Lit Review (Results Section)

ORIGINAL ARTICLE

An intervention to reduce postpartum depressive symptoms: a randomized controlled trial

Elizabeth A. Howell & Susan Bodnar-Deren & Amy Balbierz & Holly Loudon & Pablo A. Mora & Caron Zlotnick & Jason Wang & Howard Leventhal

Received: 1 May 2013 /Accepted: 27 August 2013 /Published online: 10 September 2013 # Springer-Verlag Wien 2013

Abstract Depressive symptoms and depression are a com- mon complication of childbirth, and a growing body of liter- ature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational

intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high-income mothers in a second randomized trial. Mothers in the intervention arm received a two-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depres- sive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3 weeks, 3 months, and 6 months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum was unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention versus en- hanced usual care posthospitalization: 3 weeks (6.0 vs. 5.6 %, p =0.83), 3 months (5.1 vs. 6.5%, p =0.53), and 6 months (3.6 vs. 4.6 %, p =0.53).

Keywords Postpartum depression . Randomized trial .

Behavioral intervention . Psychosocial

Introduction

Depressive symptoms and depression are one of the most common complications of childbirth and are the leading cause of disease-related disability among women (Gaynes et al. 2005; Kessler 2003). Estimates of prevalence rates for these symp- toms range from 10 to over 50 % depending on the screening instrument used and the population studied (Beeghly et al. 2003; Vera et al. 1991; Zayas et al. 2002). Symptoms of distress and depression impact hundreds of thousands of women annu- ally in the USA and affect women from all racial/ethnic and socioeconomic backgrounds. Both major depressive disorder

Supported by the National Institute of Mental Health (5R01MH77683) and the National Institute on Minority Health and Health Disparities (5P60MD000270).

Clinical trial registration Clinicaltrials.gov, www.clinicaltrials.gov, NCT00951717

E. A. Howell (*) : S. Bodnar-Deren :A. Balbierz : J. Wang Department of Health Evidence and Policy, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1077, New York, NY 10029-6574, USA e-mail: [email protected]

E. A. Howell :H. Loudon Department of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY, USA

E. A. Howell Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA

P. A. Mora PsychologyDepartment, University of Texas at Arlington, Arlington, USA

C. Zlotnick Department of Psychiatry and Human Behavior, Warren Alpert Brown Medical School, Women and Infants Hospital, Providence, RI, USA

H. Leventhal Institute for Health, Health Care Policy and Aging Research and Department of Psychology, Rutgers, the State University of New Jersey, New Brunswick, NJ, USA

S. Bodnar-Deren Department of Sociology, Virginia Commonwealth University, 923 W. Franklin Street, Office 509, Richmond, VA 23284-2040, USA

Arch Womens Ment Health (2014) 17:57–63 DOI 10.1007/s00737-013-0381-8

and moderate symptoms of depression negatively affect the quality of life and daily functioning of mothers (Josefsson et al. 2002). Whether these symptoms do or do not reach the level of diagnosed major depressive disorder, they are associ- ated with multiple, negative consequences for mothers and infants (Dennis and Ross 2005; Duer et al. 1988; Herrera et al. 2004; Kroenke et al. 2001, 2003; Matthey et al. 2000; McLearn et al. 2006;Minkovitz et al. 2005; Seguin et al. 1999).

A growing body of literature suggests that potentially modi- fiable factors are associated with depressive symptoms postpar- tum. Situational factors such as postpartum physical symptoms, infant colic, overload from daily demands, and poor social support are associated with and likely trigger depressive symp- toms (Howell et al. 2005, 2006, 2009, 2010). We hypothesized that one or more of the three subsets of depressive symptoms, e.g., somatic, mood, and self-critical component, could be trig- gered and moderated by situational stimuli and that an interven- tion designed to normalize the postpartum experience would lower rates of these symptoms. The intervention had three ob- jectives: (1) to clarify the immediate postpartum experience as “normal,” i.e., shared event (e.g., physical symptoms and infant and social demands); (2) to provide simple procedures for man- agement and enhancing social support; and (3) to define the time frame for recovery. A randomized trial testing this intervention showed a significant reduction in positive depression screens among self-identified black and Latina postpartum mothers for up to 6 months of follow-up (Howell et al. 2012).

In this report, we present the results of a second randomized controlled trial testing this intervention among a different sociodemographic cohort of women: white and Asian mothers.

Methods

Study sample

Participants included 540 self-identified white and Asian postpartum mothers who delivered between July 2009 and April 2010 at a large tertiary inner-city hospital located in East Harlem, New York City. An earlier trial had recruited black and Latina postpartum mothers, and therefore, only white and Asian (non-black and non-Latina) women were in- cluded in this trial. The Program for the Protection of Human Subjects (the Institutional Review Board) at Mount Sinai School of Medicine approved this study. Eligible partic- ipants were ≥18 years of age and had infants with birth weights ≥2,500 g and 5-min Apgar scores ≥7. Women were identified by an electronic delivery system which includes information on maternal race/ethnicity, maternal age, infant Apgar scores, and infant birth weight.

Mothers whomet initial requirements were deemed eligible if they then self-identified as white, Asian, or other (non-black and non-Latina) minority women when questioned by a clinical

research coordinator. The clinical research coordinator approached mothers in hospital between their delivery day and postpartumday 2; approximately 12 to 17 patients were recruited Mondays through Fridays each week. Mothers who consented completed a 20-min survey and were assigned to intervention or enhanced usual care. Assignment involved giving each patient a number between 1 and 20, based on the order of delivery date, and using a list that had randomly assigned these numbers to intervention and control; the computer randomized list was prepared by the project statistician. The methods were similar to but completely separate from the trial with black and Latina mothers initiated 4 months earlier (Howell et al. 2012).

Intervention

Patients randomized to the intervention arm were given a two- step behavioral educational intervention. The theoretical un- derpinning of the intervention was based on the Common- Sense Model (CSM), a model that describes how patients automatically match and consciously interpret changes from their normal physical self to beliefs that theymay be acutely or chronically ill or merely tired or out of sorts (Leventhal et al. 2011;McAndrew et al. 2008). The interpretive process creates expectations about the likely duration of the current state and its consequences for daily activities and motivates action to return to normal, e.g., take a home remedy, seek care. The dramatic changes (e.g., in shape and weight, etc.) that occur postpartum can encourage a mother to see herself in her normal prepregnant state, a perception that will create unreal- istic expectations as to how she should feel and how quickly she should fully recover. These perceptions can encourage premature efforts to return to prepregnancy levels of activity, and failure to meet expectations can create depressive symp- toms. Our behavioral educational intervention was designed to address these potentially modifiable interpretations. It did so by preparing mothers to interpret and normalize triggers of depressive symptoms (e.g., vaginal bleeding, breast pain, etc.), and specified the need to bolster social support and conserve personal resources. Specific, simple actions were suggested to address each of these issues, e.g., symptoms and social needs; realistic time frames were provided for return to normal; and resources were listed in the event prob- lems exceeded specified time lines.

The in-hospital component of the two-step intervention involved a 15-min, in-hospital review of a patient education pamphlet and partner summary sheet by the mother with a masters-trained social worker. The patient education pamphlet described common postpartum physical symptoms, depres- sion, infant colic, and the importance of social support. The partner summary sheet described symptoms of depression and danger signs and gave partner suggestions of ways to help new moms. The second component of the intervention was a 2-week postdelivery call in which the social worker assessed

58 E.A. Howell et al.

patients' symptoms, skills in symptommanagement, and other needs. Fidelity of the intervention was maintained by repeated training and review of scripts for both the in-hospital and telephone components of the intervention. Approximately 5 % of both in-hospital sessions and 2-week telephone needs assessments were observed by a physician or project manager on the team. A coinvestigator or project manager shadowed each social worker, completed an intervention monitoring instrument, and shared the results of the assessment with the social worker and investigative team.

Enhanced usual care patients received routine postpartum hospital education (i.e., discharge materials, television educa- tional programs on infant care, breastfeeding, and peripartum care). To insure equivalent contact, patients assigned to en- hanced usual care received a 2-week postdelivery call to inform them of future surveys, and a list of health-related and community resources was mailed to them. The interven- tion materials were modified to represent white and Asian mothers but were identical in content and based on the same theoretical model (Howell et al. 2012). All materials were written at a sixth grade reading level and included pictorials. Interviewers were blinded to study arm assignment. All study participants were interviewed by phone at 3 weeks (mean days=27.2, SD 5.6; median days=26, range of 17 to 52), 3 months (mean days=84.3, SD 7.9; median days=81, range of 76 to 124), and 6 months (mean days=175.5, SD 8.7; median days=174, range of 162 to 218) to assess depressive symptoms and contributing and buffering factors.

Outcome variable

Postnatal depressive symptoms were assessed using the ten- item Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a commonly used postpartum depression screening instrument and has been validated in many postpartum popu- lations and different languages (Areias et al. 1996; Boyce et al. 1993; Carpiniello et al. 1997; Cox et al. 1987; Eberhard-Gran et al. 2001a, b; Ghubash et al. 1997; Harris et al. 1989; Jadresic et al. 1995; Lawrie et al. 1998; Lundh and Gyllang 1993; Murray and Carothers 1990; Wickberg and Hwang 1996; Zelkowitz and Milet 1995). The recommended cutoff score of ≥10 has sensitivities of 0.59–0.81, and specificities ranged from 0.77 to 0.88 for major and minor depression (Gaynes et al. 2005). The Patient Health Questionnaire-9 (PHQ-9) was also administered, and a comparison was made between the EPDS and PHQ-9 scores over time in a secondary analysis. Women reporting high levels of depressive symp- toms (EPDS ≥13 or PHQ-9 ≥20 or suicidal ideation) at any of the four assessments were referred for psychiatric assessment and possible treatment. They were retained in the study.

Survey items also included questions on sociodemographics, clinical characteristics such as antepartum complications, co- morbid conditions (e.g., diabetes, hypertension, asthma, thyroid

disease, heart disease), past depression history, anxiety, social support, and health-care factors. Medical charts were reviewed for parity, delivery type, insurance, past medical history, mater- nal complications, delivery complications, and infant outcomes.

Sample size was powered to detect a clinically meaningful difference in reduction of symptoms of postpartum depression 3 weeks postrandomization for women in the intervention arm in comparison with women in enhanced usual care. Assuming that 34 % of white (non-black and non-Latina) women would report depressive symptoms (EPDS≥10) in enhanced usual care (based on our prior research) (Howell et al. 2006), our recruitment target of 492 patients (246 per arm) met 90 % power based on a two-sided 0.05-level chi-squared test to detect a clinically meaningful 13 % reduction in depressive symptoms (from 34 to 21 %, a relative risk reduction of about 33 %). To allow for decreased power due to patient loss at follow-up, we planned to enroll 540 participants.

Data analysis

Data were collected in person at baseline and by telephone during follow-up interviews by clinical research coordinators blinded to intervention status. Participants in the intervention arm (N =270) and enhanced usual care (N =270) were com- pared at baseline on demographic and clinical characteristics using t tests and their nonparametric equivalents, chi-square tests, as appropriate. Group differences were summarized by 95 % confidence interval estimates. Overall study attrition rate was low and equivalent across treatment groups. The amount of missing data for our primary outcome measure, EPDS, was low at 3 weeks (7 %; 40/540), 3 months (14 %; 73/540), and 6 months (13 %; 72/540) and similar between groups at each time point. The primary analysis examined the efficacy of the intervention in reducing the likelihood of positive postpartum depression screens. Logistic regression analyses tested the effect of the intervention on positive depression screens at 3 weeks, 3months, and 6months postpartum. To assess change over time across groups for the primary outcome, generalized estimating equations (GEEs), a widely used method for analyzing corre- lated, longitudinal outcome data with statistical accuracy, were employed (Zeger and Liang 1986). Significance level of 0.05 was used for the primary outcome of postpartum depression, and the final model was adjusted for baseline depression screen.

Results

There were 4,448 deliveries over the study period, and 2,628 met the initial eligibility criteria (i.e., were ≥18, etc.). A random sample of 734 (28 %) of the 2,628 eligible mothers were approached in hospital and reviewed the study consent form. Of the 734mothers, 540 (73.6%) completed the consent process and were enrolled in the trial; 194 (26.4 %) had

An intervention to reduce postpartum depressive symptoms 59

declined participation (Fig. 1). Mothers who declined to par- ticipate were slightly younger than mothers who consented (mean age of 32 vs. 33; p <0.05). Of the 270 mothers ran- domized to the intervention arm, 262 received the intervention in hospital. Eight mothers were discharged before the social worker could meet with them. These eight patients were sent the education materials, and the social worker reviewed the educational materials over the phone. Eighty-nine percent (241/270) of the intervention group and 93 % (252/270) of the control group were successfully reached for the 2-week calls. Of the 540 enrolled patients, 16 patients withdrew over the 6-month study period. Completion rates for the follow-up interviews were 93% (500/540) at 3 weeks, 86% (467/540) at 3 months, and 86 % (467/540) at 6 months. Follow-up was equivalent for intervention and control at 3 weeks (92.2 vs. 93.0 %, p =0.74), at 3 months (87.0 vs. 85.9 %, p =0.71), and at 6 months postpartum (84.8 vs. 88.2 %, p =0.26). There were baseline differences in rates of positive depression screens between women lost to follow-up versus those includ- ed in the analyses at 3 weeks: 30% (12/40) lost to follow-up at 3 weeks screened positive versus 11 % (57/500) who com- pleted the 3-week survey.

The overall mean age of enrolled participants was 33 (range 18–48); 89 % were white, 9 % were Asian, 2.4 % had Medicaid insurance, 11 % earned ≤$30,000 annually, and 24 % were foreign born. Baseline characteristics of the inter- vention and control groups are described in Table 1. There were no clinically important differences between the two groups at baseline. The mean EPDS scores at baseline were 4.0 (SD 4.0; range 0–22) in the intervention group and 5.0 (SD 4.0; range 0–19) in the control group.

In the intention-to-treat analysis (N =540), there was no difference in positive depression screens among mothers in the intervention arm versus those in the control arm: at 3 weeks, 6.0 % (15/249) versus 5.6 % (14/251), p =0.83, respectively; at 3 months, 5.1 % (12/235) versus 6.5 % (15/232), p =0.53, respectively; and at 6 months, 3.5 % (8/230) versus 4.6 % (11/238), p =0.53, respectively.

To assess change over time across groups for the primary outcome, we employed generalized estimating equations. An intention-to-treat generalized estimated equation model, for up to 6 months of follow-up, found no differences in rates of depressive symptoms among intervention versus control (OR of 0.97; 95 % CI 0.59–1.61). The time effect and interaction

Assessed for eligibility N=4,448

Excluded (did not meet eligibility criteria: infant birth weight, Apgar score, maternal age, race,

language, lack of telephone) n=1,820

Eligible to be approached for study n=2,628

Nonparticipants: n=1,894 Could not be approached (e.g. delivered on

a weekend, or weekly enrollment target already met): 1,782

Were approached in hospital but discharged before review of consent: 112

Refused: 194

Randomized n=540

Assigned to Enhanced usual care: n=270 Routine postpartum care: 270 2-week call: 252; 93.3%

Assigned to Behavioral educational intervention: n=270 Step 1: Educational session: 270 In-hospital session: 262; 97.0% Session by phone: 8; 3.0%

Step 2: 2-week telephone needs assessment: 241; 89.3%

Interview at 3 weeks completed n=251; 93.0%

Interview at 3 weeks completed n=249; 92.2%

Interview at 3 months completed n=232; 85.9%

Interview at 3 months completed n=235; 87.0%

Interview at 6 months completed n=238; 88.2%

Interview at 6 months completed n=229; 84.8%

Fig. 1 Participants' flow through study

60 E.A. Howell et al.

were not significant. Post hoc subgroup analyses examined whether the intervention was more effective among the sub- group of mothers with a high school education or less. There was no difference in positive depression screens among mothers in the intervention arm versus those in the control arm in this subgroup analysis.

Discussion

Our behavioral educational intervention aimed at addressing modifiable factors associated with postpartum depressive symptoms did not and essentially could not reduce depressive symptoms among 540 postpartum mothers as rates of depres- sive symptoms were low at baseline and subsequent time points among this population of highly educated mostly white women. Our results contrast with the results of our trial recruiting black and Latina mothers (which used the same recruitment strategy and methodologies), in which the odds of a positive depression screen were reduced by 33% for up to 6 months of follow-up for mothers randomized to the inter- vention arm as compared with the control arm (Howell et al. 2012).

The results of both of our trials suggest that this intervention may be successful in reducing racial/ethnic disparities in rates of depressive symptoms postpartum. In the trial with black and Latina mothers, the behavioral education intervention success- fully lowered the risk of a positive depression screen to roughly the same frequency as the overall rates for white and Asian mothers in the current trial. Rates of depressive symptoms in the intervention group of black and Latina mothers compared with combined rates in the current trial were similar: at 3 weeks, 8.8 versus 5.8 %, respectively, p =0.43; at 3 months, 8.4 versus 5.8 %, respectively, p =0.44; and at 6 months, 8.9 versus 4.0%, respectively, p =0.53. By targeting modifiable factors, the in- tervention helped black and Latina mothers buffer symptoms of depression.

An expanding body of research has documented the asso- ciation between potentially modifiable factors and postpartum depressive symptoms. For example, postpartum depressive symptoms are associated with physical symptoms (vaginal bleeding, breast pain, etc.), physical functioning, infant colic, and low levels of social support (Howell et al. 2005, 2006, 2009). Our intervention aimed to prepare and educate mothers about the postpartum experience, to normalize symptoms and other experiences, to provide specific, concrete suggestions for coping with realistic time frames for observing benefits, to bolster personal and social resources, and to better manage postpartum demands. We hypothesize that the intervention likely worked among low-income black and Latina women because the prevalence of their depressive symptoms was

Table 1 Demographic and clinical characteristics of trial participants

Behavioral educational intervention (N=270)

Enhanced usual care (N=270)

p value

Demographic characteristics

Age, mean (SD), years 33 (6) 32 (5) 0.12

Race, no. (%)

Non-Hispanic white or Caucasian 233 (86) 246 (91) 0.17

Asian 30 (11) 21 (8)

Other 7 (3) 3 (1)

Birthplace, no. (%) 0.27

US born 199 (74) 210 (78)

Foreign born 71 (26) 60 (22)

Language, no. (%)

English 270 (100) 270 (100)

Education, no. (%) 0.23

High school or less 34 (13) 44 (16)

Some college or more 235 (87) 226 (84)

Insurance, no. (%) 0.78

Medicaid/Medicaid-managed care 8 (3) 6 (2)

Private/other 262 (97) 263 (98)

Marital status, no. (%) 0.13

Single/separated/divorced/widowed 8 (3) 3 (1)

Married/living as if married 262 (97) 267 (99)

Parity, no. (%) 0.46

Primiparous 129 (49) 122 (46)

Multiparous 135 (51) 145 (54)

Breastfeeding, no. (%) 0.01

Yes 257 (95) 241 (89)

No 13 (5) 29 (11)

Clinical characteristics

Delivery type, no. (%) 0.02

C-section 90 (34) 65 (24)

Vaginal delivery 178 (66) 203 (76)

Comorbid condition, no. (%) 0.71

Yes 33 (12) 36 (13)

No 234 (88) 232 (87)

Antepartum complication, no. (%) 0.36

Yes 58 (21) 49 (22)

No 212 (79) 218 (82)

Past history of depression, no. (%) 0.25

Yes 65 (24) 54 (20)

No 205 (76) 216 (80)

Treatment for depression (medication or therapy/counseling) this pregnancy, no. (%) Yes 14 (5) 21 (8) 0.22

No 256 (95) 249 (92)

Positive baseline depression screen (EPDS≥10), no. (%)

0.37

Yes 31 (11) 38 (14)

No 239 (89) 232 (86)

An intervention to reduce postpartum depressive symptoms 61

higher at baseline, and many may have lacked the tools and support necessary to manage postpartum stressors. Providing tools and resources to low-income minority mothers, who are at highest risk of postpartum depressive symptoms, has the potential to lower the burden of depressive symptoms and place them at similar risk as higher-income majority women.

Studies do suggest that interventions selectively targeting women at elevated risk for postpartum depression may be more effective than universal interventions aimed at preventing post- partum depression (Dennis and Doswell 2013). However, there is little consistency in the identification of women “at risk,” and a review of 16 antenatal screening tools suggests that there are no measures with acceptable predictive validity to accurately identify asymptomatic women who will later develop postpar- tum depression (Austin and Lumley 2003). For this trial, we chose to include women regardless of their baseline depressive symptom score, a universal approach that is simple, because we expected much higher rates of depressive symptoms in our participants. The rates of depressive symptoms in our cohort were lower than previously published literature including those assessed in our prior longitudinal studies (Howell et al. 2005). Over the last decade, public awareness for postpartum depres- sion has risen, and numerous education campaigns on this topic may have impacted prevalence rates of depressive symptoms at our hospital and in the region. The base rates of depressive symptoms were roughly 20 % lower both in the current study and in the successful trial with black and Latina mothers. As behaviors, both symptomatic and nonsymptomatic, e.g., adher- ence, are triggered and moderated by many factors, there are multiple pathways for changing behavior outside the frame- work of a clinical trial. A number of high-profile public aware- ness campaigns and legislative initiatives aimed at educating women about postpartum depression were put into place in the period between 2002 and 2009 (Postpartum Support International 2010). It is possible that these initiatives and the longitudinal studies conducted in our setting interacted to gen- erate alternative pathways that normalized and destigmatized postpartum depression. Research on public service mental health campaigns has been found to be effective in engender- ing greater awareness, positive changes in attitudes regarding depression, attitudes toward antidepressants, and to a certain extent treatment-seeking behavior (Paykel et al. 1998).

There were a number of limitations with this trial. First, the rate of positive depressive symptom screens was much lower than previously published rates. It is possible that womenwith depressive symptoms were less likely to enroll in our random- ized controlled trial. However, our refusal rate was low. In addition, the low prevalence of depressive symptoms limited the power of this study to detect a difference in rates of depressive symptoms between the intervention and control arms in this trial. This study was powered to intervene on base rates of postpartum depressive symptoms detected in prior

longitudinal studies in this same catchment area. The results of this negative trial highlight the importance of monitoring ongoing rates of depressive symptoms, the focus of this be- havioral intervention. Second, women with positive depres- sion screens were more likely to be lost to follow-up at 3 weeks. However, the overall rate of positive depression screens was low, and only 12 women who screened positive for depression at baseline were lost to follow-up at 3 weeks. Third, we used a depression screening instrument rather than a formal structured interview to diagnose depression. Our inter- vention was implemented in an obstetrics settingwhere formal assessments are often too burdensome to perform. Further, positive screens for depression, whether or not they are asso- ciated with diagnosis of major depressive disorder, are an important measure to assess as they are associated with mul- tiple negative outcomes for mothers and infants (Zayas et al. 2002; Beeghly et al. 2003; Dennis and Ross 2005; McLearn et al. 2006). And finally, this trial was implemented at one institution, and the majority of the patients were educated and white which limits the generalizability of our results.

We found that a behavioral education intervention did not reduce postpartum depressive symptoms among a sample of highly educated and predominantly white mothers because their prevalence of depressive symp- toms was low. In contrast, the intervention was success- ful in reducing depressive symptoms among postpartum black and Latina mothers. Postpartum depressive symptoms affect women from all racial/ethnic and socioeconomic back- grounds but are more burdensome for low-income women of color who often have fewer resources available to them and less access to treatment. This simple, low-cost intervention appears to be of benefit for low-income women of color and may help address early modifiable factors associated with depressive symptoms. It remains to be demonstrated whether the intervention will prove equally beneficial for a sample of white, non-Latino women reporting higher rates of depressive symptoms.

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