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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:||Loughnan, Siobhan A;Newby, Jill M;Haskelberg, Hila;Mahoney, Alison;Kladnitski, Natalie;Smith, Jessica;Black, Emma;Holt, Christopher;Milgrom, Jeannette;Austin, Marie-Paule;Andrews, Gavin|
|Affiliation:||Clinical Research Unit for Anxiety and Depression (CRUfAD), UNSW School of Psychiatry at St Vincent's Hospital, St Vincent's Hospital, Sydney, NSW, Australia|
School of Psychology, Faculty of Science, UNSW Sydney, 1302 Mathews Building, Kensington, NSW, 2052, Australia.
Perinatal & Women's Mental Health Unit, c/o St John of God Hospital, 13 Grantham Street, Burwood, NSW, 2134, Australia.
Parent-Infant Research Institute (PIRI) and Melbourne School of Psychological Science, Austin Health, Heidelberg Repatriation Hospital, Heidelberg West, Victoria, Australia
|Citation:||Trials 2018; 19(1): 56|
|Abstract:||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. 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. 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. Australian New Zealand Clinical Trials Registry, ACTRN12616000560493 ; ACTRN12616000559415 . Registered on 2nd May 2016.|
Cognitive behavioural therapy
|Appears in Collections:||Journal articles|
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