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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.

ABSTRACT: Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed.The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (e-screening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paper-based form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening.ClinicalTrials.gov Identifier: NCT01899534.

SUBMITTER: Kingston D

PROVIDER: S-EPMC3892094 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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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.

Kingston Dawn D McDonald Sheila S Biringer Anne A Austin Marie-Paule MP Hegadoren Kathy K McDonald Sarah S Giallo Rebecca R Ohinmaa Arto A Lasiuk Gerri G MacQueen Glenda G Sword Wendy W Lane-Smith Marie M van Zanten Sander Veldhuyzen SV

Trials 20140102

<h4>Background</h4>Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and ...[more]

PMID: 24383441

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Project description:BackgroundMajor international guidelines recommend mental health screening during the perinatal period. However, substantial barriers to screening have been reported by pregnant and postpartum women and perinatal care providers. E-screening offers benefits that may address implementation challenges.ObjectiveThe primary objective of this randomized controlled trial was to evaluate the feasibility and acceptability of Web-based mental health e-screening compared with paper-based screening among pregnant women. A secondary objective was to identify factors associated with women's preferences for e-screening and disclosure of mental health concerns.MethodsPregnant women recruited from community and hospital-based antenatal clinics and hospital-based prenatal classes were computer-randomized to a fully automated Web-based e-screening intervention group or a paper-based control group. Women were eligible if they spoke or read English, were willing to be randomized to e-screening, and were willing to participate in a follow-up diagnostic interview. The intervention group completed the Antenatal Psychosocial Health Assessment and the Edinburgh Postnatal Depression Scale on a tablet computer, while controls completed them on paper. All women completed self-report baseline questions and were telephoned 1 week after randomization by a blinded research assistant for a MINI International Neuropsychiatric Interview. Renker and Tonkin's tool of feasibility and acceptability of computerized screening was used to assess the feasibility and acceptability of e-screening compared with paper-based screening. Intention-to-treat analysis was used. To identify factors associated with preference for e-screening and disclosure, variables associated with each outcome at P<.20 were simultaneously entered into final multivariable models to estimate adjusted odds ratios (AORs) and 95% CIs.ResultsOf the 675 eligible women approached, 636 agreed to participate (participation rate 94.2%) and were randomized to the intervention (n=305) or control (n=331) groups. There were no significant baseline differences between groups. More women in the e-screening group strongly or somewhat agreed that they would like to use a tablet for answering questions on emotional health (57.9%, 175/302 vs 37.2%, 121/325) and would prefer using a tablet to paper (46.0%, 139/302 vs 29.2%, 95/325), compared with women in the paper-based screening group. There were no differences between groups in women's disclosure of emotional health concerns (94.1%, 284/302 vs 90.2%, 293/325). Women in the e-screening group consistently reported the features of e-screening more favorably than controls (more private or confidential, less impersonal, less time-consuming). In the multivariable models, being in the e-screening group was significantly associated with preferring e-screening (AOR 2.29, 95% CI 1.66-3.17), while no factors were significantly associated with disclosure.ConclusionsThe findings suggest that mental health e-screening is feasible and acceptable to pregnant women.Trial registrationClinicaltrials.gov NCT01899534; https://clinicaltrials.gov/ct2/show/NCT01899534 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb).

Project description:BackgroundBlack women and their infants face heightened health risks during pregnancy, labor, and delivery that, for many, cost them their lives. Such health risks during this critical period are linked to increased rates of anxiety among Black pregnant and postpartum women. Black women also endure racism when seeking support from mental health and healthcare providers, which further contributes to pregnancy and postpartum-related anxiety. Evidence on sister circles has demonstrated that this indigenous form of healing may provide Black pregnant and postpartum women with the support and skills needed to cope with stressors associated with mental and physical health concerns and racism.ObjectiveOur study aimed to evaluate the feasibility and acceptability of the Birthing Beautiful Babies Sisters Offering Support, a sister circle cognitive behavioral therapy-based stress and anxiety intervention for Black pregnant and postpartum women.DesignOur study employed a mixed-methods framework.MethodsDescriptive analyses, paired samples t-test, and open and selective coding were conducted. We utilized the following measures: Penn State Worry Questionnaire-Abbreviated, Kessler Psychological Distress Scale, Pregnancy-Related Anxiety Scale, focus booklet, and focus group discussion.ResultsParticipants reported experiencing moderate levels of worry and distress and low levels of pregnancy-related anxiety prior to the start of the Birthing Beautiful Babies Sisters Offering Support intervention. Eighty women participated in Birthing Beautiful Babies Sisters Offering Support. Eleven focus groups were conducted to assess their experience. Participants reported a perceived increase in their knowledge about panic attacks and stress and ability to manage stressors effectively. They found that all completed activities contributed to their development and application of skills. They reported they enjoyed Birthing Beautiful Babies Sisters Offering Support because of the supportive environment, openness, and emphasis on sisterhood. Participants provided helpful feedback about the structure and flow of the intervention.ConclusionLimitations of the present study and future directions are discussed.

Project description:Mild cognitive impairment (MCI) is associated with a higher risk of dementia and is becoming a topic of interest for pharmacological and nonpharmacological interventions. With advances in technology, computer-based cognitive exercises are increasingly integrated into traditional cognitive interventions, such as cognitive training. Another type of cognitive intervention involving technology use is cognitive engagement, consisting of involving participants in highly motivational and mentally challenging activities, such as learning to use a form of new digital technology. This study examined the feasibility and acceptability of a computerized cognitive stimulation (CCS) program and a computerized cognitive engagement (CCE) program, and then compared their effects in older adults with MCI.In this randomized study, data from 19 MCI patients were analyzed (n=9 in CCS and n=10 in CCE). The patients attended a group weekly session for a duration of 3 months. Assessments of cognitive and psychosocial variables were conducted at baseline (M0) and at the end of the programs (M3).All of the participants attended the 12 sessions and showed a high level of motivation. Attrition rate was very low (one dropout at M3 assessment). At M3, the CCS participants displayed a significant improvement in part B of the Trail Making Test (TMT-B; p=0.03) and self-esteem (p=0.005), while the CCE participants showed a significant improvement in part A of the Trail Making Test (TMT-A; p=0.007) and a higher level of technology acceptance (p=0.006). The two groups did not differ significantly (p>0.05) in cognitive and psychosocial changes after the intervention. However, medium effect sizes (Cohen's d=0.56; 95% CI =-0.43:1.55) were found on the free recall, favoring the CCS group, as well as on TMT-A (d=0.51; 95% CI =-0.48:1.49) and technology acceptance (d=-0.65; 95% CI =-1.64:0.34), favoring the CCE group.Both interventions were highly feasible and acceptable and allowed improvement in different aspects of cognitive and psychosocial functioning in MCI subjects.

Project description:BackgroundGestational age (GA) is a key determinant of newborn survival and long-term impairment. Accurate estimation of GA facilitates timely provision of essential interventions to improve maternal and newborn outcomes. Menstrual based dating, ultrasound based dating, and neonatal estimates are the primarily used methods for assessing GA; all of which have some strength and weaknesses that require critical consideration. Last menstrual period (LMP) is simple, low-cost self-reported information, recommended by the World Health Organization for estimating GA but has issues of recall mainly among poorer, less educated women and women with irregular menstruation, undiagnosed abortion, and spotting during early pregnancy. Several studies have noted that about 20-50% of women cannot accurately recall the date of LMP. The goal of this study is therefore to improve recall and reporting of LMP and by doing so increase the accuracy of LMP based GA assessment in a rural population of Bangladesh where antenatal care-seeking, availability and utilization of USG is low.MethodWe propose to conduct a 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three interventions to improve recall of GA with a no intervention arm. The interventions include (i) counselling and a paper based calendar (ii) counselling and a cell phone based SMS alert system (iii) counselling and smart-phone application. The trial is being conducted among 3360 adolescent girls and recently married women in Mirzapur sub-district of Bangladesh.DiscussionEnrolment of study participants continued from January 24, 2017 to March 29, 2017. Data collection and intervention implementation is ongoing and will end by February, 2019. Data analysis will measure efficacy of interventions in improving the recall of LMP date among enrolled participants. Results will be reported following CONSORT guideline. The innovative conventional & e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where m-Health initiatives are proliferating with active support from all sectors in policy and implementation.Trial registrationClinicalTrials.gov NCT02944747 . The trial has been registered before starting enrolment on 24 October 2016.

Dataset Information

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.

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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.

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