Mental Health E-screening in Pregnant and Postpartum Women

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Other: E-screening

• Registration Number: NCT01899534
• Lead Sponsor: University of Calgary

Brief Summary

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.

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-15
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 566

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E-screening	E-screening	Women will complete mental health screening on a tablet

Primary Outcome Measures

Name	Time	Method
The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening).	10 months	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).

Secondary Outcome Measures

Name	Time	Method
Depression and anxiety	Within one week of recruitment	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
Proportion of pregnant and postpartum women with clinical depression and anxiety.	on recruitment	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
Cost-effectiveness of e-screening	during recruitment	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).

Trial Locations

Locations (3)

Dickensfield Primary Care Maternity Clinic; 🇨🇦 Edmonton, Alberta, Canada

Sturgeon Primary Care Maternity Clinic; 🇨🇦 St. Albert, Alberta, Canada

Royal Alexandra Hospital: Lois Hole Hospital for Women; 🇨🇦 Edmonton, Alberta, Canada