Recruiting

Mindfulness Intervention

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT07262801

Conditions

Postpartum Anxiety

Anxiety Disorders

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

4-week mindfulness-based intervention

Study Details

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

Study ID

NCT07262801

Start date

Dec, 2025

Status verified date

Dec, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 4-week mindfulness intervention

no intervention: Waitlist treatment as usual control

Interventions

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.

Primary outcome measure

  • State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

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

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

Zoryana Babiy, M.Sc.

babiyz@mcmaster.ca

Locations

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

Recruiting

Hamilton, Ontario, Canada

Contacts

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

Recruiting

Hamilton, Ontario, Canada

Contacts

Sheryl Green, PhD, C.Psych

905-522-1155sgreen@stjoes.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2025-12-04.