Maternal Mindfulness: Depression and Postpartum Pain
Purpose
This phase I clinical trial tests the feasibility and safety of a self-guided, mobile mindfulness-based intervention to reduce post-cesarean pain and prevent postpartum depression.
Conditions
- Depression, Unipolar
- Pain, Postoperative
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Criteria
1. Women must self-identify as Latina/Latinx/Hispanic, Asian, African American, or
non-Hispanic White.
2. Scheduled to undergo a planned cesarean delivery.
3. Be of 18-45 years of age
4. Have a singleton pregnancy
5. Score between 5 and 13 on the Edinburgh Postnatal Depression Scale (EPDS)
6. A history of depression
7. Have no chronic pain condition (e.g., fibromyalgia)
8. Own a computer, smartphone, or tablet
9. Have a reliable internet access to complete the online surveys.
10. Be proficient in English or Spanish.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The 8-week intervention will begin in the first week post-cesarean delivery. Before the intervention begins at week 1, participants are requested to complete Numerical Pain Rating Scale (NPRS), Edinburgh Postnatal Depression Scale (EPDS), Data Collection Worksheet (DCW), Five Facet Mindfulness Questionnaire (FFMQ), Mindful Attention Awareness Scale (MAAS), Postpartum Depression Predictor (PDPI- Postpartum), Self-Acceptance Scale for Postpartum Women (SAS-PPW), Flourishing scale (FS), and Listening to Mothers California survey, Postpartum Bonding Questionnaire (PBQ) which may take approximately 20 minutes to complete (see Section 23, item 23.3 for all measures). Each intervention week, participants will engage in: A 5-10-minute self-guided mindfulness-based stress reduction (MBSR) practice through audio recordings through Canvas Free for teacher based on the submitted scripts. Based on the submitted scripts, a 5-minute self-guided audio home practice session will be provided.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Mindfulness |
Receiving mobile, self-guided mindfulness intervention |
|
|
No Intervention Treatment as usual with monitoring |
Receiving treatment as usual with monitoring by study PI and investigators. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Illinois at Urbana-Champaign
Detailed Description
Postpartum pain affects approximately 92% of women and is a risk factor for postpartum depression (PPD). Cesarean delivery is associated with elevated risk for both postpartum pain and PPD, and women who experience persistent postpartum pain are at increased risk of developing depressive symptoms. PPD may contribute to withdrawal, emotional detachment, and hostility, which can negatively affect mother-infant interactions, including breastfeeding. These risks underscore the urgent need for an effective non-pharmacologic intervention to reduce post-cesarean delivery pain and prevent PPD. The objective of this study is to optimize a mobile, self-guided 8-week Mindfulness-Based Stress Reduction (MBSR) intervention for non-depressed women at risk for PPD who have a planned cesarean delivery. The investigators will conduct a single-group open trial of women (N = 20), including Latinas (English- and Spanish-speaking), Asian, African American, and non-Hispanic White women. The study is testing two primary hypotheses: (1) the 8-week mobile MBI will demonstrate high feasibility and acceptability among a diverse sample of women, shown by meeting target recruitment, enrollment, and retention benchmarks and (2) participants will demonstrate reductions in reported pain scores and depressive symptoms from pre- to post-intervention. In addition, the study will evaluate recruitment, enrollment, dosage, safety, and retention metrics and survey participants about intervention features, facilitators, barriers, satisfaction, and recommendations. Participants will be recruited through community partners, including the Champaign-Urbana Public Health District and the University YMCA, using flyers, partner-supported distribution of study information, and email announcements. Interested individuals will complete an online eligibility screener accessed through a QR code or URL on recruitment materials. Eligible participants will include women with an Edinburgh Postnatal Depression Scale score of 5-13 who have a planned singleton cesarean delivery, are within 18-45 years of age, and have no chronic pain condition. Individuals who meet initial eligibility criteria will be contacted by phone to confirm participant authenticity, then sent a REDCap link to complete electronic consent and a background questionnaire. After enrollment, participants will meet briefly with a trained research assistant to review access to the intervention platform and address any questions or concerns. Recruitment and enrollment will occur during the third trimester of pregnancy, and the intervention will begin during the first week following cesarean delivery.
