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At prevalence rates of up to 40%, rates of depression and anxiety among women with medically complex pregnancies are 3 times greater than those in community-based samples of pregnant women. However, mental health care is not a component of routine hospital-based antenatal care for medically high-risk pregnant women.
The purpose of this study is to evaluate the effectiveness and feasibility of the hospital-based implementation of a Web-based integrated mental health intervention comprising psychosocial assessment, referral, and cognitive behavioral therapy (CBT) for antenatal inpatients.
This study is a quasi-experimental design. 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) >16 years of age, and (6) not actively suicidal. Women admitted to the unit for induction (eg, <72-hour length of stay) are excluded. A minimum sample of 54 women will be recruited from the antenatal high-risk unit of a large, urban tertiary care hospital. All women will complete a Web-based psychosocial assessment and 6 Web-based CBT modules. Results of the psychosocial assessment will be used by a Web-based clinical decision support system to generate a clinical risk score and clinician prompts to provide recommendations for the best treatment and referral options. The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6-8 weeks postrecruitment. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence at 3-months postpartum; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. All women will complete email questionnaires at 6-8 weeks postrecruitment and 3-months postpartum. Qualitative interviews with 10-15 health care providers and 15-30 women will provide data on feasibility and acceptability of the intervention.
The study was funded in September, 2014 and ethics was approved in November, 2014. Subject recruitment will begin January, 2015 and results are expected in December, 2015. Results of this study will determine (1) the effectiveness of an integrated Web-based prenatal mental health intervention on maternal and infant outcomes and (2) the feasibility of implementation of the intervention on a high-risk antenatal unit.
This study will provide evidence and guidance regarding the implementation of a Web-based mental health program into routine hospital-based care for women with medically high-risk pregnancies.
Depression, anxiety, and stress are among the most common morbidities in pregnancy [
Few studies have explored mental health rates and needs in women hospitalized with high-risk pregnancies. Available research suggests that these women represent a vulnerable group with rates of anxiety and depression up to 40%—more than 3 times greater than those reported in community-based samples of pregnant women [
Barriers to the delivery of prenatal mental health care are ubiquitous across community- and hospital-based settings. In the absence of routine, standardized screening as a component of prenatal care, prenatal mental illness is underdetected and undertreated. Less than one-third of women with depression and anxiety are detected by obstetrical providers [
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 [
Web-based psychosocial assessment can address barriers related to limited time; thus, it is a feasible option for high-paced clinical settings. It offers a standardized approach to assessment, can be adapted for use in populations with low literacy through the addition of audio or video components, can be linked with electronic medical record systems [
Web-based clinical decision support systems promote evidence-based, personalized care by generating ideal treatment and referral options based on a patient’s risk profile [
Group-based cognitive behavioral therapy (CBT) is an effective intervention for reducing postpartum depression [
This study is an extension of an in-progress community-based randomized controlled trial (RCT), the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT) [
What is the effectiveness of the integrated mental health intervention on (1) the prevalence and severity of prenatal depression, anxiety, and stress in antenatal inpatients and (2) the prevalence and severity of postnatal depression, anxiety, and stress at 3-months postpartum compared to preintervention?
What is the acceptability and feasibility of the intervention for women?
What is the logistical and economic feasibility of implementing the integrated mental health intervention as a component of routine hospital-based antenatal care? What is needed to improve the clinical utility of the intervention in the hospital setting?
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) [
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 [
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) [
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 [
Women access the 6-module Web-based CBT program through a password-protected link. Two [
Screenshot of the introduction to the Web-based CBT module.
Screenshot of a sample exercise.
The proposed study is a before-after quasi-experimental design with a qualitative component. Because women in the antenatal unit interact frequently, it was not possible to avoid the contamination that would occur in a RCT. The study has 2 phases: (1) phase 1—the before-after study designed to evaluate the clinical- and cost-effectiveness of the integrated psychosocial assessment-referral-CBT intervention and (2) phase 2—a qualitative descriptive component designed to assess the utility, usability, feasibility, and acceptability of the intervention.
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):
In the past week, have you sometimes felt hopeless about the future?
In the past week, have you sometimes wished you were dead?
In the past week, have you sometimes thought of ending your life?
If yes, is there anything that would stop you from acting on these thoughts of ending your life?
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) [
The primary outcome is the presence and severity of prenatal depression, anxiety, and stress symptoms at 6-8 weeks post-recruitment as measured
by the DASS21 [
The presence of symptoms of prenatal depression, anxiety, and stress is measured as the proportion of women scoring above established DASS21 cut-offs (>10, >8, and >15, respectively) [
The secondary clinical outcomes are presence and severity of symptoms of postpartum depression, anxiety, and stress [
Measures (primary and secondary clinical outcomes; other) and timeline for phase 1 of the quasi-experimental study.
Measures | Timeline of assessments | |||
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Baseline | 6-8 weeks | 3-months postpartum | |
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Prenatal depression, anxiety, stress symptoms (Depression Anxiety Stress Scale, DASS21) presence (% above cut-off point) and severity (mean score, SD) | X | X |
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Psychosocial assessment (Antenatal Risk Questionnaire-Revised, ANRQ-R; includes substance use and violence) | X |
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Depression (Edinburgh Postnatal Depression Scale, EPDS) | X | X | X |
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Postnatal depression, anxiety, stress symptoms (Depression Anxiety Stress Scale, DASS21) presence (% above cut-off point) and severity (mean score, SD) |
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X |
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Social support (Interpersonal Support Evaluation List, ISEL) | X | X | X |
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ANRQ-R acceptability | X |
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Mastery (Pearlin’s Mastery Scale) | X | X | X |
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Self-efficacy (Generalized Self-Efficacy Scale) | X | X | X |
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Self-esteem [ |
X | X | X |
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Resilience (Connor-Davidson Resilience Scale) | X | X | X |
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Sleep (Pittsburgh Sleep Quality Index) | X | X | X |
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Parenting competence (Parenting Sense of Competence Scale, PSCS; subscales Efficacy, Interest, Satisfaction) |
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X |
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Parenting stress (Parental Stress Scale) |
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X |
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Relationship quality and adjustment (Dyadic Adjustment Scale, DAS-7) | X | X | X |
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Coping (Brief Cope) | X | X | X |
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Maternal-infant attachment [ |
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X |
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Infant behavior (Infant Behavior Questionnaire) |
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X |
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Infant development (Ages and Stages Questionnaire, 3rd edition, ASQ-3; The Baby Pediatric Symptom Checklist for Social/Emotional Screening) |
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X |
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Birthweight (medical record) |
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X |
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Gestational age (medical record) |
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X |
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5-minute Apgar score (medical record) |
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X |
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Feeding method (medical record; parent report); neonatal/infant health (medical record; parent report) (Parent report from All Our Babies birth cohort studya) |
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X |
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Demographics (education, income, maternal age at recruitment, ethnicity; items from Maternity Experiences Survey, MESb) | X |
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Obstetric and medical history (parity, chronic and pregnancy complications, type of delivery, weight at prepregnancy, delivery, 6 weeks postpartum) (self-report items from MES; medical record) | X |
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X |
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Mental health history (history of depression, anxiety, stress; age of onset of previous episodes of mental health problems) (items from MES) | X |
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Pharmacologic therapy for depression/anxiety (past; current) (items from Canadian Community Health Survey, CCHS) | X | X | X |
a The All Our Babies Birth Cohort study is a pregnancy birth cohort in Alberta, Canada. Details of the study methodology and design have been previously published [
b The Maternity Experiences Survey (MES) is a national survey designed and administered by the Public Health Agency of Canada and Statistics Canada [
Secondary process outcomes related to the overall feasibility of the intervention focus on its cost-effectiveness, efficiency, utility, usability, and acceptability (
Measures of secondary process outcomes.
Secondary process outcomes | Baseline | 6-8 weeks | 3 months postpartum | ||
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Women’s health service use, medication use (self-report and medical record) | X | X | X |
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Women’s quality of life (For economic analysis-SF-12,SF-6D to calculate QALY) | X | X | X |
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Costs related to hospital-based implementation (eg, computer access; time to manage referrals) |
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X |
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Efficiency of intervention (% of women with psychosocial assessment, referral, and care; self-report and medical record) | X | X | X | |
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Utility of intervention (1 question asked at the end of each CBT exercise: “This exercise was useful to me” with 4 response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly disagree; 1 question asked at the end of each CBT module: “The information in this module was useful to me” with same response options) | X | X |
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Usability of intervention (1 question asked at the end of each CBT exercise: “This exercise was clear and easy to understand” with response options; 2 questions asked at the end of each module: “The information in this module was clear and easy to understand” and “It was easy to work through the module [for example, it was easy for me to get from 1 part to the other, easy to find what I needed]” with same response options) | X | X |
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Web-based psychosocial assessment (1 question at end of completing ANRQ-R: “I would recommend a Web-based approach to asking about emotional health to a pregnant friend” with 4 response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly disagree) | X |
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CBT (1 question at end of each CBT module: “I would recommend this module to a pregnant friend who was struggling with stress, depression, or anxiety” with 4 response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly disagree) | X | X |
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Overall assessment (2 open-ended questions at the end of every CBT module: “The thing I liked most about this module was...” and “The thing I liked least about this module was...”) | X | X |
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Efficiency (providers’ views of the efficiency of the intervention in facilitating referrals and care; women’s views on access to timely care) |
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X | |
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Utility (providers’ views on the usefulness of the intervention in promoting mental health assessment, providing guidance on referral/treatment; aiding referral process; women’s views of how useful the modules were in meeting their needs) |
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X | |
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Usability (women’s views of how easy/difficult the modules were to navigate) |
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X | |
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Feasibility (providers’ views of feasibility of the integrated intervention in their setting; women’s views of the feasibility of doing the modules; Google Analytics such as % women accessing CBT within 2 weeks postassessment; % women accessing each CBT module within 1-2 weeks; % completion of all 6 CBT modules; % completion of CBT modules within 8 weeks) |
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X | |
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Acceptability (providers’ views; women’s views) |
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X |
The 3 data collection points for all study participants are recruitment (pretest), 6-8 weeks postenrollment (posttest), and 3 months postpartum (
No data are stored on the bedside computers; when women submit their information, it is sent to a secure server housed in the Faculty of Medicine and Dentistry’s Data Centre (University of Alberta). Data transfer between the computer and server is encrypted. Follow-up questionnaires will be distributed and submitted via email that is also encrypted. All processes involving electronic data capture and storage are managed by the Women’s and Children’s Health Research Institute Informatics Core at the University of Alberta. Once recruitment has been completed, the Informatics Core will transfer data to the Health Research Data Repository at University of Alberta. The Repository is a secure, interactive environment offering storage and interactive platforms for data analysis. Electronic data will be stored for 5 years at the Data Centre and then deleted. Research team members requiring direct access to data will complete a confidentiality orientation by the Repository Manager.
Adherence to the intervention will be tracked through Google Analytics and analytics designed for this study (eg, number modules completed, length of time to complete modules, etc). As part of the qualitative descriptive component, we will seek women’s opinions about aspects of the psychosocial assessment that were challenging and features of the CBT modules that affected their ability, need, or desire to complete them. To improve adherence, the coach will send weekly text messages to women describing the importance of regular progress through the module exercises, the benefit of completing all modules, and encouragement when modules are completed. In addition, an automatic email or text message reminder will be generated if women have been inactive on the site for more than 2 weeks. The Web-based format of the intervention preserves its fidelity (ie, consistency in its components and delivery) and thus enhances external validity. To account for cointervention, follow-up questionnaires will ask women to disclose any pharmacological or nonpharmacological therapy that they have begun and this additional intervention will be accounted for in the analyses.
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 [
We will use descriptive data (frequencies and 95% CIs; means and SDs) for sample description. We will assess differences in pre- and posttest means using paired
In addition to assessing efficiency, utility, usability, and acceptability of the intervention through qualitative interviews (phase 2), we will use descriptive statistics (frequencies, proportions, means, SDs) to describe the efficiency of the intervention (eg, percentage of women with psychosocial assessment, referral, and care pretest vs posttest) and women’s perceptions of the intervention’s utility (eg, rated usefulness of exercises and information), usability (eg, ease of exercises and module), and acceptability (completion rates, willingness to recommend intervention to a friend).
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 [
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 [
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 [
We will conduct individual face-to-face or telephone-based interviews. Semistructured interview guides will be used [
We will use standard qualitative content analysis approaches for thematic analysis [
The study was funded in September, 2014 and ethics was approved in November, 2014. Subject recruitment will begin January, 2015 and results are expected in December, 2015. Results of this study will determine (1) the effectiveness of an integrated Web-based prenatal mental health intervention on maternal and infant outcomes and (2) the feasibility of implementation of the intervention on a high-risk antenatal unit.
Results of this feasibility study will guide the refinement of the 3 components of the Web-based mental health intervention and full integration in the hospital setting. In this study, the research coach plays the role of coach/case manager in that she maintains regular supportive contact with participants, reviews women’s psychosocial assessment results and debriefs them, and organizes referrals as well as linkage to the Web-based CBT program. The next steps would involve hospital-based personnel adopting this role and integration of the Web-based assessment and clinical decision support system into the electronic medical record.
Decision letter (grant review - CIHR).
cognitive behavioral therapy
21-item Depression Anxiety Stress Scale
Edinburgh Postnatal Depression Scale
Healthy Outcomes of Pregnancy and Postpartum Experiences
Maternity Experiences Survey
Quality Adjusted Life Year
randomized controlled trial
The authors would sincerely like to thank unit staff for their support. We would also like to thank Paper Leaf and AgileStyle for their partnership in developing the Web-based CBT modules. We appreciate the informatics support provided by Rick Watts and Pamela Marples of the Women’s and Children’s Health Research Institute (University of Alberta) in the construction and data management of the Web-based questionnaires. Finally, it is with great appreciation that Dr Kingston thanks this research team for its strong support.
The before-after study component is funded by the Royal Alexandra Hospital Foundation through a generous donation by Shoppers Drug Mart. The pilot trial is funded by the Norlien Foundation and the Women’s and Children’s Health Research Institute and the full trial is funded by the Canadian Institutes of Health Research (CIHR). The funders had no role in the design of the study and will not have a role in any other aspect of the trial, including its management, analysis or interpretation of data, or writing or approval of the manuscript.
None declared.