Mindfulness and body-awareness program for postpartum anxiety
Evaluating the Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period: A Proof of Concept Trial
This study will test a 4-week mindfulness-based program to see if it helps mothers in the first year after delivery with anxiety improve emotion regulation and awareness of bodily signals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | St. Joseph's Healthcare Hamilton Academic / other |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT07262801 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls mothers 0–12 months postpartum with a primary anxiety disorder to receive a 4-week mindfulness-based intervention targeting both emotion regulation and bodily awareness. Participants are screened for exclusions including severe depression/suicidality, psychosis, active substance use disorders, current pregnancy, severe claustrophobia, or disqualifying metal implants. Psychological outcomes (anxiety, mood, emotion regulation) and physiological or interoceptive measures of bodily awareness will be collected before and after the program. The intervention is delivered in-person at the Women's Health Concerns Clinic at St. Joseph's Healthcare Hamilton in Hamilton, Ontario.
Who should consider this trial
Good fit: Mothers or birthing parents aged 18 and older who are 0–12 months postpartum with a principal diagnosis of an anxiety disorder, fluent in English, not in concurrent psychological treatment, and either medication-free or on a stable psychiatric medication regimen are ideal candidates.
Not a fit: Those with severe depression or active suicidality, current psychosis or substance use disorders, pregnant people, and individuals with severe claustrophobia or metal implants are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could offer postpartum mothers a non-drug way to reduce anxiety symptoms and improve emotion regulation and bodily awareness.
How similar studies have performed: Mindfulness-based programs have shown benefits for anxiety and mood in postpartum and general populations, but combining targeted emotion-regulation and bodily-awareness training specifically for postpartum anxiety is a novel approach with limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamilton, Ontario and 1 other locations
- 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)
Study contacts
- Principal investigator: Sheryl M Green, Ph.D., C.Psych — St. Joseph's Healthcare Hamilton
- Study coordinator: Sheryl M Green, Ph.D., C.Psych
- Email: sgreen@stjosham.on.ca
- Phone: 905-522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.