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Clinical Trials/NCT04662463
NCT04662463WithdrawnNot Applicable

Evaluation of Parturients With Anxiety

Harvard Medical School (HMS and HSDM)0 sitesStarted: September 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Primary Endpoint
Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety

Time Frame: 4 weeks (starting from 36-week gestation)

Change in State-Trait Anxiety Inventory (STAI) scores before and after the CBM-I assignment.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Harvard Medical School (HMS and HSDM)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jie Zhou

Assistant Professor

Harvard Medical School (HMS and HSDM)

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