Postpartum AnxietyNCT07262801
Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period
A study testing 4-week mindfulness-based intervention in people with Postpartum Anxiety and Anxiety Disorders, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Anxiety, Anxiety Disorders
- What is being tested?
- 4-week mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Zoryana Babiy, M.Sc. contact
Canada2 sites, 2 recruiting
- Recruiting
Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Sheryl M Green, 905-522-1155 ext. 33672, sgreen@stjoes.ca
- Recruiting
Women's Health Concerns, St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Sheryl Green, PhD, C.Psych, 905-522-1155 ext. 33672, sgreen@stjoes.ca
About this study
Official title: Evaluating the Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period: A Proof of Concept Trial
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
- Being tested
- 4-week mindfulness-based intervention
- Keywords
- postpartum anxiety, anxiety disorders, mothers, mindfulness, mindfulness-based intervention, emotion regulation, interoception, fMRI, resting state functional connectivity
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-week mindfulness-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 4-week mindfulness intervention | Experimental | Not described Receives: Behavioral: 4-week mindfulness-based intervention |
| Waitlist treatment as usual control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Measured: 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 (12)
Difficulties in Emotion Regulation Scale (DERS)
Measured: 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).
Penn State Worry Questionnaire (PSWQ)
Measured: 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).
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Measured: 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).
Edinburgh Postnatal Depression Scale (EPDS)
Measured: 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).
World Health Organization Quality of Life Scale (WHOQoL)
Measured: 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).
Perceived Stress Scale (PSS)
Measured: 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).
Multidimensional Assessment of Interoceptive Awareness 2 (MAIA-2)
Measured: 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).
Interoceptive Sensitivity and Attention Questionnaire (ISAQ)
Measured: 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).
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Measured: 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).
Postpartum Bonding Questionnaire (PBQ)
Measured: 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).
Social Provisions Scale (SPS)
Measured: 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).
The Dyadic Adjustment Scale (DAS)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Green, St. Joseph's Healthcare Hamilton
- Investigators
- Sheryl M Green, Ph.D., C.Psych, Principal investigator, St. Joseph's Healthcare HamiltonBenicio N Frey, MD, PhD, FRCPC, Study chair, St. Joseph's Healthcare HamiltonZoryana Babiy, M.Sc., Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262801
- Sponsor's protocol ID
- PPA-Mindfulness-RCT
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Experimental group participants will be given the option to consent to having their de-identified REDCap questionnaires and fMRI scans data shared with the Canadian Biomarker Integration Network in Depression (CAN-BIND). CAN-BIND is a standardized research platform that supports large-scale collaboration by collecting and curating data from both healthy and clinical populations. If one chooses to provide this optional consent, their data may be used to support future ethically approved research projects. All shared data will be encrypted and de-identified to protect privacy as CAN-BIND follows strict ethical and data security standards, comparable to those at St. Joseph's Healthcare Hamilton.
Publications
Babiy Z, Frey BN, McCabe RE, Bieling PJ, Minuzzi L, Puccinelli C, Green SM. Mindfulness-Based Intervention for Treatment of Anxiety Disorders During the Postpartum Period: A 4-Week Proof-of-Concept Randomized Controlled Trial Protocol. Brain Sci. 2026 Jan 13;16(1):88. doi: 10.3390/brainsci16010088.
PubMed 41594809
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period: A Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT07262801
- Acronym / sponsor ID
- PPA-Mindfulness-RCT
- Conditions
- Postpartum Anxiety, Anxiety Disorders
- Keywords
- postpartum anxiety, anxiety disorders, mothers, mindfulness, mindfulness-based intervention, emotion regulation, interoception, fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-week mindfulness intervention | Experimental | Behavioral: 4-week mindfulness-based intervention |
| Waitlist treatment as usual control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-week mindfulness-based interventionThis 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. | Behavioural | 4-week mindfulness intervention |
Primary outcome
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).
12 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 41594809Babiy Z, Frey BN, McCabe RE, Bieling PJ, Minuzzi L, Puccinelli C, Green SM. Mindfulness-Based Intervention for Treatment of Anxiety Disorders During the Postpartum Period: A 4-Week Proof-of-Concept Randomized Controlled Trial Protocol. Brain Sci. 2026 Jan 13;16(1):88. doi: 10.3390/brainsci16010088.
- Individual participant dataSharing planned: Yes. Experimental group participants will be given the option to consent to having their de-identified REDCap questionnaires and fMRI scans data shared with the Canadian Biomarker Integration Network in Depression (CAN-BIND). CAN-BIND is a standardized research platform that supports large-scale collaboration by collecting and curating data from both healthy and clinical populations. If one chooses to provide this optional consent, their data may be used to support future ethically approved research projects. All shared data will be encrypted and de-identified to protect privacy as CAN-BIND follows strict ethical and data security standards, comparable to those at St. Joseph's Healthcare Hamilton.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zoryana Babiy, M.Sc. contact
Sheryl M Green, Ph.D., C.Psych principal investigator
St. Joseph's Healthcare Hamilton
Benicio N Frey, MD, PhD, FRCPC study chair
St. Joseph's Healthcare Hamilton
Zoryana Babiy, M.Sc. study director
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-week mindfulness-based intervention in people with Postpartum Anxiety and Anxiety Disorders, run by St. Joseph's Healthcare Hamilton at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheryl M Green, Ph.D., C.Psych (905-522-1155 ext. 33672, sgreen@stjosham.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.