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Cognitive Behavioral Therapy for Procedural Anxiety in High-Risk Pregnancies

N/A

Recruiting

Led By Allison Dempsey, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-8 weeks post-delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a cognitive-behavioral intervention to see if it can reduce anxiety for pregnant women scheduled for Cesarean delivery. The intervention will include psychoeducation and exposure therapy in an operating room that mimics where the patient would actually be delivering. Follow-up will occur post-delivery to determine satisfaction and levels of anxiety.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a psychological intervention involving education and simulated exposure, there may not be physical side effects like with medication; however, participants might experience emotional discomfort or increased anxiety during the process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-8 weeks post-delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-8 weeks post-delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-8 weeks post-delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability: questionnaire

Anxiety

Demand

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment1 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 InterventionExperimental Treatment1 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.

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