Abstract
BACKGROUND: Nearly 20% of women will be confronted with anxiety or depressive disorders during the perinatal period and this may lead to adverse outcomes for both mother and child. Cognitive behavioural therapy (CBT) is the psychological intervention with the most empirical support for the clinical management of anxiety and depressive disorders. Anxiety and depression frequently occur in women during the perinatal period, and there is growing evidence that internet-delivered CBT (iCBT) could be an acceptable and effective intervention. THIS WAY UP, an Australian digital mental health service, has developed a program for postnatal anxiety and depression. This study protocol aims to examine the acceptability and efficacy of a French-Canadian adaptation of the program. METHODS/DESIGN: The research team propose to conduct a mixed hybrid type 1 pragmatic randomized clinical trial and implementation study to replicate the findings of the trial conducted in Australia by Loughnan et al. (2019), as well as explore barriers and facilitators to potential large-scale implementation. TREATMENT AND CONTROL CONDITIONS: a) postnatal anxiety and depression iCBT program with three lessons to complete in a six-week period, added to treatment-as-usual (TAU); b) TAU. Participants will include French-speaking women with probable postnatal depression or anxiety as per the Generalized Anxiety Disorder-7 (GAD-7) or the Edinburgh Postnatal Depression Scale (EPDS). The primary outcome measures will be the GAD-7 and the EPDS. Secondary outcome measures will comprise self-reported instruments to evaluate psychological distress, quality of life, mother-child experience, and treatment experience. Qualitative interviews with participants and health professionals will provide insights on acceptability and delivery of the iCBT program. STATISTICAL ANALYSIS: Statistical analysis will follow intent-to-treat principles. A mixed model regression approach will be used to account for between- and within-subject variations in the analysis of the effects of iCBT compared to TAU only intervention. DISCUSSION: The study will generate important data of efficacy and acceptability to patients, clinicians, and decision-makers to inform the scaling-up of the postnatal iCBT intervention in Canada. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06778096, prospectively registered on 2025/01/16.