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Clinician Managed Interpersonal Psychotherapy

Primary Purpose

Depression, Depression, Postpartum

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Standard interpersonal psychotherapy (IPT)

Clinician managed interpersonal psychotherapy (CM-IPT)

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Participants will receive clinician-managed interpersonal psychotherapy

Participants will receive standard interpersonal psychotherapy

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression

Secondary Outcome Measures

Full Information

NCT ID

NCT00043602

First Posted

August 9, 2002

Last Updated

September 25, 2013

Sponsor

University of Iowa

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00043602

Brief Title

Clinician Managed Interpersonal Psychotherapy

Official Title

Clinician Managed Interpersonal Psychotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

September 2001 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Iowa

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Depression, Postpartum

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Participants will receive clinician-managed interpersonal psychotherapy

Arm Title

Arm Type

Active Comparator

Arm Description

Participants will receive standard interpersonal psychotherapy

Intervention Type

Behavioral

Intervention Name(s)

Standard interpersonal psychotherapy (IPT)

Intervention Description

Participants will receive 12 sessions of IPT over 12 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Clinician managed interpersonal psychotherapy (CM-IPT)

Intervention Description

Participants will receive 12 sessions of CM-IPT over 1 year.

Primary Outcome Measure Information:

Title

Hamilton Rating Scale for Depression

Time Frame

Measured at Week 12

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott P. Stuart, MD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

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Clinician Managed Interpersonal Psychotherapy

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