NCT00251043

Brief Summary

This study will evaluate the effectiveness of interpersonal psychotherapy in treating pregnant women with depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for phase_4 depression

Timeline
Completed

Started Sep 2005

Typical duration for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

4.6 years

First QC Date

November 7, 2005

Last Update Submit

March 23, 2012

Conditions

Depression

Keywords

PregnancyAntepartum DepressionMajor Depression

Outcome Measures

Primary Outcomes (1)

  • Depression

    Measured weekly for 12 weeks antepartum and Weeks 4, 8, 12, 16, and 24 postpartum

Secondary Outcomes (1)

  • Mother-infant bonding

    Measured at Weeks 4, 8, 12, 16, and 24 postpartum

Study Arms (2)

1

EXPERIMENTAL

Participants will Psychotherapy weekly for 12 weeks

Behavioral: Interpersonal psychotherapy for depression in pregnancy

2

ACTIVE COMPARATOR

Parenting Education will include 45-minute weekly sessions for 12 week

Behavioral: Parenting education program (PEP)

Interventions

Interpersonal psychotherapy for depression in pregnancyBEHAVIORAL

IPT-P will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn ways to address emotional stressors associated with childbirth.

Also known as: psychotherapy
1
Parenting education program (PEP)BEHAVIORAL

PEP will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn about the stages of pregnancy, childbirth, and early infant development.

Also known as: PEP
2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Depressed Pregnant women between 18-45 years
  • Meets diagnostic criteria for a major depressive disorder
  • Reads and understands English or Spanish
  • Physically healthy without serious medical illness
  • Between 12 and 33 weeks gestation
  • Meets diagnostic criteria of DSM-V for a major depressive disorder
  • HAM-D score \> 12
  • EPDS\>10

You may not qualify if:

  • Drug or alcohol abuse in the 6 months prior to study entry
  • Acute risk for suicide
  • Clinically significant co-morbid Axis1 disorders
  • High risk pregnancy or medical conditions that affect pregnancy when participation in the study will add to risk or compromise the medical condition
  • History of or present non-drug induced psychosis
  • Currently taking antidepressant medication
  • Exclude severe (HAM-D (17 items) score \>24) depression prominent vegetative symptoms and or loss of appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (5)

  • Spinelli MG, Endicott J. Controlled clinical trial of interpersonal psychotherapy versus parenting education program for depressed pregnant women. Am J Psychiatry. 2003 Mar;160(3):555-62. doi: 10.1176/appi.ajp.160.3.555.

    PMID: 12611838BACKGROUND

  • Spinelli MG, Endicott J, Goetz RR, Segre LS. Reanalysis of efficacy of interpersonal psychotherapy for antepartum depression versus parenting education program: initial severity of depression as a predictor of treatment outcome. J Clin Psychiatry. 2016 Apr;77(4):535-40. doi: 10.4088/JCP.15m09787.

    PMID: 27137422DERIVED

  • Spinelli MG, Endicott J, Goetz RR. Disagreement between therapist raters and independent evaluators in a controlled clinical trial of interpersonal psychotherapy for depressed pregnant women. J Psychiatr Pract. 2015 Mar;21(2):114-23. doi: 10.1097/01.pra.0000462604.79606.4e.

    PMID: 25782762DERIVED

  • Spinelli MG, Endicott J, Goetz RR. Increased breastfeeding rates in black women after a treatment intervention. Breastfeed Med. 2013 Dec;8(6):479-84. doi: 10.1089/bfm.2013.0051. Epub 2013 Aug 24.

    PMID: 23971683DERIVED

  • Spinelli MG, Endicott J, Leon AC, Goetz RR, Kalish RB, Brustman LE, Carmona YR, Meyreles Q, Vega M, Schulick JL. A controlled clinical treatment trial of interpersonal psychotherapy for depressed pregnant women at 3 New York City sites. J Clin Psychiatry. 2013 Apr;74(4):393-9. doi: 10.4088/JCP.12m07909.

    PMID: 23656847DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Interpersonal PsychotherapyPregnancyPsychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and ActivitiesReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Margaret G. Spinelli, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

  • Jean Endicott, PhD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 9, 2005

Study Start

September 1, 2005

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

US(1)