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Mental Health E-screening in Pregnant and Postpartum Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Alberta
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dawn Kingston, University of Alberta
ClinicalTrials.gov Identifier:
NCT01899534
First received: July 10, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention
Depression
Anxiety
Other: E-screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Mental Health E-screening in Pregnant and Postpartum Women

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening). [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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:
  • Proportion of pregnant and postpartum women with clinical depression and anxiety. [ Time Frame: on recruitment ] [ Designated as safety issue: No ]

    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


  • Depression and anxiety [ Time Frame: Within one week of recruitment ] [ Designated as safety issue: No ]

    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


  • Cost-effectiveness of e-screening [ Time Frame: during recruitment ] [ Designated as safety issue: No ]
    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:
  • Mean scores on the Perceived Risk and Perceived Utility subscales of DES [ Time Frame: on recruitment ] [ Designated as safety issue: No ]
    Disclosure Expectations Scale (DES) Self-reported by women


Estimated Enrollment: 522
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899534

Contacts
Contact: Dawn A Kingston, Ph.D 780-492-4731 dawn.kingston@ualberta.ca
Contact: Marie B Lane-Smith, M.A. 519-442-5025 mlanesmi@ualberta.ca

Locations
Canada, Alberta
Dickensfield Primary Care Maternity Clinic Recruiting
Edmonton, Alberta, Canada, T5E 6A3
Contact: Doreen Desmond    780-418-7325    Doreen.Desmond@albertahealthservices.ca   
Principal Investigator: Dawn A Kingston, Ph.D         
Royal Alexandra Hospital: Lois Hole Hospital for Women Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Selikke Janes-Kelley, RN    780-7354111    Ronna.Antoniuk@albertahealthservices.ca   
Principal Investigator: Dawn A Kingston, Ph.D         
Sturgeon Primary Care Maternity Clinic Recruiting
St. Albert, Alberta, Canada, T8N 6C4
Contact: Doreen Desmond    780-418-7325    Doreen.Desmond@albertahealthservices.ca   
Principal Investigator: Dawn A Kingston, Ph.D         
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Dawn A Kingston, Ph.D University of Alberta
  More Information

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dawn Kingston, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01899534     History of Changes
Other Study ID Numbers: 00039130
Study First Received: July 10, 2013
Last Updated: May 20, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Pregnancy
Mental Health
Screening
Computer
Feasibility

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 20, 2014