To evaluate the effectiveness of a web-based secondary prevention programme for postpartum depression, delivered with or without telephone support, compared with usual care.

We first conducted a randomised controlled superiority trial to test whether the web-based Parents and Babies programme (Toi, Moi, Bébé; TMB) delivered with motivational telephone support (ie, coaching) was superior to the fully automated programme (ie, self-help). TMB incorporated classic and third-wave cognitive–behavioural therapy components and psychoeducation. Then, we tested whether TMB (both treatment modalities combined) was superior to usual care. The usual care comparison group was drawn from the CONCEPTION prospective pan-Canadian perinatal cohort (N=592).

A remote study based at Sainte-Justine Hospital Centre, Quebec, Canada.

Web-based intervention programme participants were women aged ≥14 years at 12–25 weeks’ gestation, with subclinical to moderate clinical Edinburgh Postnatal Depression Scale (EPDS) scores: 9–16. Exclusion criteria were psychosis and self-reported substance abuse. The usual care comparison group was pregnant women ≥18 years old. All participants were living in Canada at study inception.

The primary outcome was EPDS scores at 3 months post partum, accounting for baseline EPDS scores and depression events defined as EPDS ≥13 at 3 months post partum. The secondary outcomes were EPDS scores at 6 months post partum, depression events (EPDS≥13) at 6 months post partum, anxiety symptoms (Generalised Anxiety Disorder 7-item Scale, GAD-7) at 3 and 6 months post partum, accounting for baseline scores for the continuous outcomes; as well as the number of completed intervention modules and well-being scores (WHO 5-Item Well-being Index) at 3 months post partum.

We randomised 510 participants to TMB self-help (n=255) or TMB with coaching (n=255); 211 and 214 participants, respectively, were included in the complete-case intention-to-treat analyses. At baseline, 91% lived with a partner, 71% were university graduates and 42% self-reported GAD-7≥10. Randomisation was successful. First, TMB with coaching was not superior to TMB self-help: at 3 months post partum, EPDS scores were TMB self-help (mean 8.0±4.3) vs TMB with coaching (mean 8.6±4.5); effect size was 0.01 (95% CI 0.00 to 0.03; p=0.16). Second, TMB (regardless of intervention arm) was superior to usual care: in adjusted regression models, EPDS scores were 6.2 units lower (per SD, 95% CI –8.2 to –4.3) in TMB (both treatment modalities combined) than in usual care; and proportions of depression events were 4.7 units lower (per SD on the logit scale, 95% CI –6.6 to –2.7) in TMB (combined) than in usual care. No other group differences were observed.

Our findings suggest that, in women with subclinical to moderate clinical antenatal depressive symptoms, receiving a web-based cognitive–behavioural therapy-based programme in addition to usual care can reduce depression postnatally.

NCT05110456.

Primary aldosteronism (PA) is a highly prevalent but underdiagnosed cause of hypertension, characterised by renin-independent aldosterone production. PA is associated with a higher incidence of cardiovascular and kidney complications, independent of blood pressure. Although mineralocorticoid receptor antagonists (MRAs) are the standard treatment when surgical adrenalectomy is not clinically indicated or possible, response is typically monitored using indirect clinical markers such as blood pressure and potassium. Emerging evidence suggests that achieving renin unsuppression may result in better outcomes, yet this hypothesis has not been tested in a randomised controlled trial. The objective of this trial is to evaluate whether a renin-guided MRA titration strategy improves biochemical efficacy compared with standard titration in patients with PA.

This is a multicentre, open-label, pragmatic randomised controlled trial in four academic centres in Canada. 58 adults with confirmed PA, suppressed renin at baseline, and an indication for long-term MRA therapy will be enrolled. Key exclusion criteria include prior MRA use, estimated glomerular filtration rate 4.8 mmol/L and pregnancy. The primary endpoint is the proportion of participants with unsuppressed renin at 12 months. Secondary outcomes include blood pressure, left ventricular mass, kidney function, MRA dose, quality of life and various safety outcomes. Participants will be randomised 1:1 to a renin-guided titration strategy or standard care. In the intervention arm, MRAs will be titrated to achieve unsuppressed renin (>10 ng/L, >15 mIU/L or >1.0 ng/mL/hour). The control arm follows usual clinical practice, without serial renin measurements during dose titration. All participants will be followed for 12 months, with visits at 1, 3, 6, 9 and 12 months. Analysis will follow the intention-to-treat principle and use Fisher’s exact test for proportions, mixed-effects models for continuous outcomes and Kaplan-Meier estimates for time-to-event data. The trial is powered to detect a 42% absolute difference in the primary outcome (40% in the control groups vs 82% in the experimental group; alpha 0.05, 80% power, 15% loss to follow-up). This trial will be the first to prospectively assess the biochemical efficacy of a renin-guided MRA titration strategy in PA. If successful, the next phase will be to assess the efficacy of this strategy on important surrogate outcomes and patient-reported outcome measures.

This study was approved by the Research and Ethics Board of the Centre intégré universitaire de santé et de services sociaux du Nord-de-l’Île-de-Montréal (project number 2024-2727). All the participating sites have received the ethics approval. The findings will be disseminated through national and international presentations and peer-reviewed publications.

NCT06108427.