Evaluation of Parturients With Anxiety
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- Withdrawn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
Jie Zhou
Assistant Professor
Harvard Medical School (HMS and HSDM)