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Clinician Managed Interpersonal Psychotherapy

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00043602
First received: August 9, 2002
Last updated: March 4, 2008
Last verified: March 2008
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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
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
National Institute of Mental Health (NIMH)
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, DSIR 83-ATAS
Study First Received: August 9, 2002
Last Updated: March 4, 2008
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 May 23, 2013