Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
Infant Outcomes and Depression Treatment in Pregnancy
3 other identifiers
interventional
120
1 country
1
Brief Summary
This study will evaluate the impact of interpersonal psychotherapy on the course of depression during and after pregnancy, as well as its effect on infant birth outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Oct 2006
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2006
CompletedFirst Posted
Study publicly available on registry
September 26, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedMay 30, 2013
May 1, 2013
2.8 years
September 22, 2006
May 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17)
Measured during pregnancy and the first 7 months after delivery
Infant birth outcomes
Measured during the first 7 months after delivery
Secondary Outcomes (1)
Biologic measures related to depression in both mothers and infants
Measured through 14 months fter delivery
Study Arms (1)
1
EXPERIMENTALParticipants will receive 16 sessions of interpersonal psychotherapy
Interventions
IPT sessions will address adjustment to pregnancy, concerns about interpersonal relationships, and parenting concerns. Sessions will be weekly, but may be determined by clinical desires of patient and therapist.
Eligibility Criteria
You may qualify if:
- No more than 28 weeks pregnant at the time of study entry
- History of depression or anxiety
- Current symptoms of distress
- Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS)
- English-speaking
You may not qualify if:
- Plans to move away from the area prior to giving birth
- Current use of steroids for medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheila M. Marcus, MD
Universitiy of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section Director Child & Adolescent Psychiatry
Study Record Dates
First Submitted
September 22, 2006
First Posted
September 26, 2006
Study Start
October 1, 2006
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
May 30, 2013
Record last verified: 2013-05