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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 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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,050 Total Patients Enrolled
Allison Dempsey, PhDPrincipal InvestigatorChildren's Hospital Colorado
~0 spots leftby Jan 2025