Mental Health E-screening in Pregnant and Postpartum Women

NCT ID: NCT01899534

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 566 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-12-31

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.

Conditions

Depression; Anxiety

Keywords

Pregnancy; Mental Health; Screening; Computer; Feasibility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Paper-based screening

Paper-based screening. Women will complete a mental health screening tool on paper (usual care).

Group Type: NO_INTERVENTION

No interventions assigned to this group

E-screening

Women will complete mental health screening on a tablet

Group Type: EXPERIMENTAL

E-screening

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dawn Kingston

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn A Kingston, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Dickensfield Primary Care Maternity Clinic

Edmonton, Alberta, Canada

Royal Alexandra Hospital: Lois Hole Hospital for Women

Edmonton, Alberta, Canada

Sturgeon Primary Care Maternity Clinic

St. Albert, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29054833 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28389421 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24383441 (View on PubMed)

Other Identifiers

00039130

Identifier Type: -

Identifier Source: org_study_id