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Group Therapy for Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00051246
Recruitment Status : Completed
First Posted : January 8, 2003
Last Update Posted : January 24, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment
Depression, Postpartum Behavioral: Mother-Infant Group Psychotherapy Behavioral: Interpersonal Psychotherapy

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Relational Group Intervention for Postpartum Depression
Study Start Date : January 2002
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051246

United States, Wisconsin
University of Wisconsin Dept. of Psychiatry
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute of Mental Health (NIMH)
Principal Investigator: Roseanne Clark, PhD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00051246     History of Changes
Other Study ID Numbers: R01MH062054 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2003    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

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