Preventing mood, anxiety, and trauma after cesarean delivery
Official title: Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery
Run by University of Colorado, Denver · NCT06949813 · Data updated 2026-11-12
This project tests a one-hour, single-session in‑operating-room intervention to try to prevent mood, anxiety, and trauma symptoms in pregnant patients who are scheduled for a cesarean delivery.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | October 13, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT06949813 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant patients 22–37 weeks with a high‑risk pregnancy who are admitted antepartum for at least three days and have an anticipated cesarean delivery at the University of Colorado.
✕Probably not a fit
Patients who cannot consent, have medical contraindications to participation, or have an anticipated cesarean within seven days of enrollment are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized pilot of a 1-hour, single-session intervention (CARE) that combines brief psychoeducation about anxiety sensitivity with in‑vivo exposure to the operating room and cesarean procedures. Participants are pregnant patients (22–37 weeks) with high‑risk pregnancies who are admitted antepartum for at least three days and have an anticipated cesarean at the University of Colorado. The intervention is compared with a control interaction (including clinician FaceTime contact) and outcomes include changes in anxiety sensitivity, preoperative anxiety, postpartum mood/anxiety/trauma symptoms, and postoperative opioid use with follow-up into the early postpartum period. The study builds on prior non‑obstetric single‑session work and an initial pilot RCT that showed substantial reductions in preoperative and postpartum anxiety and lower opioid use.
Why it matters
Potential benefit: If successful, this low-cost, single-session approach could reduce perioperative anxiety, lower postpartum mood/anxiety/trauma symptoms, and decrease postoperative opioid use after cesarean delivery.
How similar studies have gone: Single‑session interventions targeting anxiety sensitivity have prevented anxiety and trauma symptoms in non‑obstetric populations, and an earlier pilot RCT of CARE among patients with anomalous fetuses reported large reductions in preoperative and postpartum anxiety and in opioid use.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant Patients at 22-37 weeks gestation * Single or multiple gestation * Nulliparous or multiparous (with prior vaginal or cesarean delivery) * Antepartum admission for at least 3 days * High-risk pregnancy due to maternal/fetal comorbidities * Anticipated cesarean delivery at the University of Colorado Exclusion Criteria: * Lack of capacity to consent * Medical factors prohibiting participation in the intervention as determined by the inpatient obstetric medical team. * Anticipated cesarean within 7 days of enrollment
Where it's running
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University of Colorado Hospital
Aurora, Colorado, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.