Mindfulness-Based Intervention for Treatment of Anxiety Disorders During the Postpartum Period: A 4-Week Proof-of-Concept Randomized Controlled Trial Protocol

Background/Objectives: Anxiety disorders (ADs) affect up to 20% of mothers in the postpartum period, characterized by psychological symptoms (e.g., emotion dysregulation; ER) and physical symptoms (e.g., disrupted bodily awareness). Although Cognitive Behavioural Therapy effectively reduces anxiety and mood symptoms, it shows limited efficacy in addressing ER difficulties and rarely targets interoceptive dysfunction-both common in postpartum ADs. This study evaluates the effectiveness of a brief mindfulness-based intervention in improving anxiety, ER, and interoception in mothers with postpartum ADs. A secondary aim is to examine changes in brain connectivity associated with these domains. Methods: This protocol describes a proof-of-concept randomized controlled trial involving 50 postpartum mothers with ADs. Participants will be randomized to receive either a 4-week mindfulness intervention plus treatment-as-usual (TAU) or TAU alone. Participants in the mindfulness + TAU group will complete a virtual 4-week group intervention adapted from Mindfulness-Based Cognitive Therapy. The TAU group will receive usual care for 4 weeks and then be offered the mindfulness intervention. Self-report measures of anxiety, ER, and interoception will be collected at baseline, post-intervention, and at a 3-month follow-up. Resting-state functional MRI will be conducted at baseline and post-intervention to assess functional connectivity changes. This trial has been registered on ClinicalTrials.gov (NCT07262801). Results: Improvements in anxiety, ER, and interoception are anticipated, along with decreased default mode network, and increased salience network connectivity post-intervention is hypothesized. Conclusions: This study will be the first to examine the combined psychological and neural effects of mindfulness in postpartum ADs, offering a potentially scalable mind-body treatment.