Expired Study
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Madison, Wisconsin 53719


Purpose:

This study will compare standard individual treatment to group therapy for the treatment of postpartum depression.


Study summary:

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.


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


Study is Available At:


Original ID:

R01 MH62054


NCT ID:

NCT00051246


Secondary ID:

R01MH062054


Study Acronym:


Brief Title:

Group Therapy for Postpartum Depression


Official Title:

Relational Group Intervention for Postpartum Depression


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

147


Enrollment Type:

Actual


Overall Contact Information

Official Name:Roseanne Clark, PhD
Principal Investigator
University of Wisconsin, Madison

Study Dates

Start Date:January 2002
Completion Date:July 2008
Completion Type:Actual
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:January 2014
Last Changed Date:January 23, 2014
First Received Date:January 7, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure:Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)
Time Frame:Measured at post-treatment and Month 12 follow-up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Mother-Infant Group Psychotherapy
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.
Arm Name:1 M-ITG
Intervention Type:Behavioral
Name:Interpersonal Psychotherapy
Description:Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks.
Arm Name:2 - IPT

Study Arms

Study Arm Type:Active Comparator
Arm Name:1 M-ITG
Description:Mother-infant group psychotherapy
Study Arm Type:Active Comparator
Arm Name:2 - IPT
Description:Individual interpersonal psychotherapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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