Clinical trial NCT01899534: Mental Health E-screening in Pregnant and Postpartum Women
Official title: Mental Health E-screening in Pregnant and Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Pregnancy
Mental Health
Screening
Computer
Feasibility
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-07-15
Enrollment: 566
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening).
timeFrame: 10 months
Secondary outcomes:
measure: Proportion of pregnant and postpartum women with clinical depression and anxiety.
timeFrame: on recruitment
measure: Depression and anxiety
timeFrame: Within one week of recruitment
measure: Cost-effectiveness of e-screening
timeFrame: during recruitment
Other outcomes:
measure: Mean scores on the Perceived Risk and Perceived Utility subscales of DES
timeFrame: on recruitment
Locations:
city: Edmonton
country: Canada
facility: Dickensfield Primary Care Maternity Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital: Lois Hole Hospital for Women
state: Alberta
city: St. Albert
country: Canada
facility: Sturgeon Primary Care Maternity Clinic
state: Alberta
Study officials:
affiliation: University of Alberta
name: Dawn A Kingston, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.