Internet-assisted cognitive behavioral intervention with telephone coaching versus an educational control for antenatal depression: protocol for a randomized controlled trial with population-based screening

Andre Sourander^1,2,3*Tarja Korpilahti-Leino^2,3Terja Ristkari^2,3Tarja Koffert^2,3Bianca Arrhenius^2,3Tiia Ståhlberg^2,3,4Susanna Hinkka-Yli-Salomäki^2,3Mari Berglund^2,3Subina Upadhyaya^2,3Wan Mohd Azam Wan Mohd Yunus^2,3,5Atte Sinokki^2,3Riku Hägg^2,3Altti Marjamäki²Iida Kankaanranta^2,3Johanna Palmroth^2,3Saana Sourander^2,3Anna Zadkova^2,3Linda Casagrande^2,3Yuko Yamada^2,3Satu Karjalainen^2,3Hanna-Maria Matinolli^2,3Miika Vuori^2,3,6

• ¹Department of Child Psychiatry, University of Turku and Turku University Hospital, Turku, Finland
• ²Research Centre for Child Psychiatry, Faculty of Medicine, University of Turku, Turku, Finland
• ³INVEST Research Flagship Centre, University of Turku, Turku, Finland
• ⁴Department of Adolescent Psychiatry, Turku University Hospital, Turku, Finland
• ⁵Faculty of Social Sciences and Humanities, Universiti Teknologi Malaysia, Johor Bahru, Malaysia
• ⁶Research Unit, The Social Insurance Institution of Finland (Kela), Helsinki, Uusimaa, Finland

Background: Up to 15% of pregnant women suffer from antenatal depression and there is mounting evidence that the consequences can be devastating for both the woman and her child. Identifying effective treatments is crucial to avoid harmful consequences of unrecognized and untreated depression. Methods: This ongoing research project evaluates the efficacy of the Stronger Together internet-assisted cognitive behavioral intervention (iCBT) with telephone coaching for antenatal depression. It is a large population-based two-parallel group randomized controlled trial. The overarching hypothesis is that iCBT programs are easy to access, affordable and will reduce self-reported symptoms of antenatal depression better than an educational control. The intervention group is also expected to report less anxiety symptoms after treatment than the control group. The protocol follows the SPIRIT guidelines. The study population consists of all Finnish or Swedish speaking women, aged ≥ 18 years, who attend maternity health check-ups at 13-18 weeks of gestation in selected areas of Finland. The aim is to recruit all women who exceed 10 points on the Edinburgh Postnatal Depression Scale and meet other eligibility criteria. Other measures used are the Beck Depression Inventory-II, the General Anxiety Disorder 7-Item Scale, the Pregnancy-Related Anxiety Questionnaire-Revised, the Social Phobia Inventory and the Perceived Stress Scale. In addition, biological samples (maternal sera and buccal cells) are collected to explore possible moderators for the treatment response. The primary data are collected at baseline and 11 weeks after randomization. The women are randomized 1:1 to the Stronger Together iCBT intervention, which combines seven weekly themes on a digital platform with weekly telephone coaching, or the educational control group. The CBT components include psychoeducation, behavioral activation, coping with social relationships, cognitive restructuring and preventing setbacks. The educational control group receives psychoeducational material about wellbeing during pregnancy. Both groups continue to receive standard treatment and maternity health check-ups. Discussion: We hypothesize that the Stronger Together iCBT intervention will reduce self-rated symptoms of antenatal depression, general and pregnancy-related anxiety, social phobia and stress. The intervention might offer an accessible and effective treatment for depressed pregnant women.