Clinician Managed Interpersonal Psychotherapy

September 25, 2013 updated by: University of Iowa
This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CM-IPT is delivered in 12 sessions over the course of a year. Standard IPT is delivered in 12 sessions in the first 12 weeks after treatment assignment.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Women between 8 and 24 weeks postpartum
  • Meet DSM-IV criteria for Major Depression
  • Hamilton Rating Scale for Depression score of 12 or more

Exclusion criteria:

  • Active substance abuse
  • Psychotic disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive clinician-managed interpersonal psychotherapy
Behavioral: Clinician managed interpersonal psychotherapy (CM-IPT)
Participants will receive 12 sessions of CM-IPT over 1 year.
Active Comparator: 2
Participants will receive standard interpersonal psychotherapy
Behavioral: Standard interpersonal psychotherapy (IPT)
Participants will receive 12 sessions of IPT over 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Rating Scale for Depression
Time Frame: Measured at Week 12
Measured at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Scott P. Stuart, MD, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 9, 2002

First Submitted That Met QC Criteria

August 12, 2002

First Posted (Estimate)

August 13, 2002

Study Record Updates

Last Update Posted (Estimate)

September 26, 2013

Last Update Submitted That Met QC Criteria

September 25, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH059668 (U.S. NIH Grant/Contract)
  • DSIR 83-ATAS (NIMH Program Class Code)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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