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OpenTrials
Completed

NCT Number: NCT01899534

Mental Health E-screening in Pregnant and Postpartum Women

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dickensfield Primary Care Maternity Clinic, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

    self-reported

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2013
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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