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

Sander Veldhuyzen van Zanten⁶  Marie Lane-Smith⁶  Wendy Sword⁴  Glenda MacQueen³  Gerri Lasiuk⁶  Arto Ohinmaa⁶  Rebecca Giallo¹  Sarah McDonald⁴  Kathy Hegadoren⁶  Marie-Paule Austin⁵  Anne Biringer²  Sheila McDonald³  Dawn Kingston⁶ 

[1] Parenting Research Centre, East Melbourne, VIC 3002, Australia;University of Toronto, Toronto, ON, Canada;University of Calgary, Calgary, AB T2N 1 N4, Canada;McMaster University, Hamilton, ON L8S 4 L8, Canada;University of New South Wales (AU), Kensington NSW 2052, Australia;University of Alberta, 11405-87th Avenue, Edmonton, T6G 1C9, Canada

关键词: Randomized controlled trial;    Stress;    Anxiety;    Depression;    Pregnancy;    Screening;    Online;    Psychosocial assessment;   

Others  :  807726
DOI  :  10.1186/1745-6215-15-3

 received in 2013-09-18, accepted in 2013-12-11,  发布年份 2014

【 摘 要 】

Background

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.

Methods/Design

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.

Trial registration

ClinicalTrials.gov Identifier: NCT01899534.

【 授权许可】

   
2014 Kingston et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Andersson L, Sundstrom-Poromaa I, Wulff M, Astrom M, Bixo M: Depression and anxiety during pregnancy and six months postpartum: a follow-up study. Acta Obstet Gynecol Scand 2006, 85:937-944.
• [2]Kingston D, Heaman M, Fell D, Dzakpasu S, Chalmers B: Factors associated with perceived stress and stressful life events in pregnant women: findings from the Canadian Maternity Experiences Survey. Matern Child Health J 2012, 16:158-168.
• [3]Priest SR, Austin MP, Barnett BB, Buist A: A psychosocial risk assessment model (PRAM) for use with pregnant and postpartum women in primary care settings. Arch Womens Ment Health 2008, 11:307-317.
• [4]Grant KA, McMahon C, Austin MP: Maternal anxiety during the transition to parenthood: a prospective study. J Affect Disord 2008, 108:101-111.
• [5]Horwitz SM, Briggs-Gowan MJ, Storfer-Isser A, Carter AS: Persistence of maternal depressive symptoms throughout the early tears of childhood. J Womens Health (Larchmt) 2009, 18:637-645.
• [6]Mayberry LJ, Horowitz JA, Declercq E: Depression symptom prevalence and demographic risk factors among U.S. women during the first 2 years postpartum. J Obstet Gynecol Neonatal Nurs 2007, 36:542-549.
• [7]Hobel CJ, Goldstein A, Barrett ES: Psychosocial stress and pregnancy outcome. Clin Obstet Gynecol 2008, 51:333-348.
• [8]Kingston D: The effects of prenatal and postpartum maternal psychological distress on child development: a systematic review. Edmonton, Alberta: The Centre for Child, Family and Community Research; 2011.
• [9]Kingston D, Tough S, Whitfield H: Prenatal and postpartum maternal psychological distress and infant development: a systematic review. Child Psychiatry Hum Dev 2012, 43:683-714.
• [10]Austin MP, Kildea S, Sullivan E: Maternal mortality and psychiatric morbidity in the perinatal period: challenges and opportunities for prevention in the Australian setting. Med J Aust 2007, 186:364-367.
• [11]Coates AO, Schaefer CA, Alexander JL: Detection of postpartum depression and anxiety in a large health plan. J Behav Health Serv Res 2004, 31:117-133.
• [12]Spitzer RL, Williams JB, Kroenke K, Hornyak R, McMurray J: Validity and utility of the PRIME-MD patient health questionnaire in assessment of 3000 obstetric-gynecologic patients: the PRIME-MD patient health questionnaire obstetrics-gynecology study. Am J Obstet Gynecol 2000, 183:759-769.
• [13]Carroll JC, Reid AJ, Biringer A, Midmer D, Glazier RH, Wilson L, Permaul JA, Pugh P, Chalmers B, Seddon F, Stewart DE: Effectiveness of the Antenatal Psychosocial Health Assessment (ALPHA) form in detecting psychosocial concerns: a randomized controlled trial. CMAJ 2005, 173:253-259.
• [14]Mitchell AJ, Coyne J: Screening for postnatal depression: barriers to success. BJOG 2009, 116:11-14.
• [15]Dennis CL, Chung-Lee L: Postpartum depression help-seeking barriers and maternal treatment preferences: a qualitative systematic review. Birth 2006, 33:323-331.
• [16]Woolhouse H, Brown S, Krastev A, Perlen S, Gunn J: Seeking help for anxiety and depression after childbirth: results of the maternal health study. Arch Womens Ment Health 2009, 12:75-83.
• [17]Sword W, Busser D, Ganann R, McMillan T, Swinton M: Women's care-seeking experiences after referral for postpartum depression. Qual Health Res 2008, 18:1161-1173.
• [18]Flynn HA, Henshaw E, O’Mahen H, Forman J: Patient perspectives on improving the depression referral processes in obstetrics settings: a qualitative study. Gen Hosp Psychiatry 2010, 32:9-16.
• [19]Reay R, Matthey S, Ellwood D, Scott M: Long-term outcomes of participants in a perinatal depression early detection program. J Affect Disord 2011, 129:94-103.
• [20]Chew-Graham CA, Sharp D, Chamberlain E, Folkes L, Turner KM: Disclosure of symptoms of postnatal depression, the perspectives of health professionals and women: a qualitative study. BMC Fam Pract 2009, 10:7. BioMed Central Full Text
• [21]Miller L, Shade M, Vasireddy V: Beyond screening: assessment of perinatal depression in a perinatal care setting. Arch Womens Ment Health 2009, 12:329-334.
• [22]Austin M-P, Highet N, Committee atGEA: Clinical practice guidelines for depression and related disorders - anxiety, bipolar disorder and puerperal psychosis - in the perinatal period. A guideline for primary care health professionals. Melbourne: beyondblue: The National Depression Initiative; 2011.
• [23]Pignone MP, Gaynes BN, Rushton JL, Burchell CM, Orleans CT, Mulrow CD, Lohr KN: Screening for depression in adults: a summary of the evidence for the U.S. preventive services task force. Ann Intern Med 2002, 136:765-776.
• [24]Austin MP, Colton J, Priest S, Reilly N, Hadzi-Pavlovic D: The Antenatal Risk Questionnaire (ANRQ): acceptability and use for psychosocial risk assessment in the maternity setting. Women Birth 2013, 26:17-25.
• [25]Buist A, Condon J, Brooks J, Speelman C, Milgrom J, Hayes B, Ellwood D, Barnett B, Kowalenko N, Matthey S, Austin MP, Bliszta J: Acceptability of routine screening for perinatal depression. J Affect Disord 2006, 93:233-237.
• [26]Matthey S, White T, Phillips J, Taouk R, Chee TT, Barnett B: Acceptability of routine antenatal psychosocial assessments to women from English and non-English speaking backgrounds. Arch Womens Ment Health 2005, 8:171-180.
• [27]Buist A, Ellwood D, Brooks J, Milgrom J, Hayes BA, Sved-Williams A, Barnett B, Karatas J, Bilszta J: National program for depression associated with childbirth: the Australian experience. Best Pract Res Clin Obstet Gynaecol 2007, 21:193-206.
• [28]Chew-Graham C, Chamberlain E, Turner K, Folkes L, Caulfield L, Sharp D: GPs’ and health visitors’ views on the diagnosis and management of postnatal depression: a qualitative study. Br J Gen Pract 2008, 58:169-176.
• [29]Leiferman JA, Dauber SE, Paulson JF, Heisler K: Primary care physicians’ beliefs and practices toward maternal depression. J Womens Health (Larchmt) 2008, 17:1143-1150.
• [30]Reid AJ, Biringer A, Carroll JD, Midmer D, Wilson LM, Chalmers B, Stewart DE: Using the ALPHA form in practice to assess antenatal psychosocial health. Antenatal psychosocial health assessment. CMAJ 1998, 159:677-684.
• [31]Coleman VH, Carter MM, Morgan MA, Schulkin J: Obstetrician-gynecologists’ screening patterns for anxiety during pregnancy. Depress Anxiety 2008, 25:114-123.
• [32]Bowen A, Bowen R, Butt P, Rahman K, Muhajarine N: Patterns of depression and treatment in pregnant and postpartum women. Can J Psychiatry 2012, 57:161-167.
• [33]Kim JJ, La Porte LM, Adams MG, Gordon TE, Kuendig JM, Silver RK: Obstetric care provider engagement in a perinatal depression screening program. Arch Womens Ment Health 2009, 12:167-172.
• [34]Leddy M, Haaga D, Gray J, Schulkin J: Postpartum mental health screening and diagnosis by obstetrician-gynecologists. J Psychosom Obstet Gynaecol 2011, 32:27-34.
• [35]Swalm D, Brooks J, Doherty D, Nathan E, Jacques A: Using the Edinburgh postnatal depression scale to screen for perinatal anxiety. Arch Womens Ment Health 2010, 13:515-522.
• [36]Choo EK, Ranney ML, Aggarwal N, Boudreaux ED: A systematic review of emergency department technology-based behavioral health interventions. Acad Emerg Med 2012, 19:318-328.
• [37]Renker PR: Breaking the barriers: the promise of computer-assisted screening for intimate partner violence. J Midwifery Womens Health 2008, 53:496-503.
• [38]MacMillan HL, Wathen CN, Jamieson E, Boyle M, McNutt LA, Worster A, Lent B, Webb M: Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA 2006, 296:530-536.
• [39]Renker PR, Tonkin P: Women’s views of prenatal violence screening: acceptability and confidentiality issues. Obstet Gynecol 2006, 107:348-354.
• [40]Renker PR, Tonkin P: Postpartum women’s evaluations of an audio/video computer-assisted perinatal violence screen. Comput Inform Nurs 2007, 25:139-147.
• [41]Le HN, Perry DF, Sheng X: Using the internet to screen for postpartum depression. Matern Child Health J 2009, 13:213-221.
• [42]Locke SE, Kowaloff HB, Hoff RG, Safran C, Popovsky MA, Cotton DJ, Finkelstein DM, Page PL, Slack WV: Computer interview for screening blood donors for risk of HIV transmission. MD Comput 1994, 11:26-32.
• [43]Turner CF, Ku L, Rogers SM, Lindberg LD, Pleck JH, Sonenstein FL: Adolescent sexual behavior, drug use, and violence: increased reporting with computer survey technology. Science 1998, 280:867-873.
• [44]Buchanan T: Internet-based questionnaire assessment: appropriate use in clinical contexts. Cogn Behav Ther 2003, 32:100-109.
• [45]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Group C: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309.
• [46]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Group C: Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med 2008, 148:W60-W66.
• [47]Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB: Designing clinical research. 3rd edition. Philadelphia, PA: Lippincott Williams & Wilkins; 2007.
• [48]Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D: SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013, 158:200-207.
• [49]Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D: SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013, 346:e7586.
• [50]Midmer D, Carroll J, Bryanton J, Stewart D: From research to application: the development of an antenatal psychosocial health assessment tool. Can J Public Health 2002, 93:291-296.
• [51]Blackmore ER, Carroll J, Reid A, Biringer A, Glazier RH, Midmer D, Permaul JA, Stewart DE: The use of the Antenatal Psychosocial Health Assessment (ALPHA) tool in the detection of psychosocial risk factors for postpartum depression: a randomized controlled trial. J Obstet Gynaecol Can 2006, 28:873-878.
• [52]Cox JL, Holden JM, Sagovsky R: Detection of postnatal depression. Development of the 10-item Edinburgh postnatal depression scale. Br J Psychiatry 1987, 150:782-786.
• [53]Matthey S: Using the Edinburgh postnatal depression scale to screen for anxiety disorders. Depress Anxiety 2008, 25:926-931.
• [54]Gemmill AW, Leigh B, Ericksen J, Milgrom J: A survey of the clinical acceptability of screening for postnatal depression in depressed and non-depressed women. BMC Public Health 2006, 6:211. BioMed Central Full Text
• [55]Vogel DL, Wester SR: To seek help or not to seek help: the risks of self-disclosure. J Couns Psychol 2003, 50:351-361.
• [56]Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH: A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol 2010, 10:1. BioMed Central Full Text
• [57]Milgrom J, Negri LM, Gemmill AW, McNeil M, Martin PR: A randomized controlled trial of psychological interventions for postnatal depression. Br J Clin Psychol 2005, 44:529-542.
• [58]Sword W, Watt S, Krueger P, Thabane L, Landy CK, Farine D, Swinton M: The Ontario Mother and Infant Study (TOMIS) III: a multi-site cohort study of the impact of delivery method on health, service use, and costs of care in the first postpartum year. BMC Pregnancy Childbirth 2009, 9:16. BioMed Central Full Text
• [59]Cohen J: Statistical power analysis for the behavioural sciences. New York: Academic; 1969.
• [60]McDonald S, Wall J, Forbes K, Kingston D, Kehler H, Vekved M, Tough S: Development of a prenatal psychosocial screening tool for post-partum depression and anxiety. Paediatr Perinat Epidemiol 2012, 26:316-327.
• [61]Sandelowski M: Whatever happened to qualitative description? Res Nurs Health 2000, 23:334-340.
• [62]Manning P: Narrative, content, and semiotic analysis. In Handbook of qualitative research. Edited by Denzin NL. London: Sage; 1994.