Mental Health E-screening in Pregnant and Postpartum Women

NCT01899534 | Completed DMC

• 1 other identifier: 00039130
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression; Anxiety

Keywords

Pregnancy; Mental Health; Screening; Computer; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of pregnant and postpartum women with clinical depression and anxiety.

  on recruitment

• Depression and anxiety

  Within one week of recruitment

• Cost-effectiveness of e-screening

  during recruitment

Other Outcomes (1)

• Mean scores on the Perceived Risk and Perceived Utility subscales of DES

  on recruitment

Study Arms (2)

Paper-based screening

NO INTERVENTION

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

E-screening

EXPERIMENTAL

Women will complete mental health screening on a tablet

Other: E-screening

Interventions

E-screening 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.

E-screening

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant and postpartum women will be eligible for this study if they:
• receive care at the recruitment sites ;
• can read/write English; and
• are willing to complete e-screening

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (3)

Dickensfield Primary Care Maternity Clinic

Edmonton, Alberta, T5E 6A3, Canada

Location

Royal Alexandra Hospital: Lois Hole Hospital for Women

Edmonton, Alberta, T5H 3V9, Canada

Location

Sturgeon Primary Care Maternity Clinic

St. Albert, Alberta, T8N 6C4, Canada

Location

Related Publications (3)

• 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.

  PMID: 29054833 DERIVED

• 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.

  PMID: 28389421 DERIVED

• 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.

  PMID: 24383441 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Dawn A Kingston, Ph.D

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 15, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

CA (3)