients
NCT05503056 COMPLETED NA
Antimanic Drug Use in Pregnancy
NCT00585702 COMPLETED