Group Therapy for Postpartum Depression - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00051246

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:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Relational Group Intervention for Postpartum Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression Postpartum Care Postpartum Depression

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
1: Active Comparator 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.
2: Active Comparator 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:	University of Wisconsin ( Dr. Roseanne Clark )
Study ID Numbers:	R01 MH62054, DSIR CT-P
Study First Received:	January 7, 2003
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00051246 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum

Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 27, 2009