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NCT Number: NCT07262801

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Difficulties in Emotion Regulation Scale (DERS)

    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).

  2. Penn State Worry Questionnaire (PSWQ)

    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).

  3. Generalized Anxiety Disorder 7-Item Scale (GAD-7)

    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).

  4. Edinburgh Postnatal Depression Scale (EPDS)

    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).

  5. World Health Organization Quality of Life Scale (WHOQoL)

    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).

  6. Perceived Stress Scale (PSS)

    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).

  7. Multidimensional Assessment of Interoceptive Awareness 2 (MAIA-2)

    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).

  8. Interoceptive Sensitivity and Attention Questionnaire (ISAQ)

    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).

  9. Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)

    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).

  10. Postpartum Bonding Questionnaire (PBQ)

    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).

  11. Social Provisions Scale (SPS)

    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).

  12. The Dyadic Adjustment Scale (DAS)

    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).

Other outcomes

  1. Resting State Functional Connectivity (fMRI)

    Time frame: Completed at baseline (at enrolment) and post-intervention (immediately after the 4 week intervention), in participants randomized to the experimental group only.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

905-522-1155 ext. 33672

Zoryana Babiy, M.Sc.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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