Outcomes of Mindful Mood Balance for Moms, online mindfulness-based cognitive therapy for perinatal depressive relapse prevention in the USA: a two-arm, single-blind, pragmatic randomised clinical trial

Background: Effective and accessible approaches to prevent depressive relapse and reduce symptoms are crucial for addressing the major public health problem of depression among perinatal women. We aimed to evaluate the effectiveness of Mindful Mood Balance (MMB) for Moms plus usual care (hereafter MMB for Moms)-a web-based mindfulness-based cognitive therapy programme customised for perinatal women-compared with usual care only, in reducing depressive relapse and symptoms.

Methods: This single-blind, randomised clinical trial was done across the USA, in euthymic pregnant women with recurrent depression who were on recent or current antidepressant medication. Recruitment occurred from March 7, 2019, to July 8, 2020 (data collection was completed Sept 12, 2021). Participants were randomly assigned to MMB for Moms, or usual care. Primary outcomes were reduction in depressive relapse risk and symptom burden, assessed using the Mini International Neuropsychiatric Interview and Patient Health Questionaire-9, respectively, across the study period. Outcomes were assessed from baseline until 6-months postpartum in three phases (intervention, end of intervention to delivery, and postpartum). The trial was registered with ClinicalTrials.gov, NCT03623620, and is complete.

Findings: Participants were recruited between March 7, 2019, and July 8, 2020. Data from 500 randomly assigned participants (mean age 32 years [SD 4·5] and mean 11·5 [2·8] weeks gestation), were analysed as the intention-to-treat sample. Of the 500 participants (249 assigned to MMB for Moms and 251 assigned to usual care), 383 [77%] provided assessment data at 3 months and 389 [78%] at 6 months postpartum. MMB for Moms had significantly lower risk of depressive relapse compared with usual care during the full trial period (up to 6 months postpartum): 81 (33%) of 249 participants assigned to MMB for Moms and 111 (44%) of 251 participants in usual care had depressive relapse (hazard ratio 0·74 [95% CI 0·56-0·99]; p=0·045; adjusted false discovery rate p=0·045). MMB for Moms was also associated with a significant reduction in depression symptom burden during the 12 week intervention phase (average decrease of 0·75 [SE 0·13] in the MMB for Moms group and 0·31 [0·13] in the usual care group) but not during the full trial period (average decrease of 0·61 [SE 0·18] in the MMB for Moms group and 0·54 [0·17] in the usual care group).

Interpretation: MMB for Moms resulted in lower risk of relapse compared with usual care, and lower depression symptom burden during the intervention phase, potentially offering an effective non-pharmacological support option for depression relapse prevention during the perinatal period with positive implications for public health practice.

Funding: US National Institutes of Health and US National Institute of Mental Health.