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Group Therapy for Postpartum Depression

Primary Purpose

Depression, Postpartum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mother-Infant Group Psychotherapy
Interpersonal Psychotherapy
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Postpartum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Major depression with an infant under 7 months of age Exclusion Criteria: Bipolar disorder Schizophrenia Organic brain syndrome Antisocial personality disorder Current psychosis or mania Lifetime history of mental retardation Current alcohol or substance abuse Cognitive disability Infants born more than 6 weeks premature or with major medical conditions or developmental disabilities

Sites / Locations

  • University of Wisconsin Dept. of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 M-ITG

2 - IPT

Arm Description

Mother-infant group psychotherapy

Individual interpersonal psychotherapy

Outcomes

Primary Outcome Measures

Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)

Secondary Outcome Measures

Improvement in parent-infant interactions as measured by the Early Relational Assessment (ERA)

Full Information

First Posted
January 7, 2003
Last Updated
January 23, 2014
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00051246
Brief Title
Group Therapy for Postpartum Depression
Official Title
Relational Group Intervention for Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare standard individual treatment to group therapy for the treatment of postpartum depression.
Detailed Description
Ten to twenty percent of new mothers experience major depression in the postpartum period or postpartum depression (PPD). This condition poses a risk for disturbances in the mother-infant relationship as well as for developmental delays and subsequent psychopathology in their children. Thus, and investigation of the efficacy of a relational approach that focuses on improving the mother's sense of competence in the parenting role, and reducing depressive symptoms and social isolation through group therapy is warranted. Patients are randomly assigned to either relational group treatment or to standard individual treatment. Assessments of maternal and infant functioning, mother-infant and father-infant relations, parenting stress, and marital conflict and conducted pre- and post-treatment, at 12 months post-treatment, and when infants are 12 and 24 months of age.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 M-ITG
Arm Type
Active Comparator
Arm Description
Mother-infant group psychotherapy
Arm Title
2 - IPT
Arm Type
Active Comparator
Arm Description
Individual interpersonal psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Mother-Infant Group Psychotherapy
Intervention Description
Mother-infant group psychotherapy consists of weekly 2.5-hour psychotherapy sessions comprised of mother's group therapy, infant developmental therapy, and mother-infant dyadic psychotherapy. Group treatment will last 15 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks.
Primary Outcome Measure Information:
Title
Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)
Time Frame
Measured at post-treatment and Month 12 follow-up
Secondary Outcome Measure Information:
Title
Improvement in parent-infant interactions as measured by the Early Relational Assessment (ERA)
Time Frame
Measured at post-treatment, Month 12 follow-up, and 12 and 24 months of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major depression with an infant under 7 months of age Exclusion Criteria: Bipolar disorder Schizophrenia Organic brain syndrome Antisocial personality disorder Current psychosis or mania Lifetime history of mental retardation Current alcohol or substance abuse Cognitive disability Infants born more than 6 weeks premature or with major medical conditions or developmental disabilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roseanne Clark, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Dept. of Psychiatry
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

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Group Therapy for Postpartum Depression

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