Internet-based cognitive behavioural therapy (iCBT) for perinatal anxiety and depression versus treatment as usual: Study protocol for two randomised controlled trials

Siobhan Loughnan; Jill M Newby; Hila Haskelberg; Alison Mahoney; Natalie Kladnitski; Jessica Smith; Emma Black; Christopher Holt; Jeannette Milgrom; Marie-Paule Austin; Gavin Andrews

doi:10.1186/s13063-017-2422-5

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Internet-based cognitive behavioural therapy (iCBT) for perinatal anxiety and depression versus treatment as usual: Study protocol for two randomised controlled trials

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Internet-based cognitive behavioural therapy (iCBT) for perinatal anxiety and depression versus treatment as usual: Study protocol for two randomised controlled trials

Siobhan Loughnan, Jill M Newby, Hila Haskelberg, Alison Mahoney, Natalie Kladnitski, Jessica Smith, Emma Black, Christopher Holt, Jeannette Milgrom, Marie-Paule Austin, …

Trials, Vol.19, 56

2018

DOI: https://doi.org/10.1186/s13063-017-2422-5

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Abstract

perinatal

antenatal

postpartum

pregnancy

internet

online

cognitive behavioural therapy

treatment

depression

anxiety

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<12months 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 11weeks 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.

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Title: Internet-based cognitive behavioural therapy (iCBT) for perinatal anxiety and depression versus treatment as usual: Study protocol for two randomised controlled trials
Authors: Siobhan Loughnan (Author) - University of New South Wales
Jill M Newby (Author) - University of New South Wales
Hila Haskelberg (Author) - University of New South Wales
Alison Mahoney (Author) - University of New South Wales
Natalie Kladnitski (Author) - University of New South Wales
Jessica Smith (Author) - University of New South Wales
Emma Black (Author) - St John of God Hospital
Christopher Holt (Author) - Heidelberg Repatriation Hospital
Jeannette Milgrom (Author) - Heidelberg Repatriation Hospital
Marie-Paule Austin (Author) - St John of God Hospital
Gavin Andrews (Author) - University of New South Wales
Publication details: Trials, Vol.19, 56; 11
Publisher: BioMed Central Ltd.
Date published: 2018
DOI: 10.1186/s13063-017-2422-5
ISSN: 1745-6215
Copyright note: Copyright © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Organisation Unit: School of Social Sciences - Legacy; University of the Sunshine Coast, Queensland
Language: English
Record Identifier: 99450864502621
Output Type: Journal article

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