NCT04662463

Evaluation of Parturients With Anxiety

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to examine the effects of cognitive bias modification for interpretation (CBM-I) on prenatal anxiety in parturients. Half of the participants will receive CBM-I assignments, while the other half will receive placebo assignments.

Detailed description

Maternal prenatal anxiety has been shown to have implications on neonatal behavior and early childhood behavioral and emotional wellbeing. Recent studies found that adults using computer-assisted feedback-learning paradigms, referred to as Cognitive Bias Modification for Interpretation (CBM-I), experienced significant reductions in levels of social anxiety, trait anxiety, and depression. Our goal is to identify patients with prenatal anxiety and evaluate the effects of CBM-I on symptoms of prenatal anxiety and patient satisfaction with the labor and delivery experience.

Conditions

• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Bias Modification for Interpretation (CBM-I)	Patients will receive CBM-I training by reading and imaging themselves in a series of emotionally ambiguous scenarios. Each scenario ends with an incomplete final word. Patients need to complete the final word to resolve the scenario in a positive direction.
BEHAVIORAL	Placebo	Patients will receive placebo task which uses neutral rather than emotional material.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2020-12-10
• Last updated: 2024-05-13