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

NCT07262801 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Sheryl M Green, Ph.D., C.Psych · St. Joseph's Healthcare Hamilton

  • Benicio N Frey, MD, PhD, FRCPC · St. Joseph's Healthcare Hamilton

  • Zoryana Babiy, M.Sc. · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07262801 on ClinicalTrials.gov