Anxiety Disorders, Postpartum Anxiety
Conditions
Keywords
postpartum anxiety, anxiety disorders, mothers, mindfulness, mindfulness-based intervention, emotion regulation, interoception, fMRI, resting state functional connectivity
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.
Interventions
BEHAVIORAL4-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.
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) | 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
| Measure | Time frame |
|---|---|
| Difficulties in Emotion Regulation Scale (DERS) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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
| Measure | Time frame |
|---|---|
| Resting State Functional Connectivity (fMRI) | Completed at baseline (at enrolment) and post-intervention (immediately after the 4 week intervention), in participants randomized to the experimental group only. |
Countries
Canada
Contacts
Primary ContactSheryl M Green, Ph.D., C.Psych
Backup ContactZoryana Babiy, M.Sc.
Outcome results
None listed