NCT00292903

Brief Summary

This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2004

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

3.8 years

First QC Date

February 15, 2006

Last Update Submit

September 6, 2012

Conditions

Keywords

Perinatal DepressionInterpersonal Psychotherapy

Outcome Measures

Primary Outcomes (2)

  • Depressive symptoms

    Measured throughout treatment and at Months 2 and 6 postpartum

  • Treatment attendance

    Measured at Week 12

Study Arms (2)

A

EXPERIMENTAL
Behavioral: Brief interpersonal psychotherapy

B

ACTIVE COMPARATOR
Behavioral: Facilitated referral for treatment as usual

Interventions

IPT-B sessions include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment.

A

F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.

B

Eligibility Criteria

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

You may qualify if:

  • Between 8 and 32 weeks of gestation at time of study entry
  • A score above 12 on the Edinburgh Postnatal Depression Scale
  • Speaks English
  • Resides in the Pittsburgh, PA, area
  • Access to a household telephone

You may not qualify if:

  • Currently receiving treatment for depression (i.e., medication or psychotherapy)
  • History of a prior manic episode
  • Alcohol or drug abuse or dependence within 6 months of study entry
  • Psychotic disorder or organic mental disorder
  • Suicidal, homicidal, or requires hospitalization
  • Severe sexual and/or physical aggression in relationship with partner or husband
  • Significant medical illness such as epilepsy, autoimmune disorder, liver dysfunction, or unstable endocrine disease
  • Severe cognitive deficits that would prevent treatment with psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Nancy K. Grote, PhD

    University of Pittsburgh, School of Social Work

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 16, 2006

Study Start

March 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations