Evaluation of Parturients With Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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CBM-I assignment

Patients will receive CBM-I assignments

Group Type EXPERIMENTAL

Cognitive Bias Modification for Interpretation (CBM-I)

Intervention Type BEHAVIORAL

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.

Placebo assignment

Patients will receive placebo assignments

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

Patients will receive placebo task which uses neutral rather than emotional material.

Interventions

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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.

Intervention Type BEHAVIORAL

Placebo

Patients will receive placebo task which uses neutral rather than emotional material.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes