A growing body of evidence based on depression care in the general population suggests that 2 key strategies for reducing barriers to mental health care are (1) employing models of integrated mental health care and (2) Web-based delivery of mental health care. Both of these strategies have high utility for the perinatal period.

Mental health care is a 3-stage process involving screening, referral, and treatment. Barriers encountered at any of the 3 stages can impede women from achieving treatment success [18]. An integrated approach that seamlessly links mental health screening results to a defined referral process and treatment is a more clinically and cost-effective means for managing depression and anxiety by optimizing treatment accessibility, completion, and response [15,34-36]. Among the few studies that have evaluated the effectiveness and feasibility of models of postnatal depression care with some level of integration [37-42], integrated care results in increased screening and treatment rates with improved clinical outcomes (eg, reduction of postpartum depression). However, only 1 study to date is evaluating an integrated model of prenatal screening, referral, and treatment (trial in progress) [43].

The intervention was developed to address the need for prenatal mental health care in systems where assessment, referral, and treatment are not components of routine prenatal care. It was designed to (1) target the needs of pregnant women, recognizing that sources of anxiety and depression are unique among pregnant women; (2) overcome the most prominent barriers cited by women and health care providers regarding prenatal mental health screening and care (eg, lack of time, lack of knowledge regarding type and interpretation of screening tools, lack of linkages with mental health resources) [18,27,32,65]; and (3) provide an integrated system of assessment, referral, and treatment that would optimize the flow for providers and women from assessment to treatment. Developed by the Healthy Outcomes of Pregnancy and Postpartum Experiences (HOPE) Research Team for a pilot RCT (Integrated Maternal Psychosocial Assessment to Care Trial-Pilot; ClinicalTrials.gov identifier: NCT01901796) [43], the usability of the intervention was tested in a group of 8 pregnant women recruited from a survey-based study on views of prenatal mental health screening conducted by our team. Based on recommendations for the evaluation of health information systems [64,66,67], a research assistant met with participants individually in March 2013 and instructed them to “think aloud” as they interacted with the Web-based psychosocial assessment and CBT modules to describe their ease of use, esthetics, program capability, navigability, and content. Interviews were taped and transcribed verbatim and transcripts were reviewed by the research team to identify women’s recommendations. Minor changes were made to the CBT modules based on participants’ recommendations, primarily involving clarification of directions for exercises. Recruitment for the pilot trial will be completed by December 2014.

The integrated mental health intervention is a Web-based intervention that is available through a password-protected Web link on a bedside computer terminal. The intervention consists of 3 components: (1) psychosocial assessment, (2) a clinical decision support system that uses results of the psychosocial assessment to generate a clinical risk score with a clinician prompt that guides the provider on the best referral/treatment approaches for that woman, and (3) CBT. Given the potential enhancement of treatment outcomes in Web-based CBT supplemented by supportive coaching [41], a nontherapeutic coach is assigned to each woman. The role of the coach is to (1) discuss psychosocial assessment results, discuss referral options, and set-up referrals; (2) contact women weekly via text-based messaging to encourage completion of the CBT modules and follow-up questionnaires; and (3) address general program or technical questions.

On recruitment, women complete a single Web-based psychosocial assessment that combines a standardized screening tool (Edinburgh Postnatal Depression Scale, EPDS) to evaluate depression and anxiety symptoms in the past week with a holistic assessment of psychosocial risk factors, including mental health history, substance use, and interpersonal violence (Antenatal Risk Questionnaire, ANRQ-R) [3,28]. The ANRQ-R was designed to be embedded within an integrated system of assessment-referral-care to identify psychosocial risk factors associated with poor mental health outcomes in pregnant women. Both instruments can be completed in less than 10 minutes. The ANRQ-R has high levels of acceptability and satisfactory psychometric properties (sensitivity 0.62; specificity 0.64) [3,28], comparable to other commonly used self-report depression/anxiety tools. The EPDS is a widely used 10-item self-report depression scale used to detect depression symptoms during the previous 7 days [68]. Psychometrically validated for use in pregnant and postpartum women [69], testing revealed sound psychometric properties (sensitivity 86.7%; specificity 78%; positive predictive value 74%, α=.87) [68].

Using the EPDS and ANRQ-R scores, a Web-based decision algorithm automatically generates a clinical risk score that is linked to a clinician prompt describing the best referrals for that particular woman. Once women complete the EPDS and ANRQ, 1 of 10 clinical risk scores is calculated automatically based on the severity of symptoms and combination of risk factors (risk 1 highest to risk 10 lowest). As soon as women submit their data, they are transmitted to the Faculty of Medicine and Dentistry server. The clinical risk score and clinician prompt are then viewed by the coach who telephones each woman to discuss results of the psychosocial assessment and referral options and provides information on accessing the password-protected CBT modules. The decision support system was built for the pilot RCT [43] and has been pilot tested and refined. By way of example, for women who have mild or moderate symptoms of anxiety, stress, or depression, the Web-based CBT is the choice treatment. For women with severe symptoms, the clinical prompt would recommend Web-based CBT plus referral to a psychiatrist.

Women access the 6-module Web-based CBT program through a password-protected link. Two [70] to 6 [34] Web-based CBT sessions have been found to effectively reduce depression symptoms, and a recent feasibility study of Web-based CBT in postpartum women demonstrated completion rates of 87% in the 6-module program [34]. The topics of the modules are (1) taking stock; (2) identifying and labeling emotional health concerns; (3) changing distorted thinking; (4) understanding and changing actions, responses, and behavior; (5) relaxation; and (6) developing and maintaining a plan (Figures 1 and 2). Each module has interactive assignments that women complete. Each assignment has 1 to 4 options and women select the 1 (or more) that best suits their needs (Figure 2). Completion of the exercises is required before progression in the modules can occur. The modules use pregnancy-relevant scenarios and these are used as the basis of examples in the assignments. The Web-based delivery allows women to set their own pace by completing the modules at a time and location that is most convenient and ensures standardization of the intervention. Women access the modules using a username and password, and content that women provide in the assignments is accessible only by them.

Recruitment will take place on a 24-bed antenatal inpatient unit at a tertiary care hospital in a large, urban Canadian city (Edmonton, Alberta). The hospital has more than 6500 annual births and draws patients from the northern half of the province to serve an ethnically and sociodemographically diverse population. The average length of stay on the unit is 5.5 days and the most common admission diagnoses are preterm labor, placenta previa, and hypertension.

Pregnant women are eligible to participate if they are (1) <37 weeks gestation, (2) admitted to the antenatal inpatient unit for >72 hours, (3) able to speak and read English or be willing to use a translation service to assist with completion of the questionnaires and intervention, (4) able to complete follow-up email questionnaires, (5) aged >16 years, and 6) are not actively suicidal. Women admitted to the unit for induction (eg, <72-hour length of stay) are excluded.

Eligible women will be approached on admission by a research assistant who will describe the study and administer informed consent. Following consent, participants will complete a Web-based baseline questionnaire, which begins with the EPDS. Question 10 of the EPDS asks women about self-harm. For women who answer question 10 affirmatively, 4 additional questions pop-up to discriminate between suicidal ideation (ie, thinking about suicide with no plans) and active suicidality (ie, thinking about suicide with plans):

An affirmative response to any of these 4 questions would constitute active suicidality (=risk 1) and study exclusion. In this case, a computer message appears thanking the woman for her study participation and an email is sent to the research assistant immediately. Our safety protocol requires the research assistant to immediately inform unit nurses, who will arrange contact with hospital-based reproductive mental health services.

Women who remain eligible for the study following the EPDS completion will be permitted to continue with the baseline questionnaire for completion of the ANRQ-R and remaining baseline components. On submission, the data are securely stored in RedCap in the Faculty of Medicine and Dentistry at the University of Alberta. An automatic email informs the coach of the new participant. The coach accesses the woman’s psychosocial assessment results, the clinical risk score, and the clinician prompt in RedCap, and telephones the woman to discuss her results, referral options if applicable, and instructions for accessing the Web-based CBT. All coach contact is documented in a coach’s log in RedCap. One coach will be assigned to the recruitment site to ensure consistency across contacts.

The coach will participate in a primary investigator-led 8-hour training course that addresses the structure of each of the 3 components of the intervention, study protocols (including arranging referrals), safety protocols, interpretation of assessment tools, approaches for describing assessment results, and managing follow-up. Processes are compiled in a Coach’s Guide that is provided during training. Didactic and scenario-based practice sessions will be used during the course. Weekly meetings with the primary investigator and monthly meetings with the broader research team will be used for troubleshooting and refinement of recruitment processes.

The sample size calculation is based on the primary outcome of symptoms of depression, anxiety, and stress as measured by the depression, anxiety, and stress subscales of the 21-item Depression Anxiety Stress Scale-21 (DASS21) [71]. We calculated the sample size required to test the minimum clinically important difference in each subscale and selected the highest 1 for the final sample size. Based on DASS21 data collected as part of Australia’s national perinatal mental health initiative, standard deviations for the depression, anxiety, and stress subscales in pregnant women are 5.4, 10.2, and 8.6 [72]. To determine the minimal clinically important difference, we used Milgrom et al’s [55] approach for calculating the difference in scores on each subscale that would shift a woman 1 level of severity—the minimal, reasonable expectation for an effective therapy. For example, the DASS21 manual “categorizes” women as having normal, mild, moderate, severe, and extremely severe symptoms of depression, anxiety, and stress [71]. To shift women from midrange moderate to mild severity on the depression, anxiety, and stress subscales would require a reduction of 4 points in each subscale. Therefore, based on the sample size formula for paired t tests (2-tailed) at a significance level of 5% (1.96), a power of 80% (.84), a minimal clinically important difference of 4 points, and standard deviations of 5.4, 10.2, and 8.6 for the depression, anxiety, and stress subscales, respectively, the number of women required to detect a statistically significant difference in pre- and posttest scores would be 17 for depression symptom changes, 54 for anxiety, and 39 for stress. Therefore, based on the highest number of women needed, 54 women are required to complete full data for this study. Accounting for a participation rate of 50% based on previous studies of CBT in pregnant women [73], a conservative attrition rate of 25% based on previous studies of prenatal CBT [34,64], and a 5% loss to follow-up, 98 women would need to be invited to participate in the study to achieve the final sample size. Given the estimated number of 20 new admissions per month, the duration of recruitment is anticipated to be 5 months.

The study protocol was approved by the Human Research Ethics Board at the University of Alberta. Following electronic consent, all women receive an emailed copy of the Participant Information Letter and Consent.

Several strategies ensure women’s safety throughout the study. Mental health crisis contact information is described on a sidebar of the CBT modules, along with a statement encouraging women to contact their coach if they feel their mental health is deteriorating. The coach will contact women within 24 hours using a defined algorithm to guide decisions regarding help or referral that is recommended.

At the end of each CBT module, women will complete question 10 of the EPDS to assess self-harm thoughts over the past week. An affirmative response will generate an automatic message with crisis contact information for the woman’s immediate use and an email sent to the coach. The coach will contact the woman within 24 hours to assess whether the woman is receiving help from a health care provider. A 4% affirmative response rate to question 10 of the EPDS has been reported [14]. The coach will document all interactions in the coach’s log.

The economic evaluation will be a within-study cost-effectiveness analysis comparing the intervention with usual hospital-based mental health care. The analysis will assess costs associated with the delivery of the intervention (eg, cost of equipment, salary of coach) and subsequent service utilization by study participants. Direct health care utilization will be extracted from patient records. Data related to health and social care utilization will be collected from the medical record and self-reported by women (including SF-12). The primary outcome measure for the cost-effectiveness analysis will be the Quality Adjusted Life Year (QALY). Utilities for the construction of QALYs will be obtained from the SF-12 data using the SF-6D algorithm [95]. Because the time horizon for the analysis is less than 12 months, discounting will not be required [96]. We will report the incremental cost per QALY gained for the intervention compared to usual prenatal care. Uncertainty in the expected costs and outcomes for the integrated intervention and usual prenatal care will be characterized using the nonparametric bootstrap. The results of the bootstrap analysis will be used to construct scatterplots on the cost-effectiveness plane and cost-effectiveness acceptability curves showing the probability that the integrated intervention is a cost-effective use of health care resources for a range of values of health.

Phase 2 is a qualitative descriptive study with a primary aim of assessing women’s and health care providers’ views on efficiency, utility, usability, feasibility, and acceptability of the intervention. Phase 2 is a critical component to support further refinement of the intervention that will optimize its feasibility for women and providers, and enhance women’s engagement and adherence [58].

All women and health care providers working at the study site are eligible for participation in phase 2. Purposeful sampling will be used to maximize variability in the sample, ensuring that a broad range of views and demographics are represented [97]. We plan to interview 15-20 women and 10-15 providers (eg, unit staff, executive director, managers, reproductive mental health service staff, physicians) with the final sample size established by data saturation. Given the importance of understanding factors contributing to attrition, we will also interview women who do not complete all CBT modules. To capture these women, a statement at the end of each of the final 3 CBT modules will invite women to participate in a follow-up interview. Selection of the affirmative response will generate an automatic email to the research coordinator for follow-up. Posters and staff meetings will be used to invite unit staff members to participate in a follow-up interview.

We will conduct individual face-to-face or telephone-based interviews. Semistructured interview guides will be used [97] to ask participants their views on the efficiency, utility, usability, feasibility, and acceptability, as well as its strengths, suggestions for improvement, components that were effective/not effective, and the benefits that they experienced. The anticipated length of the interviews is 30 minutes. They will be digitally recorded and transcribed verbatim. Transcribed interviews and digital files will be stored in the Health Research Data Repository (University of Alberta) and stored for 5 years. All data will be anonymized for publication.

We will use standard qualitative content analysis approaches for thematic analysis [97]. Two members of the team experienced in qualitative analysis will independently code the first 2 or 3 transcripts and engage in discussion to reach consensus on a draft coding scheme. This coding scheme will be used to code 2 additional transcripts with revisions made as necessary. Subsequent transcripts will be coded by 1 team member. Analysis will occur concurrently with data collection to allow further exploration and clarification of emergent ideas, and data collection will continue until data saturation [98].