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

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT02371356
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 91,084
• Duration (Months): 60

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Preterm Delivery

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 91084 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jan 31, 2017
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Preterm Delivery [Through the end of pregnancy, an average of 40 weeks]

   Delivery prior to 37 completed weeks of gestational age

2. Low Birth Weight [Through the end of pregnancy, an average of 40 weeks]

   Birth weight <2500 grams

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Kaiser member

• Pregnant

Exclusion Criteria:

• Not a member of Kaiser Permanente

• Not pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kaiser Permanente
• Patient-Centered Outcomes Research Institute

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 1, 2013

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02371356
• Other Study ID Numbers: CN-13-1650-H
• First Posted: Feb 25, 2015
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Premature Birth; Depression; Depressive Disorder

Study Results

Participant Flow

Arm/Group Title	Depressed, Medication Only	Depressed, Psychotherapy Only	Depressed, Medication & Psychotherapy	Depressed, Untreated	Not Depressed
Arm/Group Description	Screen positive for depression and use only antidepressants during pregnancy	Screen positive for depression and receive psychotherapy only	Screen positive for depression and receive both antidepressants and psychotherapy	Screen positive for depression and receive no treatment	Screen negative for depression and received no treatment
Period Title: Overall Study
STARTED	1320	7354	2804	7423	72183
COMPLETED	1320	7354	2804	7423	72183
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Depressed, Medication Only	Depressed, Psychotherapy Only	Depressed, Medication & Psychotherapy	Depressed, Untreated	Not Depressed	Total
Arm/Group Description	Screen positive for depression and use only antidepressants during pregnancy	Screen positive for depression and receive psychotherapy only	Screen positive for depression and receive both antidepressants and psychotherapy	Screen positive for depression and receive no treatment	Screen negative for depression and received no treatment	Total of all reporting groups
Overall Participants	1320	7354	2804	7423	72183	91084
Age, Customized (Count of Participants)
18-24 years	156 11.8%	1792 24.4%	400 14.3%	1123 15.1%	8987 12.5%	12458 13.7%
25-34 years	721 54.6%	4117 56%	1654 59%	4440 59.8%	46148 63.9%	57080 62.7%
35+ years	443 33.6%	1445 19.6%	750 26.7%	1860 25.1%	17048 23.6%	21546 23.7%
Sex: Female, Male (Count of Participants)
Female	1320 100%	7354 100%	2804 100%	7423 100%	72183 100%	91084 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	813 61.6%	2638 35.9%	1610 57.4%	2257 30.4%	26385 36.6%	33703 37%
Asian	103 7.8%	1147 15.6%	165 5.9%	1957 26.4%	19697 27.3%	23069 25.3%
African-American	55 4.2%	945 12.9%	248 8.8%	577 7.8%	3773 5.2%	5598 6.1%
Hispanic	283 21.4%	2200 29.9%	621 22.1%	2208 29.7%	18545 25.7%	23857 26.2%
Other/multiple/unknown	66 5%	424 5.8%	160 5.7%	424 5.7%	3783 5.2%	4857 5.3%
Region of Enrollment (Count of Participants)
United States	1320 100%	7354 100%	2804 100%	7423 100%	72183 100%	91084 100%

Outcome Measures

1. Primary Outcome

Title	Preterm Delivery
Description	Delivery prior to 37 completed weeks of gestational age
Time Frame	Through the end of pregnancy, an average of 40 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depressed, Medication Only	Depressed, Psychotherapy Only	Depressed, Medication & Psychotherapy	Depressed, Untreated	Not Depressed
Arm/Group Description	Screen positive for depression and use only antidepressants during pregnancy	Screen positive for depression and receive psychotherapy only	Screen positive for depression and receive both antidepressants and psychotherapy	Screen positive for depression and receive no treatment	Screen negative for depression and received no treatment
Measure Participants	1320	7354	2804	7423	72183
Preterm	139 10.5%	556 7.6%	272 9.7%	569 7.7%	4164 5.8%
Not preterm	1181 89.5%	6798 92.4%	2532 90.3%	6854 92.3%	68019 94.2%

2. Primary Outcome

Title	Low Birth Weight
Description	Birth weight <2500 grams
Time Frame	Through the end of pregnancy, an average of 40 weeks

Outcome Measure Data

Analysis Population Description

Those with missing birth weight information were excluded from the analysis of low birth weight

Arm/Group Title	Depressed, Medication Only	Depressed, Psychotherapy Only	Depressed, Medication & Psychotherapy	Depressed, Untreated	Not Depressed
Arm/Group Description	Screen positive for depression and use only antidepressants during pregnancy	Screen positive for depression and receive psychotherapy only	Screen positive for depression and receive both antidepressants and psychotherapy	Screen positive for depression and receive no treatment	Screen negative for depression and received no treatment
Measure Participants	1308	7251	2778	7310	72073
Low birth weight	82 6.2%	408 5.5%	158 5.6%	385 5.2%	3154 4.4%
Not low birth weight	1226 92.9%	6843 93.1%	2620 93.4%	6925 93.3%	68919 95.5%

Adverse Events

Time Frame	Overall Study: Through the end of pregnancy, an average of 40 weeks
Arm/Group Title	Depressed, Medication Only		Depressed, Psychotherapy Only		Depressed, Medication & Psychotherapy		Depressed, Untreated		Not Depressed
Arm/Group Description	Screen positive for depression and use only antidepressants during pregnancy		Screen positive for depression and receive psychotherapy only		Screen positive for depression and receive both antidepressants and psychotherapy		Screen positive for depression and receive no treatment		Screen negative for depression and received no treatment
All Cause Mortality
	Depressed, Medication Only		Depressed, Psychotherapy Only		Depressed, Medication & Psychotherapy		Depressed, Untreated		Not Depressed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1320 (0%)		0/7354 (0%)		0/2804 (0%)		0/7423 (0%)		0/72183 (0%)
Serious Adverse Events
	Depressed, Medication Only		Depressed, Psychotherapy Only		Depressed, Medication & Psychotherapy		Depressed, Untreated		Not Depressed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1320 (0%)		0/7354 (0%)		0/2804 (0%)		0/7423 (0%)		0/72183 (0%)
Other (Not Including Serious) Adverse Events
	Depressed, Medication Only		Depressed, Psychotherapy Only		Depressed, Medication & Psychotherapy		Depressed, Untreated		Not Depressed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1320 (0%)		0/7354 (0%)		0/2804 (0%)		0/7423 (0%)		0/72183 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.