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

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

Overview

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.

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 le

Primary outcome measures

• 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 outcome measures (12)

• 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).]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 2 centers

• Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton — Hamilton
• Women's Health Concerns, St. Joseph's Healthcare Hamilton — 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. PMID 41594809

Identifiers

NCT: NCT07262801 · PPA-Mindfulness-RCT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗