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Evaluation of Parturients With Anxiety

Evaluation of Parturients With Anxiety

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04662463
Enrollment
0
Registered
2020-12-10
Start date
2024-09-30
Completion date
2026-12-31
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

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.

Interventions

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.

BEHAVIORALPlacebo

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

Sponsors

Harvard Medical School (HMS and HSDM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety4 weeks (starting from 36-week gestation)Change in State-Trait Anxiety Inventory (STAI) scores before and after the CBM-I assignment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026