Evaluation of Parturients With Anxiety

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Cognitive Bias Modification for Interpretation (CBM-I); Behavioral: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Zhou, MD, MS, MBA; Phone Number: 617-732-8220; Email: jzhou@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBM-I assignment; Patients will receive CBM-I assignments	Behavioral: 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.
Placebo Comparator: Placebo assignment; Patients will receive placebo assignments	Behavioral: Placebo; Patients will receive placebo task which uses neutral rather than emotional material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety	Change in State-Trait Anxiety Inventory (STAI) scores before and after the CBM-I assignment.	4 weeks (starting from 36-week gestation)

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)
• Investigators: Principal Investigator: Jie Zhou, MD, MS, MBA, Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• Lester KJ, Field AP, Muris P. Experimental modification of interpretation bias about animal fear in young children: effects on cognition, avoidance behavior, anxiety vulnerability, and physiological responding. J Clin Child Adolesc Psychol. 2011;40(6):864-77. doi: 10.1080/15374416.2011.618449.
• Bowler JO, Mackintosh B, Dunn BD, Mathews A, Dalgleish T, Hoppitt L. A comparison of cognitive bias modification for interpretation and computerized cognitive behavior therapy: effects on anxiety, depression, attentional control, and interpretive bias. J Consult Clin Psychol. 2012 Dec;80(6):1021-33. doi: 10.1037/a0029932. Epub 2012 Sep 10.
• O'Connor TG, Ben-Shlomo Y, Heron J, Golding J, Adams D, Glover V. Prenatal anxiety predicts individual differences in cortisol in pre-adolescent children. Biol Psychiatry. 2005 Aug 1;58(3):211-7. doi: 10.1016/j.biopsych.2005.03.032.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2024
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 25, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2017P000696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No