Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
Infant Outcomes and Depression Treatment in Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Depression is a serious illness that affects a person's body, mood, and thoughts. Researchers believe that it is one of the most common complications during and after pregnancy. The following symptoms may be signs of depression during pregnancy: 2 or more weeks of depressed mood; decreased interest or pleasure in activities; change in appetite or sleep patterns; fatigue or decreased energy; difficulty concentrating; excessive feelings of guilt or worthlessness; thoughts of suicide; and extreme restlessness or irritability. Depression is difficult to diagnose during pregnancy because its symptoms are sometimes confused with those of pregnancy. If left untreated, depression during pregnancy may affect not only the mother, but also the baby. Specifically, the hormone changes brought on by depression may contribute to premature and low-birth-weight infants. Interpersonal psychotherapy (IPT) is a short-term talking therapy that has been proven to be effective in treating depression. 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.
This study is associated with a larger parent study. Participants in this open-label study may be recruited directly for this study or through the parent study. All participants will receive 16 sessions of IPT. Sessions will last approximately 50 minutes and will focus on achieving depression symptom remission by improving interpersonal functioning. The majority of IPT sessions will be held prior to delivery; up to four sessions may be held postpartum. No medication will be provided in this study, but women who are currently taking selective serotonin uptake inhibitors (SSRIs) at the time of study entry may continue taking their medication. Participants whose symptoms do not improve with IPT will be referred to their non-study physician for further evaluation, and may begin taking SSRI medication upon physician recommendation. The effects of both IPT and medication therapy will be considered when assessing outcomes. Study visits will occur at 28, 32, and 36 weeks gestation, as well as Weeks 1, 2, and 6, and Month 6 postpartum. Measurements will include cortisol levels, which will be obtained using a saliva sample, as well as depression symptom severity, which will be assessed at each IPT session. Blood samples will be taken as part of the parent study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Plans to move away from the area prior to giving birth
- Current use of steroids for medical conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
Participants will receive 16 sessions of interpersonal psychotherapy
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17)
Time Frame: Measured during pregnancy and the first 7 months after delivery
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Measured during pregnancy and the first 7 months after delivery
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Infant birth outcomes
Time Frame: Measured during the first 7 months after delivery
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Measured during the first 7 months after delivery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Biologic measures related to depression in both mothers and infants
Time Frame: Measured through 14 months fter delivery
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Measured through 14 months fter delivery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheila M. Marcus, MD, Universitiy of Michigan
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00007344
- DSIR 83-ATAS (NIMH Program Class Code)
- R21MH072673 (U.S. NIH Grant/Contract)
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