NCT00051246

Brief Summary

This study will compare standard individual treatment to group therapy for the treatment of postpartum depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

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

January 1, 2002

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2003

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

6.5 years

First QC Date

January 7, 2003

Last Update Submit

January 23, 2014

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (1)

  • Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)

    Measured at post-treatment and Month 12 follow-up

Secondary Outcomes (1)

  • Improvement in parent-infant interactions as measured by the Early Relational Assessment (ERA)

    Measured at post-treatment, Month 12 follow-up, and 12 and 24 months of age

Study Arms (2)

1 M-ITG

ACTIVE COMPARATOR

Mother-infant group psychotherapy

Behavioral: Mother-Infant Group Psychotherapy

2 - IPT

ACTIVE COMPARATOR

Individual interpersonal psychotherapy

Behavioral: Interpersonal Psychotherapy

Interventions

Mother-Infant Group PsychotherapyBEHAVIORAL

Mother-infant group psychotherapy consists of weekly 2.5-hour psychotherapy sessions comprised of mother's group therapy, infant developmental therapy, and mother-infant dyadic psychotherapy. Group treatment will last 15 weeks.

1 M-ITG
Interpersonal PsychotherapyBEHAVIORAL

Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks.

2 - IPT

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depression with an infant under 7 months of age

You may not qualify if:

  • Bipolar disorder
  • Schizophrenia
  • Organic brain syndrome
  • Antisocial personality disorder
  • Current psychosis or mania
  • Lifetime history of mental retardation
  • Current alcohol or substance abuse
  • Cognitive disability
  • Infants born more than 6 weeks premature or with major medical conditions or developmental disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Dept. of Psychiatry

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Roseanne Clark, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2003

First Posted

January 8, 2003

Study Start

January 1, 2002

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

US(1)