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

NCT ID: NCT02371356

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 91084 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-04-30

Brief Summary

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

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.

Conditions

Depression; Preterm Delivery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Depressed, Medication only

Screen positive for depression and use only antidepressants during pregnancy

No interventions assigned to this group

Depressed, Psychotherapy only

Screen positive for depression and receive psychotherapy only.

No interventions assigned to this group

Depressed, Medication & Psychotherapy

Screen positive for depression and receive both antidepressants and psychotherapy.

No interventions assigned to this group

Depressed, untreated

Screen positive for depression and receive no treatment.

No interventions assigned to this group

Not depressed

Screen negative for depression and receive no treatment.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Kaiser member
• Pregnant

Exclusion Criteria

• Not a member of Kaiser Permanente
• Not pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CN-13-1650-H

Identifier Type: -

Identifier Source: org_study_id