Evaluation of Parturients With Anxiety

Harvard Medical School (HMS and HSDM)

Status: Withdrawn

Conditions: Anxiety

Treatments: Behavioral: Cognitive Bias Modification for Interpretation (CBM-I); Behavioral: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04662463

2017P000696

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

CBM-I assignment

Experimental group

Description:

Patients will receive CBM-I assignments

Treatment:

Behavioral: Cognitive Bias Modification for Interpretation (CBM-I)

Placebo assignment

Placebo Comparator group

Description:

Patients will receive placebo assignments

Treatment:

Behavioral: Placebo