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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a single session of cognitive-behavioral therapy, specifically an exposure intervention, can reduce anxiety before and after a C-section in high-risk pregnancies. Participants will learn about the procedure and experience a simulated walk-through to alleviate their concerns. The trial will also assess participant satisfaction with this approach. Women planning a C-section due to pregnancy complications may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance anxiety management for future patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cognitive-behavioral intervention is safe for reducing anxiety in high-risk pregnancies?

Research has shown that exposure-based cognitive behavioral therapy (CBT) is safe for pregnant women with anxiety. This therapy involves gradually facing fears in a controlled environment and is well-tolerated. No negative effects from the treatment have been reported. In fact, women who participated in these sessions felt less anxious after just two weeks. This suggests that exposure-based CBT could be a safe and effective way to manage anxiety during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cognitive behavioral therapy (CBT) for procedural anxiety in high-risk pregnancies because it offers a new way to manage anxiety through exposure intervention. Unlike standard care, which typically involves meeting with an anesthesiologist to discuss techniques, CBT actively engages patients in psychoeducation and behavioral exposure to the Cesarean section process. This hands-on approach can help desensitize patients to the procedure, potentially reducing anxiety more effectively than traditional methods that focus on information alone. By addressing procedural anxiety directly, this intervention could make the delivery experience less stressful and more manageable for expectant mothers.

What evidence suggests that this exposure intervention is effective for reducing procedural anxiety in high-risk pregnancies?

Research has shown that cognitive-behavioral therapy (CBT), particularly with exposure-based techniques, can effectively reduce anxiety. In this trial, participants in the Exposure Intervention arm will receive CBT with exposure exercises specifically designed to manage anxiety related to Cesarean deliveries. One study found that women who received this therapy experienced a significant drop in their anxiety levels, as measured by the GAD-7 scale, just two weeks after treatment. This decrease was much greater compared to those who received a different type of therapy. These findings suggest that CBT with exposure exercises is a promising method for reducing anxiety in pregnant women facing surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Allison Dempsey, PhD

Principal Investigator

Children's Hospital Colorado

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04203082

Cognitive Behavioral Intervention to Reduce Procedural ... The goals of this study are to determine the feasibility and efficacy of a brief, single-session cognitive-behavioral intervention for reducing preoperative ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S016503272301251X

Exposure-based cognitive-behaviour therapy for anxiety ... Women receiving INT-CBT showed a reduction in anxiety (GAD-7) after two weeks of treatment compared to WCBT (aMD = −4.17, 95%CI −6.03 to −2.31) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37848088/

Exposure-based cognitive-behaviour therapy for anxiety ... Women receiving INT-CBT showed a reduction in anxiety (GAD-7) after two weeks of treatment compared to WCBT (aMD = -4.17, 95%CI -6.03 to -2.31) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10052839/

Effectiveness of cognitive behavioural therapy-based ... CBT-based interventions for depression during the perinatal period appear effective, however results should be interpreted with caution.

5. nature.com nature.com/articles/s41598-024-64119-z

Results of a cognitive behavior therapy-based intervention ... We conducted a randomized controlled trial to evaluate the effects of the Happy Mother-Healthy Baby program, designed to reduce anxiety during pregnancy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7200036/

Cognitive–behavioral therapy-based intervention to treat ... This trial assesses an intervention initiated in early pregnancy to mid pregnancy among women with clinical or subclinical symptoms of anxiety in Pakistan.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796713001940

Cognitive behavioral therapy and pharmacotherapy for ... Conclusions. Non-pregnant and especially pregnant women rated exposure-based CBT for anxiety more favorably than pharmacotherapy. Pregnancy status predicted ...