Group Therapy for Postpartum Depression

Depression, Postpartum Clinical Trial

Official title:

Relational Group Intervention for Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051246
• Other study ID #: R01MH062054
• Secondary ID: R01MH062054
• Status: Completed
• Phase: N/A
• First received: January 7, 2003
• Last updated: January 23, 2014
• Start date: January 2002
• Est. completion date: July 2008

Study information

• Verified date: January 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

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.
• Interpersonal Psychotherapy
Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss. Individual treatment period will last 15 weeks.

Locations

Country	Name	City	State
United States	University of Wisconsin Dept. of Psychiatry	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)		Measured at post-treatment and Month 12 follow-up	No
Secondary	Improvement in parent-infant interactions as measured by the Early Relational Assessment (ERA)		Measured at post-treatment, Month 12 follow-up, and 12 and 24 months of age	No