- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00051246
Group Therapy for Postpartum Depression
Relational Group Intervention for Postpartum Depression
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53719
- University of Wisconsin Dept. of Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1 M-ITG
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
|
Individual psychotherapy treatment focuses on role transition, interpersonal relationships, and loss.
Individual treatment period will last 15 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction of depression as measured by the Hamilton Rating Scale for Depression (HRSD)
Time Frame: Measured at post-treatment and Month 12 follow-up
|
Measured at post-treatment and Month 12 follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Measured at post-treatment, Month 12 follow-up, and 12 and 24 months of age
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Roseanne Clark, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH062054 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression, Postpartum
-
Women and Infants Hospital of Rhode IslandNot yet recruitingPostpartum Anxiety | Paternal Postpartum Depression
-
Bekelu Teka WorkuJimma UniversityNot yet recruitingPrenatal Depression | Mental Health Related Quality of Life | Maternal Postpartum Depression | Paternal Postpartum DepressionEthiopia
-
Jordan University of Science and TechnologyActive, not recruitingPostpartum Depression | Postpartum Depression (PPD)Jordan
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Afyonkarahisar Health Sciences UniversityNot yet recruitingPostpartum Depression | Postpartum Anxiety
-
University Hospital, ToulouseCompletedPostnatal Depression | Postpartum Depression (PPD)France
Clinical Trials on Mother-Infant Group Psychotherapy
-
Sakarya UniversityNot yet recruitingEarly Mother-Baby Attachment
-
Ullevaal University HospitalUniversity of Oslo; The Royal Norwegian Ministry of Health; Regionsenter for... and other collaboratorsUnknown
-
Icahn School of Medicine at Mount SinaiCompletedOther Preterm InfantsUnited States
-
Universiti Putra MalaysiaGuilin University of Technology, China; National Engineering Center of Dairy...RecruitingAsthma | Eczema | Gut Microbiota | Breast Milk Collection | Gastrointestinal Symptoms | TemperamentMalaysia
-
Sabanci UniversityNot yet recruitingNurse's Role | Maternal Behavior | Infant DevelopmentTurkey
-
Rambam Health Care CampusCompletedPicky Eaters, Feeding Interaction, Good Enough Parenting, Family Meals, Emotional Eating Prevention
-
The University of Hong KongHospital Authority, Hong KongCompleted
-
Medical University of South CarolinaCompleted
-
University of East LondonCompletedInfant Mental HealthUnited Kingdom
-
Karolinska InstitutetUnknownMother-child Relationship DisturbancesSweden