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 Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Other: E-screening

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 566
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5E 6A3
      • Dickensfield Primary Care Maternity Clinic
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital: Lois Hole Hospital for Women
    • St. Albert, Alberta, Canada, T8N 6C4
      • Sturgeon Primary Care Maternity Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant and postpartum women will be eligible for this study if they:

  1. receive care at the recruitment sites ;
  2. can read/write English; and
  3. are willing to complete e-screening

Exclusion Criteria:

1. do not receive care at the recruitment site;
2. cannot read/write English;
3. are not willing to complete e-screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Paper-based screening; Paper-based screening. Women will complete a mental health screening tool on paper (usual care).
Experimental: E-screening; Women will complete mental health screening on a tablet	Other: E-screening; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening).	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).	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of pregnant and postpartum women with clinical depression and anxiety.	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. self-reported	on recruitment
Depression and anxiety	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	Within one week of recruitment
Cost-effectiveness of e-screening	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).	during recruitment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean scores on the Perceived Risk and Perceived Utility subscales of DES	Disclosure Expectations Scale (DES) Self-reported by women	on recruitment

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Dawn A Kingston, Ph.D, University of Alberta

Publications and helpful links

General Publications

• Kingston D, Biringer A, Veldhuyzen van Zanten S, Giallo R, McDonald S, MacQueen G, Vermeyden L, Austin MP. Pregnant Women's Perceptions of the Risks and Benefits of Disclosure During Web-Based Mental Health E-Screening Versus Paper-Based Screening: Randomized Controlled Trial. JMIR Ment Health. 2017 Oct 20;4(4):e42. doi: 10.2196/mental.6888.
• Kingston D, Austin MP, Veldhuyzen van Zanten S, Harvalik P, Giallo R, McDonald SD, MacQueen G, Vermeyden L, Lasiuk G, Sword W, Biringer A. Pregnant Women's Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 7;19(4):e88. doi: 10.2196/jmir.6866.
• Kingston D, McDonald S, Biringer A, Austin MP, Hegadoren K, McDonald S, Giallo R, Ohinmaa A, Lasiuk G, MacQueen G, Sword W, Lane-Smith M, van Zanten SV. Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial. Trials. 2014 Jan 2;15:3. doi: 10.1186/1745-6215-15-3.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Mental Health; Feasibility; Pregnancy; Screening; Computer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 00039130