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

NCT07262801 | Recruiting

• 1 other identifier: PPA-Mindfulness-RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postpartum Anxiety; Anxiety Disorders

Keywords

postpartum anxiety; anxiety disorders; mothers; mindfulness; mindfulness-based intervention; emotion regulation; interoception; fMRI; resting state functional connectivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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).

Other Outcomes (1)

• 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.

Study Arms (2)

4-week mindfulness intervention

EXPERIMENTAL

Behavioral: 4-week mindfulness-based intervention

Waitlist treatment as usual control

NO INTERVENTION

Interventions

4-week mindfulness-based intervention BEHAVIORAL

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.

4-week mindfulness intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (2)

Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

RECRUITING

Women's Health Concerns, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

RECRUITING

Related Publications (1)

• Babiy Z, Frey BN, McCabe RE, Bieling PJ, Minuzzi L, Puccinelli C, Green SM. Mindfulness-Based Intervention for Treatment of Anxiety Disorders During the Postpartum Period: A 4-Week Proof-of-Concept Randomized Controlled Trial Protocol. Brain Sci. 2026 Jan 13;16(1):88. doi: 10.3390/brainsci16010088.

  PMID: 41594809 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Sheryl M Green, Ph.D., C.Psych

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

• Benicio N Frey, MD, PhD, FRCPC

  St. Joseph's Healthcare Hamilton

  STUDY CHAIR

• Zoryana Babiy, M.Sc.

  McMaster University

  STUDY DIRECTOR

Central Study Contacts

Sheryl M Green, Ph.D., C.Psych

CONTACT

905-522-1155; sgreen@stjosham.on.ca

Zoryana Babiy, M.Sc.

CONTACT

babiyz@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sheryl Green, Ph.D., C.Psych

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

CA (2)