Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health

Study Overview
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Brief Summary
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Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments. We propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination. The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups. Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.

Detailed Description
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Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments. Kaiser Permanente Northern California has implemented a large scale universal peripartum depression screening program, annually screening more than 35,000 pregnant women. Taking advantage of this unique infrastructure, we propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination. The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups. Stakeholders (patients, advocacy groups, and providers) are an integral part of the research team. Four cohorts with different treatment options including untreated will be formed within each depression type (with or without comorbidity): (A) Antidepressant only: screen positive for depression and use only antidepressants during pregnancy; (B) Psychotherapy only: screen positive and receive psychotherapy only; (C) Combination therapy: screen positive and receive both antidepressants and psychotherapy; (D)Untreated depression: screen positive and receive no treatment. A total of eight cohorts will be formed. A final cohort (E) No depression: screen negative and receive no treatment, will be examined for baseline comparison. Information on depression treatment and PTD and LBW will be available for all participating women who will be followed until the end of pregnancy. Within each depression category, comparison of Cohort A, B & C to D, respectively, will determine if treating depression is effective. Pair-wise comparisons among Cohorts A, B & C will determine the comparative effectiveness of treatment regimens. Comparison of Cohort D to E provides baseline fetal risks of untreated depression. Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.

Official Title
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Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health

Conditions
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Depression, Preterm Delivery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kaiser member Pregnant Exclusion Criteria: Not a member of Kaiser Permanente Not pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Depressed, Medication only<br>Screen positive for depression and use only antidepressants during pregnancy | |
| Depressed, Psychotherapy only<br>Screen positive for depression and receive psychotherapy only. | |
| Depressed, Medication & Psychotherapy<br>Screen positive for depression and receive both antidepressants and psychotherapy. | |
| Depressed, untreated<br>Screen positive for depression and receive no treatment. | |
| Not depressed<br>Screen negative for depression and receive no treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Delivery | Delivery prior to 37 completed weeks of gestational age | Through the end of pregnancy, an average of 40 weeks | 
| Low Birth Weight | Birth weight <2500 grams | Through the end of pregnancy, an average of 40 weeks |