Evaluation of Parturients With Anxiety

Not Applicable

Withdrawn

• Conditions: Anxiety
• Interventions: Behavioral: Cognitive Bias Modification for Interpretation (CBM-I); Behavioral: Placebo

• Registration Number: NCT04662463
• Lead Sponsor: Harvard Medical School (HMS and HSDM)

Brief 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.

Study Timeline

• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Study Start: 2024-09
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18-45
• Women before 36-week gestation
• At least high school level education

Exclusion Criteria

• They refuse
• Have impaired decision-making capacity
• Are blind or extremely visually impaired (excluding use of glasses)
• Cannot understand or read English
• Diagnosed with psychiatric disorder other than anxiety

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBM-I assignment	Cognitive Bias Modification for Interpretation (CBM-I)	Patients will receive CBM-I assignments
Placebo assignment	Placebo	Patients will receive placebo assignments

Primary Outcome Measures

Name	Time	Method
Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety	4 weeks (starting from 36-week gestation)	Change in State-Trait Anxiety Inventory (STAI) scores before and after the CBM-I assignment.