Cognitive Behavioral Therapy for Procedural Anxiety in High-Risk Pregnancies

Recruiting at 2 trial locations

Overseen By Allison Dempsey, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Delivery at outside hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goals of this study are to determine the feasibility and efficacy of a brief, single-session cognitive-behavioral intervention for reducing preoperative and postoperative anxiety and for determining satisfaction with the delivery process in pregnant women scheduled for Cesarean delivery due to complications with their pregnancy. This will be done through a combination of psychoeducation and exposure therapy, where the participants will be walked through the steps of a Cesarean delivery in an operating room that mimics where the patient would actually be delivering. Follow-up will occur during the immediate and extended postpartum periods to determine satisfaction and levels of anxiety.

Research Team

Allison Dempsey, PhD

Principal Investigator

Children's Hospital Colorado

Eligibility Criteria

This trial is for pregnant women with high-risk pregnancies due to fetal complications, who are scheduled for Cesarean deliveries. It aims to help those experiencing significant anxiety about the procedure.

Inclusion Criteria

Fetal Anomaly/Complication

Planned Cesarean Delivery

Exclusion Criteria

Delivery planned at outside hospital

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive a brief, single-session cognitive-behavioral intervention involving psychoeducation and exposure therapy to reduce preoperative anxiety.

1 hour

1 visit (in-person)

Usual Care

Participants receive the standard care, including a meeting with the anesthesiologist to review anesthetic techniques and ask questions.

1 session

1 visit (in-person)

Immediate Postpartum Follow-up

Participants are monitored for satisfaction with delivery and anxiety levels immediately after delivery.

<14 days post-delivery

Extended Postpartum Follow-up

Participants are monitored for post-traumatic stress symptoms and anxiety levels in the extended postpartum period.

6-8 weeks post-delivery

Treatment Details

Interventions

• Exposure Intervention

Trial Overview The study tests a single-session cognitive-behavioral intervention against usual care. The intervention includes psychoeducation and exposure therapy, simulating the steps of a Cesarean delivery in an operating room setting.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

Participants randomized to the Care as Usual condition will receive the typical standard of care that is offered in the center. This involves the anesthesiologist meeting with the patient during a delivery planning meeting to provide patients with the opportunity to review anesthetic technique and ask questions.

Group II: Exposure Intervention Experimental Treatment 1 Intervention

Participants randomized to receive the Exposure Intervention will be scheduled to come to clinic for a 1-hour session for the intervention. During this time, they will receive psychoeducation and behavioral exposure to the Cesarean section procedure.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+