Improving Postpartum Mental Health and Healthy Lifestyle Behaviors in Women of Color Who Are Pregnant and Experiencing Depression, Anxiety, and Stress Through Group Prenatal Care: A Randomized Controlled Trial

Abstract

Introduction

A mental health epidemic exists in women of color who are pregnant, with alarming rates of depression and anxiety. Furthermore, the majority of these women do not receive treatment because of inadequate screening, mental health stigma, and lack of access to mental health care professionals. The purpose of this study was to evaluate the 6‐week and 6‐month postpartum effects of the Creating Opportunities for Personal Empowerment (COPE)‐Pregnancy (COPE‐P) program, administered by midwives, compared with a health promotion education program on mental health and healthy lifestyle behaviors and beliefs of Black and Hispanic women experiencing depression, anxiety, or stress.

Methods

The study was a longitudinal, 2‐group randomized controlled trial with 299 Black and Hispanic participants who screened high on depression, anxiety, or stress scales. In total, 41% of women screened met study eligibility criteria. Two 6‐session group prenatal care interventions—the COPE‐P cognitive‐behavioral skills‐building (CBSB) program and a health promotion with discussion attention control—were evaluated. Valid and reliable measures included the General Anxiety Disorder‐7 scale, Edinburgh Postnatal Depression Scale, Perceived Stress Scale, Healthy Lifestyle Beliefs Scale, and Healthy Lifestyle Behaviors Scale, which were assessed at baseline, postintervention, 6 weeks postpartum, and 6 months postpartum.

Results

Two‐way analyses of variance and longitudinal multilevel growth models assessed outcomes. Both groups demonstrated rapid, significant decreases in depression, anxiety, and stress (P <.001) over time through 6 months postpartum. Only the COPE‐P group's significant improvement in healthy lifestyle behaviors was sustained through 6 weeks postpartum (P <.001). Participants who completed more CBSB activities showed greater improvements in outcomes than all other participants.

Discussion

CBSB and health promotion content provided in group prenatal care by midwives decreased depression, anxiety, and stress that persisted through 6 months postpartum. CBSB programming sustained longer‐term improvements in healthy lifestyle beliefs and behaviors. Performing more CBSB activities led to greater improvements in outcomes. The study was registered at the US National Institutes of Health (ClinicalTrials.gov) (NCT03416010).

INTRODUCTION

A mental health epidemic across the United States is affecting women of color who are pregnant. Disparities are prevalent, with higher rates of depression and anxiety in women of color than in White women and less access to treatment. ¹ , ² , ³ , ⁴ Despite the US Preventive Services Task Force recommending screening for anxiety and depression in all women who are pregnant, ⁵ , ⁶ only a small percentage are screened. Even fewer women who are pregnant with depression and anxiety receive treatment because of stigma and shortages of mental health care providers. ⁷ , ⁸ , ⁹ , ¹⁰

QUICK POINTS

• ✦Disparities exist in mental health for women who are pregnant, who often do not obtain treatment because of a shortage of mental health care providers as well as stigma.
• ✦Group prenatal care with cognitive‐behavioral skills‐building (CBSB) or health promotion education can result in rapid reductions in depression, anxiety, and depression that sustain through 6 months postpartum.
• ✦The Creating Opportunities for Personal Empowerment‐Pregnancy (COPE‐P) program is an acceptable, efficacious CBSB intervention that reduces depression, anxiety, and stress as well as improves healthy lifestyle behaviors and beliefs that sustain through 6 weeks postpartum in women of color experiencing emotional distress.
• ✦Women who complete more COPE‐P CBSB activities have greater symptom reduction than those who receive health promotion education and those who complete fewer CBSB activities.
• ✦Integrating COPE‐P in either individual or group formats, in person or virtually, can improve mental health and healthy lifestyle behaviors for women of color who are pregnant.

Prenatal depression and anxiety have adverse impacts on women of color, their infants, and the health care system, with higher costs for increased use of services, including emergency room visits, extended hospital stays, and unplanned cesarean births. ¹¹ , ¹² , ¹³ As a result, developing evidence‐based interventions to improve mental health outcomes, especially in women of color who are pregnant, is a high national priority.

Creating Opportunities for Personal Empowerment (COPE) is a manualized 7‐session cognitive‐behavioral skills‐building (CBSB) program that can be administered by health care professionals with and without specialized mental health training (eg, nurse practitioners, family physicians, social workers). Findings from diverse populations have indicated that when COPE is provided weekly for 7 consecutive weeks, it decreases depression, anxiety, stress, and suicidal ideation as well as increases healthy lifestyle beliefs and behaviors. ¹⁴ , ¹⁵ , ¹⁶ , ¹⁷ , ¹⁸ , ¹⁹ , ²⁰ , ²¹ , ²² The COPE program was adapted for administration by midwives to women of color who are pregnant in a randomized controlled trial (RCT) and titled COPE‐Pregnancy (COPE‐P). Immediate postintervention findings revealed that both COPE‐P participants and those in an attention control group had significant declines in depression, anxiety, and stress as well as increases in healthy lifestyle beliefs and behaviors, but there were no significant differences between groups. ²³ This study aimed to evaluate outcomes at 6‐week and 6‐month postpartum assessments.

Conceptual Framework

The conceptual framework was cognitive‐behavioral theory (CBT), which posits that a person's thoughts affect their feelings and behaviors. ²⁴ A major root cause of depression and anxiety is automatic negative patterns of thinking and unhelpful beliefs (eg, “I can't do anything right,” “I'm not a good mother,” “engaging in healthy behaviors is hard”), which then lead to negative emotions (eg, depression, anxiety) and unhealthy behaviors (eg, emotional overeating, alcohol use). ²⁵ , ²⁶ By learning how to identify cognitive distortions, challenge them, and replace them with positive thoughts, mood improves, and one engages in healthy behaviors. ²⁷

Group prenatal care is an established—though relatively new—mode of prenatal care that decreases rates of preterm birth and increases patient satisfaction and knowledge about childbirth and contraception as well as breastfeeding initiation rates. ²⁸ However, findings on mental health outcomes vary. ²⁹ By nesting a CBT‐based program into group prenatal care, it was hypothesized that women of color would have better outcomes at 6 weeks and 6 months postpartum than women in an attention control group. It was also hypothesized that COPE‐P participants who engaged in more CBSB activities would have better outcomes than those who engaged in fewer.

METHODS

Study Team

Research design, data collection, and analysis were conducted by the authors, one of whom identifies as a person of color. Most authors have training in nursing and nurse‐midwifery. The first author is an emeritus professor and a psychiatric mental health care and pediatric nurse practitioner with expertise in intervention research, evidence‐based practice, mental health and well‐being, and CBSB interventions with at‐risk populations. She served as vice president for health promotion and chief wellness officer at a large Midwest university for 13 years. The second author is an internationally known perinatal nurse researcher and professor whose career has focused on maternal health in women of color spanning more than 25 years. Prior to this RCT, a pilot was conducted in consultation with an experienced community‐participatory researcher who identifies as a woman of color to tailor the intervention for cultural appropriateness and universal scalability.

Design

This study was a 2‐arm RCT in which one group received COPE‐P and the other received PregnancyPlus. PregnancyPlus was an attention control group and provided a match in time and attention: a health promotion education program similar to the intervention. Block randomization of groups in a 1:1 ratio was performed by a statistician who had no involvement in or access to participant recruitment. A target sample size of 364 total would have provided more than 80% power to detect small to moderate group differences in outcomes, testing at an α of.05 for all proposed models. To retain an analytic sample size of 364 with an anticipated 30% attrition rate, target enrollment was 500.

Survey data were collected using paper‐and‐pencil surveys, scanned with Remark software, and managed with Research Electronic Data Capture, a secure, web‐based software platform designed for research. ³⁰ The study was approved by the respective institutional review boards and registered at the US National Institutes of Health (ClinicalTrials.gov) (NCT03416010). The protocol has been published elsewhere. ³¹ Reporting of this study followed Consolidated Standards of Reporting Trials (CONSORT) 2025 guidelines (Supporting Information: Appendix S1). ³²

Sample

The study enrolled self‐identified Black or Hispanic women of color from 2018 to 2022 who met cutoff scores for elevated depressive, anxiety, or stress symptoms. See Tables 1 and 2 for inclusion and exclusion criteria. It took place at 2 urban locations, one Midwestern and one Northeastern. Participants were approached at scheduled prenatal visits for recruitment. During the most limiting COVID‐19 restriction periods, participants were referred to the program by their care provider and contacted by study staff by phone for recruitment. Times for this varied by site and institution policies. Participants completed the consent process prior to study activities and signed either written or electronic consent forms.

Table 1.

Study Inclusion and Exclusion Criteria

Inclusion Criteria	Exclusion Criteria
Between 18 and 40 years old	Chronic health conditions (eg, hypertension, diabetes)
An uncomplicated singleton pregnancy of <19 weeks (based on ultrasound or last menstrual period when ultrasound is not available)	Currently receiving treatment or therapy for a psychiatric diagnosis
Self‐identify as either Black or Hispanic	An answer of 2 or 3 on item 10 on the EPDS scale
Speak and read English (Midwest site) Speak and read English or Spanish (Northeast site)	Have participated in this study with a prior pregnancy
Meet criteria for screening scores (see Table 2)	Pregnancy complications, such as preeclampsia, gestational diabetes, or fetal abnormalities

Abbreviation: EPDS, Edinburgh Postnatal Depression Scale.

Table 2.

Study Inclusion and Exclusion Criteria: Validated Scale Results

Scale	Ineligible Scores	Eligible Scores	Additional Follow‐Up
GAD‐7	≤9	≥10
PSS	≤19	≥20
EPDS total	≤9	≥10	15+ requires referral to primary care provider and monitoring
EPDS #10 (self‐harm)	2 or 3	0 or 1	Scores >0 require immediate mental health follow‐up

Abbreviations: EPDS, Edinburgh Postnatal Depression Scale; GAD‐7, General Anxiety Disorder‐7; PSS, Perceived Stress Scale.

After providing informed consent, participants completed valid and reliable screening tools, the General Anxiety Disorder‐7 (GAD‐7) scale, Edinburgh Postnatal Depression Survey (EPDS), and the Perceived Stress Scale (PSS) to determine study eligibility (Table 2).

Group assignment occurred on a rolling basis. The target gestational age for session 1, regardless of study arm, was 16 (±2) weeks’ gestation. Participants who did not have any group members recruited by 19 weeks’ gestation were excluded from further participation.

Measures

Primary outcomes were depression, anxiety, stress, healthy lifestyle beliefs, and healthy lifestyle behaviors. For both groups, measures were assessed at enrollment (<19 weeks’ gestation), after the last group session (∼34 weeks’ gestation), 6 weeks postpartum, and 6 months postpartum.

Race and ethnicity were screened using information in electronic health records. Enrolled participants were asked to self‐identify their race as White, Black, or other. They were separately asked to self‐identify their ethnicity as “Hispanic/Latino,” “Non‐Hispanic/Latino,” or other. For each “Other” option, participants were able to write in their race or ethnicity.

GAD‐7 is a 7‐item, 4‐point Likert‐type scale ranging from not at all (0) to every day (3) that assesses the participants’ level of anxiety over the last 2 weeks. Scores range from 0 to 21, with higher scores indicating greater impairment from the participant's experience of anxiety. ³³ The range for mild anxiety is 5 to 9; moderate anxiety is 10 to 14, and severe anxiety is more than 15. The Cronbach's α with this sample was .89.

PSS is a 10‐item, 5‐point Likert‐type scale widely used as a standardized measure of global stress. Comparing the PSS with depression scores and life‐event scales in college samples supported concurrent and predictive validity. ³⁴ Scores range from 0 to 40, and the cutoffs for moderate stress are 14 to 26. ³⁵ The PSS has demonstrated internal consistency reliability of.80 with women of color who are pregnant. ³⁶ The Cronbach's α with this sample was .86.

EPDS is a 10‐item 4‐point self‐report perinatal depression questionnaire with scores ranging from 0 to 30, with higher scores signifying higher severity of depressive symptoms. ³⁷ , ³⁸ , ³⁹ , ⁴⁰ Participants described how they felt the previous week. The cutoff point for minor depression is 10 or greater, and moderate depression is 13 or greater. ³⁸ The Cronbach's α with this sample was .85.

The Healthy Lifestyle Beliefs Scale is a 16‐item, 5‐point Likert‐type scale ranging from 1 (strongly disagree) to 5 (strongly agree). It was adapted from other valid and reliable belief scales. ⁴¹ This scale taps beliefs about facets of maintaining a healthy lifestyle. The Cronbach's α with this sample was .90.

The Healthy Lifestyles Behaviors Scale is a 15‐item, 5‐point Likert‐type scale ranging from 1 (strongly disagree) to 5 (strongly agree). In our prior work, factor analysis supported construct validity. ⁴² The Cronbach's α with this sample was .90.

There are 6 skills‐building activities (SBAs) following each of the COPE‐P sessions. The number of sessions completed was summed as a dose measure. For dose‐effect evaluation, completion was set as a dichotomous variable with 2 groups: those who completed only half the activities, compared with those who completed 4 or more.

Program acceptability was assessed with a 21‐item, 5‐point Likert‐type scale ranging from 1 (strongly disagree) to 5 (strongly agree). The score is averaged, with higher scores indicating greater acceptability. Score range is 21 to 105. Sample items are “I would recommend COPE‐P to a friend,” and, “The group sessions held my attention and interest.”

Interventions

COPE‐P is a mindfulness‐integrated CBSB program that draws on all key CBT concepts (eg, cognitive reappraisal, positive self‐talk, goal setting, problem solving, coping with everyday stressors, communication, emotional regulation) and manualizes them for provision by midwives or other health care professionals. COPE‐P was adapted for provision in 6 prenatal group sessions, spaced out over longer time intervals than weekly to more closely align with the routine prenatal care schedule (see Table 3). Additional content to promote a healthy lifestyle was integrated into the sessions, including healthy eating and physical activity. Each COPE‐P session was followed by SBAs that helped participants put the session content into practice (eg, imagery, deep abdominal breathing, monitoring for emotional triggers, and dealing with stressful situations). Facilitators briefly introduced SBAs in sessions, and participants completed them independently between sessions. The first author trained facilitators on COPE‐P, and randomly selected sessions were assessed for fidelity.

Table 3.

Cognitive‐Behavioral Skills‐Building Content in the COPE‐P Program

Session 1	Thinking, feeling, behaving triangle
Session 2	Self‐esteem and positive self‐talk
Session 3	Stress and coping during pregnancy
Session 4	Planning, goal setting, and problem solving
Session 5	Dealing with emotions in healthy ways
Session 6	Coping with stressful situations during pregnancy

Abbreviation: COPE‐P, Creating Opportunities for Personal Empowerment‐Pregnancy.

PregnancyPlus, the attention control health promotion program, was also provided across 6 group prenatal care sessions in the same time frame (1.5 hours) as the COPE‐P intervention. Each session discussed an American College of Obstetricians and Gynecologists patient education pamphlet: (1) nutrition during pregnancy, (2) exercise during pregnancy, (3) obesity and pregnancy, (4) exercise after pregnancy, (5) breastfeeding your newborn, and (6) postpartum depression.

Both the PregnancyPlus and COPE‐P group prenatal care formats followed similar structures. Both had individual care with clinicians, followed by time with the whole group. Both had similar scripted openings regarding fetal development, milestones, and anticipatory guidance. Then, both programs transitioned into their respective content: COPE‐P groups followed the CBSB manual, and PregnancyPlus groups reviewed the specified ACOG pamphlet of the day. Both groups encouraged questions throughout but had a more structured provision format as opposed to more loosely facilitated sessions.

Protocol Changes

Two significant changes occurred to the study protocol. First, prior to enrollment, one study site became unable to participate. The study was initially intended to use midwives as the exclusive care providers. Because of recruitment challenges, additional sites were used, necessitating the inclusion of advanced practice nurses as well. Second, the onset of the COVID‐19 pandemic required the use of multiple care provision modes—in person and virtual—instead of all in‐person group sessions. Enrollment was halted before reaching the target enrollment because of constraints on the study timeline.

Analysis

Descriptive statistics (means and SDs for continuous data and frequencies and percentages for categorical data) summarize the sample's demographic characteristics. We estimated the internal consistency and validity of the 5 scales. All analyses were conducted as intention to treat, followed by per‐protocol analyses. Bivariate tests (eg, independent and dependent t tests and correlations) evaluated differences and longitudinal patterns of change over time and between relevant subgroups (eg, intervention groups and language groups) for significant differences in health outcomes (ie, anxiety, stress, and depressive symptoms; healthy lifestyle behaviors and beliefs). We conducted 2‐way analyses of variance (ANOVAs) and longitudinal multilevel growth models on the health outcome data. All analyses were performed using IBM SPSS Statistics, Version 29.

RESULTS

Sample Characteristics and Retention

There were 299 participants enrolled at baseline: 177 in COPE‐P and 122 in PregnancyPlus (see Table 4).

Table 4.

Baseline Demographic and Mental Health Characteristics

Variables	COPE‐P (n = 177)	Preg+ (n = 122)
Race/ethnicity, n (%)
Black a	104 (59.1)	64 (52.5)
Hispanic b	55 (31.3)	44 (36.1)
Black Hispanic	13 (7.4)	12 (9.8)
Mixed	4 (2.3)	2 (1.6)
Preferred language, n (%)
Both	13 (7.6)	8 (6.7)
English	142 (82.6)	105 (85.2)
Spanish	17 (9.9)	6 (5.0)
Education, n (%)
Eighth grade or less	5 (2.9)	3 (2.6)
Some high school	14 (8.1)	14 (12.1)
High school degree/certificate	76 (43.9)	62 (53.4)
Some college/higher education	49 (28.3)	12 (10.3)
Associate or bachelor's degree	29 (16.8)	25 (21.6)
Enrolled in school, n (%)
Enrolled	35 (20)	103 (85.1)
Not enrolled	140 (80)	18 (15.4)
Employment, n (%)
Employed	92 (52.6)	64 (52.5)
Not employed	83 (47.4)	58 (47.5)
Income, n (%)
≤$5000	49 (29.3)	33 (29.2)
$5001‐$20,000	45 (26.9)	36 (31.9)
$20,001‐$30,000	28 (16.8)	22 (19.5)
$30,001‐$40,000	25 (15.0)	11 (9.7)
≥$40,001	20 (12.0)	11 (9.7)
Relationship status, n (%)
Single	106 (60.6)	77 (63.6)
Married/long term relationship	64 (36.6)	38 (31.4)
Divorced/separated/widowed	5 (2.9)	6 (5.9)
Health outcomes, mean (SD)
GAD‐7	9.27 (4.48)	8.35 (4.02)
PSS	22.48 (4.75)	21.95 (5.33)
EPDS	13.51 (4.43)	12.99 (3.90)
Health beliefs	59.64 (6.84)	59.52 (7.32)
Health behaviors	50.35 (8.97)	50.22 (8.78)
Age, mean (SD)	26.41 (5.28)	26.23 (5.25)

Abbreviations: EPDS, Edinburgh Postnatal Depression Scale; GAD‐7, General Anxiety Disorder‐7; Preg+, PregnancyPlus; PSS, Perceived Stress Scale.

^aThose who self‐identified as Hispanic but did not identify with race categories provided.

^bThose who self‐identified as Black but did not identify within ethnicity categories provided.

Attrition between baseline and postintervention was 36.1% (n = 108), followed by minor additional loss at 6 weeks postpartum (3.0%) and 6 months postpartum (2.5%). Attrition did not differ by intervention group or demographic characteristics. Participants lost to follow‐up were more likely to have annual household incomes of less than $5000 (χ², 19.73; P <.001). The CONSORT diagram (Figure 1) summarizes participant flow.

Figure 1.

CONSORT Participant Flow Diagram

Abbreviations: CONSORT, Consolidated Standards of Reporting Trials; COPE‐P, Creating Opportunities for Personal Empowerment‐Pregnancy; LTFU, lost to follow‐up.

Adapted from Schulz. ⁴³

Psychometric Properties

All scales were psychometrically tested. Before testing intervention effects, the reliability and validity of the outcome measures were confirmed. Reliability estimates from Cronbach's α ranged from.85 to.90, and there was evidence of validity with correlations appropriate in magnitude and direction (see Table 5). Correlations among outcomes were in the expected directions and magnitudes, supporting validity. Depression, anxiety, and stress were positively correlated (r, 0.69‐0.78), whereas these outcomes were moderately and negatively associated with healthy lifestyle beliefs and behaviors (r, –0.25 to –0.47).

Table 5.

Correlations Averaged Across Time Points Among Health Outcomes Stratified by Intervention

Scale	Anxiety	Depression	Stress	Healthy Behaviors	Healthy Beliefs
Anxiety	1
Depression	0.706	1
Stress	0.693	0.778	1
Healthy behaviors	−0.251	−0.303	−0.401	1
Healthy beliefs	−0.303	−0.384	−0.471	0.697	1

All correlations are P <.001.

Primary Outcomes

Two‐way repeated‐measures ANOVAs and multilevel growth models examined changes in outcomes over time and across groups. Across all participants, there were significant improvements over time in anxiety, depression, and stress (P <.001 for all), with no significant differences between COPE‐P and PregnancyPlus or time × group interactions. Mean symptom reductions from baseline to 6 months postpartum represented large within‐group effects (Cohen's d, 0.9‐1.1), indicating clinically meaningful declines in emotional distress.

Healthy lifestyle beliefs and behaviors also improved significantly over time for both groups (P <.001). For healthy beliefs, a transient between‐group difference emerged at 6 weeks postpartum, favoring COPE‐P (F _1,683, 6.89; P = .009). Participants in COPE‐P maintained gains in healthy beliefs through 6 weeks postpartum, whereas those in PregnancyPlus showed a modest decline after birth. For healthy lifestyle behaviors, there was a significant overall time effect (P <.001) and a small but significant main effect of intervention group (F _1,681, 5.05; P = .025), with COPE‐P participants reporting greater behavioral improvement sustained through 6 weeks postpartum. There were no significant interactions (time × group).

Figures 2, 3, 4, 5, 6 illustrate decreases in mental health variables: anxiety, depression, and stress over time for both the COPE‐P and PregnancyPlus groups and increases in healthy beliefs and behaviors over time. On average, participants in COPE‐P sustained improvements in healthy lifestyle beliefs through 6 weeks postpartum, whereas the PregnancyPlus group did not. Healthy lifestyle behaviors increased in both groups from preintervention to postintervention, but only in the COPE‐P group were these increases sustained through 6 weeks postpartum. Multilevel growth‐curve models with random participant intercepts confirmed these patterns. Time remained a significant predictor of improvement across all outcomes (P <.001), but group and time × group effects were not significant after controlling for demographic characteristics. These models verified that both interventions were associated with significant longitudinal decreases in distress and increases in health‐promoting cognitions and behaviors.

Figure 2.

Anxiety Over Time, Stratified by Intervention Group

Abbreviations: COPE‐P, Creating Opportunities for Personal Empowerment‐Pregnancy; PP, PregnancyPlus.

Figure 3.

Depression Over Time, Stratified by Intervention Group

Abbreviations: COPE‐P, Creating Opportunities for Personal Empowerment‐Pregnancy; PP, PregnancyPlus.

Figure 4.

Stress Over Time, Stratified by Intervention

Abbreviations: COPE‐P, Creating Opportunities for Personal Empowerment‐Pregnancy; PP, PregnancyPlus.

Figure 5.

Health Beliefs Over Time, Stratified by Intervention Group

Abbreviations: COPE‐P, Creating Opportunities for Personal Empowerment‐Pregnancy; PP, PregnancyPlus.

Figure 6.

Health Behaviors Over Time, Stratified by Intervention Group

Abbreviations: COPE‐P, Creating Opportunities for Personal Empowerment‐Pregnancy; PP, PregnancyPlus.

Dose‐Response Effects

To examine the dose effect for COPE‐P, we compared those who completed 4 or more of the 6 SBAs (more SBAs), 3 or fewer of the 6 SBAs (fewer SBAs), and PregnancyPlus participants (see Table 6). Postintervention, there was a statistically significant difference in stress. Those who had completed more SBAs (mean, 13.83; SD, 6.25) reported significantly lower stress than did the PregnancyPlus group (mean, 21.86; SD, 6.01; F _{(2, 163)}, 2.88; P = .048). At 6 months postpartum, those who had completed more SBAs (mean, 2.76; SD, 3.29) reported significantly lower anxiety than those who completed fewer SBAs (mean, 5.16; SD, 5.03) and the PregnancyPlus group (mean, 3.53; SD, 4.05; F _{(2, 144)}, 3.56; P = .031). Finally, only those who had completed more SBAs (mean, 5.12; SD, 5.63) reported significantly lower depression than those who completed fewer SBAs (mean, 7.80; SD, 5.75; F _{(2, 144)}, 2.78; P = .048).

Table 6.

Effects of the COPE‐P Intervention Dosage on Mental Health

	Time Point 1		Time Point 2		Time Point 3
Effects	Mean (SD)	F‐Test Statistic	Mean (SD)	F‐Test Statistic	Mean (SD)	F‐Test Statistic
Stress: more SBAs	13.83 (6.25)	F (2, 163) = 2.88, P = .048 c	10.85 (8.35)	F (2, 149) = 0.234, P = .100	12.84 (7.50)	F (2, 144) = 0.899, P = .409
Stress: fewer SBAs	16.31 (6.36)		14.10 (6.65)		15.03 (6.98)
Stress: PregnancyPlus	21.86 (6.01)		12.46 (6.62)		14.06 (7.54)
Anxiety: more SBAs	4.93 (4.76)	F (2, 163) = 4.02, P = .663	3.07 (3.32)	F (2, 149) = 2.11, P = .125	2.76 (3.29)	F (2, 144) = 3.56, P = .031 a
Anxiety: fewer SBAs	5.42 (3.85)		4.51 (4.68)		5.16 (5.03)
Anxiety: PregnancyPlus	5.45 (4.90)		3.19 (3.44)		3.53 (4.05)
Depression: more SBAs	7.00 (4.53)	F (2, 163) = 0.711, P = .493	5.52 (5.76)	F (2, 149) = 0.651, P = .523	5.12 (5.63)	F (2, 144) = 2.78, P = .048 b
Depression: fewer SBAs	7.87 (4.88)		6.80 (5.46)		7.80 (5.75)
Depression: PregnancyPlus	7.00 (4.46)		6.08 (4.86)		6.55 (4.63)

Abbreviations: COPE‐P, Creating Opportunities for Personal Empowerment‐Pregnancy; SBA, skills‐building activity.

^aCOPE‐P more SBAs was significantly lower than PregnancyPlus and COPE‐P fewer SBAs on anxiety.

^bCOPE‐P more SBAs was significantly lower than COPE‐P fewer SBAs on depression.

^cCOPE‐P more SBAs was significantly lower than PregnancyPlus on stress.

Provision Mode

Because of the COVID‐19 pandemic, provision of the interventions had to be reconfigured. Participants were classified per their provision method: (1) entirely in person (n = 35), (2) entirely virtual (n = 34), and (3) having had a mixture of in person and virtual (n = 95). We fit 2‐way ANOVA models to all health outcomes at all time points and tested for interaction between provision mode and the intervention. The only significant difference occurred at postintervention in anxiety by provision mode. The virtual group reported significantly greater anxiety (mean, 6.49; SD, 4.88) than did the mixed‐format group (mean, 3.97; SD, 2.90; F _(2,163), 3.23; P = .042; η²,.038). The in‐person group did not differ significantly from the other groups (mean, 5.63; SD, 4.48).

Evaluation

COPE‐P participants completed feedback on the intervention. On a 5‐point scale, they rated COPE‐P's acceptability with a mean of 4.51 (SD, 0.41). Participants reported that “The skills‐building exercises were very helpful because it showed me how to deal with negative things in a more positive way,” “They helped me understand stuff I should take more seriously, such as eating healthier and exercising more,” and “They were helpful because it gave various ideas on how to cope with everyday struggles.”

DISCUSSION

Both groups showed large statistically significant rapid decreases in depression, anxiety, and stress throughout pregnancy that were sustained into the postpartum period during COVID‐19, when these levels in women who were pregnant were much higher. ¹ , ⁴⁴ Findings from this trial indicate a positive dose‐response relationship between engagement in COPE‐P SBAs and improved mental health outcomes. Participants completing at least 4 SBAs experienced significantly lower anxiety, stress, and depression, indicating a positive dose‐response relationship.

Recent evidence suggests that mood during pregnancy is relatively stable but U‐shaped throughout pregnancy, with depression and anxiety increasing slightly but steadily postpartum. ⁴⁵ , ⁴⁶ Notably, these studies reflect the full spectrum of participants who were pregnant, not a subset with elevated scores in early pregnancy. These changes were not observed in either group in our study. Clinically, both groups met upper‐end cutoffs for minor depression and mild anxiety at enrollment, dropped postintervention, and had minimal symptoms through 6 months postpartum. Regarding stress, both groups started at the moderate level, dropped to below moderate 6 weeks postpartum, and rose just to the moderate stress cutoff at 6 months postpartum. The magnitude of within‐group improvements on women's mental health outcomes indicates that participation in structured group prenatal programming was beneficial in this study. However, a recent retrospective analysis comparing postpartum depression rates in Black and Hispanic women, regardless of their initial mental health status, in group prenatal care versus traditional individual care did not find a difference between groups in postpartum depression rates. ⁴⁷ Because both COPE‐P and PregnancyPlus groups experienced significant and clinically meaningful improvements from high to low mental health symptoms, detecting incremental between‐group differences became statistically challenging, especially when the PregnancyPlus program was an active control program that provided structured health promotion education, consistent contact with a midwife, and group interaction, rather than a usual care control condition. In addition, floor effects typically constrained the ability to detect between‐group differences because symptom variance was limited once both groups experienced substantial improvements. ⁴⁸ Unlike findings for the mental health variables, the COPE‐P group had significantly higher healthy lifestyle beliefs and behaviors than the PregnancyPlus group, whose beliefs and behaviors showed a modest postbirth decline 6 weeks postpartum. These outcomes are less subject to floor effects and suggest that CBT‐based skills‐building, including goal setting, communication, and problem solving, may be especially applicable to behavioral self‐regulation during the postpartum transition, a time when women experience fatigue, role strain, and competing demands. A booster intervention provided at 6 weeks postpartum may sustain these effects through 6 months postpartum and beyond.

COPE‐P was adapted from the original 7‐session COPE program, which focuses heavily on CBT‐based skills acquisition and practice, and condensed to 6 sessions that also included nutrition and physical activity to align with prenatal care priorities. This adaptation, which also administered the sessions at longer intervals than weekly sessions, reduced the intensity and repetition of CBSB. Findings from past studies have indicated that consistent practice of CBT‐based skills is key for improved outcomes. ⁴⁹ In this study, women who completed more of the COPE‐P SBAs reported significantly lower anxiety than the PregnancyPlus group and those who completed fewer SBAs. Regarding depression, those who completed more SBAs had fewer depressive symptoms than those completing fewer, highlighting the importance of completing the SBAs in the program and putting what is being learned into active practice for behavioral change. Findings from a recent pilot study that tested a 7‐session COPE‐P program in a telehealth provision format with individual women who were pregnant and depressed or anxious indicated significant reductions in depressive and anxiety symptoms as well as significant improvements in healthy lifestyle beliefs and behaviors, ⁵⁰ which is consistent with prior COPE studies. ¹⁴ , ¹⁵ , ¹⁶ , ¹⁷ , ¹⁸ , ¹⁹ , ²⁰ , ²¹ , ²² Another pilot study testing a 7‐session group COPE‐P program in women of low socioeconomic status in Portugal also showed statistically significant improvements in anxiety, depression, and healthy lifestyle behaviors postintervention, with all but depression remaining significant through 6 weeks postpartum when provided either in person or virtually. ⁵¹

It is important to note that group prenatal care was not acceptable to some participants who discontinued the study prior to beginning group sessions because of scheduling difficulties, concerns that their partner could not attend, issues with changing providers, and other undisclosed reasons. This highlights the importance of offering a variety of evidence‐based interventions to address the spectrum of preferences in the large number of women who are not receiving any mental health care treatment.

This study adds to the body of literature supporting the positive outcomes of group prenatal care in women of color with mental health symptoms. Manualized CBSB interventions, provided by prenatal clinicians, are an acceptable intervention for women of color with mild to moderate anxiety or depressive symptoms and align with the midwifery model of care.

Limitations

The COVID‐19 pandemic introduced factors that may have impacted outcomes in this RCT. COVID‐19 itself adversely impacted maternal mental health with spikes in depression and anxiety during pregnancy and postpartum. ¹ , ⁴⁴ This study was midrecruitment when the pandemic hit, causing disruptions in recruitment and changes in the format of sessions from group in person to a virtual format, which may have impacted outcomes. Although the measures used were valid and reliable, all were self‐report, which may have introduced bias.

Two factors contributed to an imbalance in study arms at baseline. First, study recruitment did not reach the goal of 500 participants. Recruitment was terminated based on time requirements for participants to complete the study, not a specific end point that would balance the arm assignments. Second, random assignment was completed by group number, not individual participant. Group numbers were randomly assigned to either PregnancyPlus or COPE‐P. All participants within a gestational age window were assigned to a corresponding group number. Group size varied according to the number of eligible participants recruited in each gestational age window.

Attrition was also a challenge that could have impacted outcomes. The largest source of attrition occurred from recruitment to time point 1 (Figure 1). The transition to telehealth during COVID‐19 may have impacted participant engagement in sessions. Additionally, although standard precautions were used, fear of disease exposure and risk to both woman and fetus may have impacted the desire to attend group care. As noted above, the group prenatal care model itself also impacted retention.

Future Research

A future full‐scale RCT of the 7‐session weekly COPE‐P program is needed to determine both the prenatal and postpartum impact of the individually provided, weekly, telehealth COPE‐P intervention. In addition, another trial with COPE‐P and a pure control group (ie, standard care) is warranted. Testing methods to strengthen completion of CBT‐based SBAs in COPE‐P is important. In addition, it would be interesting to test a CBT‐based booster at the 6‐week postpartum visit and study the intervention effects for a longer period, assessing both maternal and infant outcomes.

CONCLUSION

COPE‐P and PregnancyPlus both produced meaningful, rapid improvements in Black and Hispanic women's mental health that were sustained through 6 months postpartum. Women who completed more COPE‐P SBAs had better mental health outcomes than both participants who completed fewer and those in the PregnancyPlus group. COPE‐P demonstrated added value in sustaining healthy lifestyle beliefs and behaviors through the early postpartum period. Use of manualized CBSB programs in group prenatal care could improve outcomes for a high‐risk population while maintaining continuity of care. Completing the SBAs following the sessions is key to the best outcomes. The COPE‐P program, with its potential to reduce disparities in mental health care and improve healthy lifestyle behaviors that sustain through the early postpartum period, offers another tool for midwives and other health care professionals caring for women of color who are pregnant and disproportionately affected by the current mental health epidemic across the United States.

CONFLICT OF INTEREST

Bernadette Mazurek Melnyk owns a company, COPE2Thrive, LLC, which disseminates other versions of the COPE program. All other authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Supporting information

Appendix S1. Consolidated Standards of Reporting Trials (CONSORT) Checklist