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

A proof-of-concept randomized controlled trial will test whether a 4-week mindfulness-based intervention, added to treatment-as-usual, improves anxiety, emotion regulation, and interoception in 50 postpartum mothers with anxiety disorders. The intervention is adapted from Mindfulness-Based Cognitive Therapy and delivered virtually. Self-report measures 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. The authors hypothesize improvements in anxiety, emotion regulation, and interoception, along with decreased default mode network and increased salience network connectivity. This is the first study to examine combined psychological and neural effects of mindfulness in postpartum anxiety disorders.

Study at a glance

Abstract

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.