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Group Therapy for Postpartum Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00051246
First received: January 7, 2003
Last updated: December 20, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention
Depression, Postpartum
 Behavioral: Mother-Infant Group Psychotherapy
Behavioral: Interpersonal Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Relational Group Intervention for Postpartum Depression

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD) [ Time Frame: Measured at post-treatment and Month 12 follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: January 2002
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Individual interpersonal psychotherapy
 Behavioral: Interpersonal Psychotherapy
Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051246

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

No publications provided

Responsible Party: Dr. Roseanne Clark, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00051246     History of Changes
Other Study ID Numbers: R01 MH62054, DSIR CT-P
Study First Received: January 7, 2003
Last Updated: December 20, 2007
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 16, 2013