Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period

Evaluating the Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period: A Proof of Concept Trial

Postpartum anxiety (PPA) affects up to 20% of mothers in the first year after delivery, with mothers often reporting both psychological and physical symptoms. Present non-pharmacological interventions are effective at improving some psychological aspects of PPA such as anxiety, depressive mood, and distress. However, current interventions are not effective in improving emotion regulation (ER), something that many with PPA experience impairment in. Current interventions also seldom target the physical aspects of anxiety, such as bodily awareness - sensing and understanding internal signals in the body (e.g., sensing a fast heartbeat). There is a link between ER and bodily awareness, however psychological interventions that target both these aspects have not been investigated in the PPA population. As a result, a mind-body intervention targeting both ER and bodily awareness is needed to offer a more holistic treatment option.

The purpose of the proposed study is to test the effectiveness of a 4-week mindfulness intervention on anxiety symptoms, ER, and bodily awareness in those with PPA. We will use self-report questionnaires alongside brain imaging (functional magnetic resonance imaging; fMRI) to evaluate the effectiveness. Combining both subjective and objective measures will provide greater confidence in our findings, ensuring a more comprehensive understanding of the intervention's impact. Self-report questionnaires will be administered at enrolment, immediately post-intervention, and 4 weeks post-intervention. Brain imaging will be conducted at enrolment and immediately post-intervention. We believe this intervention will lead to improvements in anxiety symptoms, ER, and bodily awareness on the questionnaires and fMRI scans.

If effective, the proposed mindfulness intervention will target a broader range of psychological and physical symptoms, and reduce the negative impact of PPA on mothers and their infants in Canada and beyond.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders; Postpartum Anxiety
• Intervention / Treatment: Behavioral: 4-week mindfulness-based intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheryl M Green, Ph.D., C.Psych; Phone Number: 33672 905-522-1155; Email: sgreen@stjosham.on.ca
• Study Contact Backup: Name: Zoryana Babiy, M.Sc.; Email: babiyz@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton
      • Contact: Sheryl M Green; Phone Number: 33672 905-522-1155; Email: sgreen@stjoes.ca
    • Hamilton, Ontario, Canada
      • Recruiting
      • Women's Health Concerns, St. Joseph's Healthcare Hamilton
      • Contact: Sheryl Green, PhD, C.Psych; Phone Number: 33672 905-522-1155; Email: sgreen@stjoes.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• mothers/birthing parents 18 years and older who are between 0-12 months postpartum
• principal diagnosis of an anxiety disorder as per the Diagnostic Assessment Research Tool (DART; Schneider et al., 2022), with or without comorbid depression
• no concurrent psychological treatment
• not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; McQueen et al., 2016) and b) medications remain stable throughout the study
• fluent in English, minimal grade 8 reading level.

Exclusion Criteria:

• severe depression/suicidality requiring acute intervention
• women with psychotic or current alcohol or substance use disorders
• suffering from severe claustrophobia
• metallic objects in body (metal implants, pacemakers)
• currently pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-week mindfulness intervention	Behavioral: 4-week mindfulness-based intervention; This is the first mindfulness-based intervention specifically designed for postpartum mothers and birthing parents with clinical anxiety. The protocol is adapted from Mindfulness-Based Cognitive Therapy for Depression (by J. Mark G. Williams, John D. Teasdale, and Zindel Segal), and is explicitly tailored to address anxiety disorders during the postpartum period. Most existing mindfulness-based protocols primarily target anxiety during pregnancy, are suitable for both clinical and subclinical levels of anxiety, and are commonly applied to both postpartum depression and anxiety populations.
No Intervention: Waitlist treatment as usual control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).

Secondary Outcome Measures

Outcome Measure	Time Frame
Difficulties in Emotion Regulation Scale (DERS)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Penn State Worry Questionnaire (PSWQ)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Generalized Anxiety Disorder 7-Item Scale (GAD-7)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Edinburgh Postnatal Depression Scale (EPDS)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
World Health Organization Quality of Life Scale (WHOQoL)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Perceived Stress Scale (PSS)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Multidimensional Assessment of Interoceptive Awareness 2 (MAIA-2)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Interoceptive Sensitivity and Attention Questionnaire (ISAQ)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Postpartum Bonding Questionnaire (PBQ)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
Social Provisions Scale (SPS)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).
The Dyadic Adjustment Scale (DAS)	Administered at baseline (at enrolment), post-intervention (immediately after the 4 week intervention), and at the 3 months follow-up (3 months after intervention completion).

Other Outcome Measures

Outcome Measure	Time Frame
Resting State Functional Connectivity (fMRI)	Completed at baseline (at enrolment) and post-intervention (immediately after the 4 week intervention), in participants randomized to the experimental group only.

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Sheryl M Green, Ph.D., C.Psych, St. Joseph's Healthcare Hamilton; Study Chair: Benicio N Frey, MD, PhD, FRCPC, St. Joseph's Healthcare Hamilton; Study Director: Zoryana Babiy, M.Sc., McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness; fMRI; mothers; anxiety disorders; emotion regulation; mindfulness-based intervention; interoception; postpartum anxiety; resting state functional connectivity
• Additional Relevant MeSH Terms: Mental Disorders; Behavior; Social Behavior; Self-Control; Anxiety Disorders; Emotional Regulation
• Other Study ID Numbers: PPA-Mindfulness-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Experimental group participants will be given the option to consent to having their de-identified REDCap questionnaires and fMRI scans data shared with the Canadian Biomarker Integration Network in Depression (CAN-BIND). CAN-BIND is a standardized research platform that supports large-scale collaboration by collecting and curating data from both healthy and clinical populations. If one chooses to provide this optional consent, their data may be used to support future ethically approved research projects. All shared data will be encrypted and de-identified to protect privacy as CAN-BIND follows strict ethical and data security standards, comparable to those at St. Joseph's Healthcare Hamilton.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No