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

Recruiting now · Not applicable

Conditions studied: Postpartum Anxiety, Anxiety Disorders

In brief

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.

Key facts

Study ID

NCT07262801

Run by

St. Joseph's Healthcare Hamilton

People needed

50

Starts

2025-12-01

Expected to finish

2026-09-01

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (enrolling)
• Women's Health Concerns, St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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