Mindfulness-Based Intervention for Treatment of Anxiety Disorders During the Postpartum Period: A 4-Week Proof-of-Concept Randomized Controlled Trial Protocol
Zoryana Babiy, Benício N. Frey, Randi E. McCabe, Peter Bieling, Luciano Minuzzi, Christina Puccinelli, S. M. Green
Brain Sciences January 13, 2026 DOI: 10.3390/brainsci16010088 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 50 |
| Population | Postpartum mothers with anxiety disorders |
| Duration | 4-week intervention, 3-month follow-up |
| Topics | Anxiety Meditation |
| Keywords | Randomized controlled trial Mood Intervention counseling Cognition Postpartum period Cognitive behavioral therapy Physical therapy Clinical psychology Affect linguistics Cognitive therapy Interoception |
| Citations | 1 |
| Registration | NCT07262801 |
| Key findings | The protocol hypothesizes that a brief mindfulness intervention plus treatment-as-usual will improve anxiety, emotion regulation, and interoception in postpartum mothers with anxiety disorders, with associated changes in brain connectivity. |
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.
Comparable studies
Other randomized controlled trials on anxiety, most cited first.
Citations in the library
Cites 18
- Mindfulness meditation training alters cortical representations of interoceptive attention Social Cognitive and Affective Neuroscience June 11, 2012
- Neural mechanisms of symptom improvements in generalized anxiety disorder following mindfulness training NeuroImage: Clinical 2013
- Mindfulness-Based Cognitive Therapy: Theory and Practice The Canadian Journal of Psychiatry February 1, 2012
- Mindfulness meditation training alters stress-related amygdala resting state functional connectivity: a randomized controlled trial Social Cognitive and Affective Neuroscience June 5, 2015
- Mindfulness meditation increases default mode, salience, and central executive network connectivity Scientific Reports August 2, 2022
and 13 more in the library