Depression, UnipolarMaMiDaPPNCT05400382
Maternal Mindfulness: Depression and Postpartum Pain
A study testing Mindfulness in people with Depression, Unipolar and Pain, Postoperative, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Unipolar, Pain, Postoperative
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Mar 2028
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
- Women must self-identify as Latina/Latinx/Hispanic, Asian, African American, or non-Hispanic White.
- Scheduled to undergo a planned cesarean delivery.
- Be of 18-45 years of age
- Have a singleton pregnancy
- Score between 5 and 13 on the Edinburgh Postnatal Depression Scale (EPDS)
- A history of depression
- Have no chronic pain condition (e.g., fibromyalgia)
- Own a computer, smartphone, or tablet
- Have a reliable internet access to complete the online surveys.
- Be proficient in English or Spanish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820
Sandraluz Lara-Cinisomo, Ph.D, 217-300-3512, laracini@illinois.edu
About this study
Official title: Maternal Mindfulness to Prevent Depression and Reduce Postpartum Pain (MaMiDaPP) Intervention
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.
Read the 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.
- Conditions
- Depression, Unipolar, Pain, Postoperative
- Being tested
- Mindfulness
- Keywords
- postpartum, depression, pain, cesarean
- Medical subject headings
- Depressive Disorder, Pain, Postoperative, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Also called Mindfulness meditation
Meditation training to help reduce stress and reactivity to pain and other stressors.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Receiving mobile, self-guided mindfulness intervention Receives: Behavioral: Mindfulness |
| Treatment as usual with monitoring | No intervention | Receiving treatment as usual with monitoring by study PI and investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Numerical Pain Rating Scale (NPRS); Participant reported pain intensity (0 is equivalent to no pain and 10 indicates the worst possible pain) and pain unpleasantness (0 is equivalent to not at all unpleasant and 10 indicates the most unpleasant feeling possible)
Measured: 1 week postpartum and 8 weeks postpartum
Secondary outcomes (1)
Postpartum depression
Edinburgh Postnatal Depression Scale (EPDS); participant reported depressive symptoms. Those who score above 13 are likely to be suffering from a depressive illness of varying severity.
Measured: 1 week postpartum and 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Dec 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, UnipolarStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Illinois University, Arrowhead Regional Medical Center, University of Utah
- Responsible party
- Principal investigator, Sandraluz Lara-Cinisomo, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400382
- Sponsor's protocol ID
- MaMiDaPP
- Acronym
- MaMiDaPP
- Status last verified
- Aug 2026
- First submitted
- 27 May 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Mindfulness to Prevent Depression and Reduce Postpartum Pain (MaMiDaPP) Intervention
- ClinicalTrials.gov ID
- NCT05400382
- Acronym / sponsor ID
- MaMiDaPP / MaMiDaPP
- Conditions
- Depression, Unipolar, Pain, Postoperative
- Keywords
- postpartum, depression, pain, cesarean
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Southern Illinois University, Arrowhead Regional Medical Center, University of Utah
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 1 Jun 2022 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessReceiving mobile, self-guided mindfulness intervention |
| Treatment as usual with monitoring | No intervention | –Receiving treatment as usual with monitoring by study PI and investigators. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| MindfulnessAlso: Mindfulness meditationMeditation training to help reduce stress and reactivity to pain and other stressors. | Behavioural | Mindfulness |
Primary outcome
Post-operative pain
Time frame: 1 week postpartum and 8 weeks postpartum
Numerical Pain Rating Scale (NPRS); Participant reported pain intensity (0 is equivalent to no pain and 10 indicates the worst possible pain) and pain unpleasantness (0 is equivalent to not at all unpleasant and 10 indicates the most unpleasant feeling possible)
1 secondary outcome
Postpartum depression
Time frame: 1 week postpartum and 8 weeks postpartum
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 6 Aug 2026.
- Individual participant dataSharing planned: Undecided. To be determined
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Depression, Unipolar and Pain, Postoperative, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Sandraluz Lara-Cinisomo, Ph.D. (217-300-3512, laracini@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 1 week postpartum and 8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.