Mental Health E-screening in Pregnant and Postpartum Women
To compare e-screening versus usual screening on: 1) women's and healthcare providers' views on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5) psychometric properties. We also aim to identify factors associated with feasibility of e-screening.Compared to usual screening:1) e-screening is as feasible; 2) e-screening yields similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk of disclosure is significantly lower and benefit of disclosure is significantly higher in the e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and postpartum depression and anxiety; 5) features of e-screening are significantly associated with feasibility and acceptability, whereas demographic factors are not; and 6) reliability and validity indices of ALPHA and EPDS are strongly correlated for both administration modes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
|Official Title:||Mental Health E-screening in Pregnant and Postpartum Women|
- The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening). [ Time Frame: 10 months ] [ Designated as safety issue: No ]All women will complete: 1) the Computer Violence Assessment Evaluation (CVAE) 38 (originally designed The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening).to evaluate the feasibility/acceptability aspects of e- screening of domestic violence -Appendix C); and 2) open-ended investigator-developed questions on e-screening feasibility currently being pre-tested in another study (Appendix D).
- Proportion of pregnant and postpartum women with clinical depression and anxiety. [ Time Frame: on recruitment ] [ Designated as safety issue: No ]
Measured in in pregnant women using the Antenatal Psychosocial Health Assessment (ALPHA)and the Edinburgh Postnatal Depression Scale. Measured in pregnant women using the Edinburgh Postnatal Depression Scale.
- Depression and anxiety [ Time Frame: Within one week of recruitment ] [ Designated as safety issue: No ]
Mini Diagnostic Interview
-will be conducted either by telephone or in-person by a member of the research team who is a mental health expert
- Cost-effectiveness of e-screening [ Time Frame: during recruitment ] [ Designated as safety issue: No ]We will observe the clinic process for a morning to determine the length of time it takes staff to conduct the both the usual screening process as well as the e-screening process (e.g., distribute tablets, follow-up with women). We will also interview the clinic manager to determine the costs of current screening process (e.g., time to screen, physical resources).
- Mean scores on the Perceived Risk and Perceived Utility subscales of DES [ Time Frame: on recruitment ] [ Designated as safety issue: No ]Disclosure Expectations Scale (DES) Self-reported by women
|Study Start Date:||July 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: Paper-based screening
Paper-based screening. Women will complete a mental health screening tool on paper (usual care).
Women will complete mental health screening on a tablet
E-screening will be conducted on a computer tablet with wireless access. The tablet will be configured with the screening tool currently used in each clinic. The content and order of individual questions will be identical to the paper-pen version. Response options will be listed in full view under each question. Women select responses by touching the screen.
Given that it is critical to conduct screening within a system that links referral and treatment, our IMPACT pilot trial is evaluating integrated screening and care (see Summary of Progress) versus usual prenatal care. The proposed trial engages 2 unique clinics with experienced staff who conduct routine screening (with referrals and treatment in place) to evaluate different modalities of screening. Since widespread screening is unlikely to be successfully implemented if it entails additional human resources, this trial assesses the potential for a sustainable, e-health alternative.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01899534
|Dickensfield Primary Care Maternity Clinic|
|Edmonton, Alberta, Canada, T5E 6A3|
|Royal Alexandra Hospital: Lois Hole Hospital for Women|
|Edmonton, Alberta, Canada, T5H 3V9|
|Sturgeon Primary Care Maternity Clinic|
|St. Albert, Alberta, Canada, T8N 6C4|
|Principal Investigator:||Dawn A Kingston, Ph.D||University of Alberta|