NCT00380419

Brief Summary

This study will evaluate the impact of interpersonal psychotherapy on the course of depression during and after pregnancy, as well as its effect on infant birth outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

2.8 years

First QC Date

September 22, 2006

Last Update Submit

May 29, 2013

Conditions

Keywords

PregnancyPostpartum Depression

Outcome Measures

Primary Outcomes (2)

  • Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17)

    Measured during pregnancy and the first 7 months after delivery

  • Infant birth outcomes

    Measured during the first 7 months after delivery

Secondary Outcomes (1)

  • Biologic measures related to depression in both mothers and infants

    Measured through 14 months fter delivery

Study Arms (1)

1

EXPERIMENTAL

Participants will receive 16 sessions of interpersonal psychotherapy

Behavioral: Interpersonal Psychotherapy (IPT)

Interventions

IPT sessions will address adjustment to pregnancy, concerns about interpersonal relationships, and parenting concerns. Sessions will be weekly, but may be determined by clinical desires of patient and therapist.

1

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • No more than 28 weeks pregnant at the time of study entry
  • History of depression or anxiety
  • Current symptoms of distress
  • Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS)
  • English-speaking

You may not qualify if:

  • Plans to move away from the area prior to giving birth
  • Current use of steroids for medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersDepression, Postpartum

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sheila M. Marcus, MD

    Universitiy of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Director Child & Adolescent Psychiatry

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 26, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations