Clinician Managed Interpersonal Psychotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00043602
First received: August 9, 2002
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Depression
Depression, Postpartum
Behavioral: Standard interpersonal psychotherapy (IPT)
Behavioral: Clinician managed interpersonal psychotherapy (CM-IPT)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinician Managed Interpersonal Psychotherapy

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: September 2001
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043602

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Scott P. Stuart, MD University of Iowa
  More Information

No publications provided

Responsible Party: Scott Stuart, University of Iowa
ClinicalTrials.gov Identifier: NCT00043602     History of Changes
Other Study ID Numbers: R01 MH59668, R01MH059668, DSIR 83-ATAS
Study First Received: August 9, 2002
Last Updated: September 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on August 28, 2014