Internet-based Cognitive Behavioural Therapy (iCBT) for Perinatal Anxiety and Depression Versus Treatment As Usual: Study Protocol for Two Randomised Controlled Trials

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2018 Jan 24

PMID 29357918

Citations 8

Authors

Siobhan A Loughnan

Jill M Newby

Hila Haskelberg

Alison Mahoney

Natalie Kladnitski

Jessica Smith

Emma Black

Christopher Holt

Jeannette Milgrom

Marie-Paule Austin

Gavin Andrews

Affiliations

Soon will be listed here.

Abstract

Background: We aimed to evaluate the acceptability and efficacy of two brief, Internet-delivered cognitive behavioural therapy interventions-MUMentum Pregnancy (study 1) and MUMentum Postnatal (study 2)-in reducing maternal symptoms of anxiety, depression and overall psychological distress compared to usual care in the perinatal period.

Methods/design: Women who are pregnant (study 1) or < 12 months postpartum (study 2) with current clinically elevated symptoms of anxiety and/or depression according to validated self-report measures, will be recruited via the research arm of a not-for-profit clinical and research unit in Australia and randomised to the intervention group or treatment as usual control group. The minimum sample size for each study (alpha 0.05; power 0.80 for a g of 0.80) was identified as 50 with at least 10% more to be recruited to account for expected attrition. The co-primary outcome measures are the Patient Health Questionnaire 9-item scale and Generalised Anxiety Disorder 7-item scale to measure depression and anxiety symptom severity, respectively, and will be administered at the following primary time-points: baseline; post treatment; and at one-month follow-up. Psychological distress will be measured according to the Kessler-10 psychological distress scale at each primary time-point and will also be completed before each lesson for those in the intervention group. The total trial period nine weeks for study 1 and 11 weeks for study 2. Program efficacy will be determined using intent-to-treat mixed models. Maintenance of gains will be assessed at one-month follow-up.

Discussion: The current randomised controlled trial seeks to extend the literature by evaluating the efficacy of a self-help intervention for women in the perinatal period. If efficacious, the MUMentum programs have the potential to be easily disseminated via https://thiswayup.org.au/ to large numbers of women across Australia as an intervention for women screening positive for anxiety, depressive or distress symptoms during pregnancy or postpartum.

Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12616000560493 ; ACTRN12616000559415 . Registered on 2nd May 2016.

Citing Articles

Transdiagnostic internet cognitive behavioural therapy for anxiety and depressive symptoms in postnatal women: protocol of a randomized controlled trial.

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Internet-based interventions for perinatal depression and anxiety symptoms: an ethnographic qualitative study exploring the views and opinions of midwives in Switzerland.

Beerli J, Ehlert U, Amiel Castro R BMC Prim Care. 2022; 23(1):172.

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References

Cox J, Chapman G, Murray D, Jones P . Validation of the Edinburgh Postnatal Depression Scale (EPDS) in non-postnatal women. J Affect Disord. 1996; 39(3):185-9. DOI: 10.1016/0165-0327(96)00008-0. View

Kroenke K, Spitzer R, Williams J . The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001; 16(9):606-13. PMC: 1495268. DOI: 10.1046/j.1525-1497.2001.016009606.x. View

Kopelman R, Moel J, Mertens C, Stuart S, Arndt S, OHara M . Barriers to care for antenatal depression. Psychiatr Serv. 2008; 59(4):429-32. PMC: 3652590. DOI: 10.1176/ps.2008.59.4.429. View

Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W . Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008; 46(3):266-74. DOI: 10.1097/MLR.0b013e318160d093. View

crncec R, Barnett B, Matthey S . Development of an instrument to assess perceived self-efficacy in the parents of infants. Res Nurs Health. 2008; 31(5):442-53. DOI: 10.1002/nur.20271. View

Gueorguieva R, Krystal J . Move over ANOVA: progress in analyzing repeated-measures data and its reflection in papers published in the Archives of General Psychiatry. Arch Gen Psychiatry. 2004; 61(3):310-7. DOI: 10.1001/archpsyc.61.3.310. View

Webster J, Nicholas C, Velacott C, Cridland N, Fawcett L . Validation of the WHOQOL-BREF among women following childbirth. Aust N Z J Obstet Gynaecol. 2010; 50(2):132-7. DOI: 10.1111/j.1479-828X.2009.01131.x. View

Heron J, OConnor T, Evans J, Golding J, Glover V . The course of anxiety and depression through pregnancy and the postpartum in a community sample. J Affect Disord. 2004; 80(1):65-73. DOI: 10.1016/j.jad.2003.08.004. View

Sunderland M, Wong N, Hilvert-Bruce Z, Andrews G . Investigating trajectories of change in psychological distress amongst patients with depression and generalised anxiety disorder treated with internet cognitive behavioural therapy. Behav Res Ther. 2012; 50(6):374-80. DOI: 10.1016/j.brat.2012.03.005. View

10.

Austin M, Frilingos M, Lumley J, Hadzi-Pavlovic D, Roncolato W, Acland S . Brief antenatal cognitive behaviour therapy group intervention for the prevention of postnatal depression and anxiety: a randomised controlled trial. J Affect Disord. 2007; 105(1-3):35-44. DOI: 10.1016/j.jad.2007.04.001. View

11.

Grigoriadis S, de Camps Meschino D, Barrons E, Bradley L, Eady A, Fishell A . Mood and anxiety disorders in a sample of Canadian perinatal women referred for psychiatric care. Arch Womens Ment Health. 2011; 14(4):325-33. DOI: 10.1007/s00737-011-0223-5. View

12.

Andrews G, Cuijpers P, Craske M, McEvoy P, Titov N . Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010; 5(10):e13196. PMC: 2954140. DOI: 10.1371/journal.pone.0013196. View

13.

Navarro P, Ascaso C, Garcia-Esteve L, Aguado J, Torres A, Martin-Santos R . Postnatal psychiatric morbidity: a validation study of the GHQ-12 and the EPDS as screening tools. Gen Hosp Psychiatry. 2006; 29(1):1-7. DOI: 10.1016/j.genhosppsych.2006.10.004. View

14.

Skevington S, Lotfy M, OConnell K . The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004; 13(2):299-310. DOI: 10.1023/B:QURE.0000018486.91360.00. View

15.

Newby J, Mewton L, Williams A, Andrews G . Effectiveness of transdiagnostic Internet cognitive behavioural treatment for mixed anxiety and depression in primary care. J Affect Disord. 2014; 165:45-52. DOI: 10.1016/j.jad.2014.04.037. View

16.

Furukawa T, Kessler R, Slade T, Andrews G . The performance of the K6 and K10 screening scales for psychological distress in the Australian National Survey of Mental Health and Well-Being. Psychol Med. 2003; 33(2):357-62. DOI: 10.1017/s0033291702006700. View

17.

Goodman J, Tyer-Viola L . Detection, treatment, and referral of perinatal depression and anxiety by obstetrical providers. J Womens Health (Larchmt). 2010; 19(3):477-90. DOI: 10.1089/jwh.2008.1352. View

18.

OMahen H, Woodford J, McGinley J, Warren F, Richards D, Lynch T . Internet-based behavioral activation--treatment for postnatal depression (Netmums): a randomized controlled trial. J Affect Disord. 2013; 150(3):814-22. DOI: 10.1016/j.jad.2013.03.005. View

19.

van Bussel J, Spitz B, Demyttenaere K . Three self-report questionnaires of the early mother-to-infant bond: reliability and validity of the Dutch version of the MPAS, PBQ and MIBS. Arch Womens Ment Health. 2010; 13(5):373-84. DOI: 10.1007/s00737-009-0140-z. View

20.

Bergink V, Kooistra L, Lambregtse-van den Berg M, Wijnen H, Bunevicius R, van Baar A . Validation of the Edinburgh Depression Scale during pregnancy. J Psychosom Res. 2011; 70(4):385-9. DOI: 10.1016/j.jpsychores.2010.07.008. View