Mental Health E-screening in Pregnant and Postpartum Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01899534
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : October 26, 2016
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dawn Kingston, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Other: E-screening Not Applicable

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  (Clinical Trial)
Actual Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Mental Health E-screening in Pregnant and Postpartum Women
Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening). [ Time Frame: 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 :
  1. Proportion of pregnant and postpartum women with clinical depression and anxiety. [ Time Frame: 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.


  2. Depression and anxiety [ Time Frame: 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

  3. Cost-effectiveness of e-screening [ Time Frame: 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).

Other Outcome Measures:
  1. Mean scores on the Perceived Risk and Perceived Utility subscales of DES [ Time Frame: on recruitment ]
    Disclosure Expectations Scale (DES) Self-reported by women

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01899534

Canada, Alberta
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
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Dawn A Kingston, Ph.D University of Alberta

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dawn Kingston, Assistant Professor, University of Alberta Identifier: NCT01899534     History of Changes
Other Study ID Numbers: 00039130
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Dawn Kingston, University of Alberta:
Mental Health