Mental Health E-screening in Pregnant and Postpartum Women

Depression Clinical Trial

Official title:

Mental Health E-screening in Pregnant and Postpartum Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899534
• Other study ID #: 00039130
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: October 24, 2016
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

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.

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean scores on the Perceived Risk and Perceived Utility subscales of DES	Disclosure Expectations Scale (DES) Self-reported by women	on recruitment	No
Primary	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	No
Secondary	Proportion of pregnant and postpartum women with clinical depression and anxiety.	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	on recruitment	No
Secondary	Depression and anxiety	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	Within one week of recruitment	No
Secondary	Cost-effectiveness of e-screening	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).	during recruitment	No