Evaluation of Parturients With Anxiety

Sponsor

Harvard Medical School (HMS and HSDM) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04662463

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: Cognitive Bias Modification for Interpretation (CBM-I) Behavioral: Placebo	N/A

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

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

Evaluation of Parturients With Anxiety

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Harvard Medical School (HMS and HSDM)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Jie Zhou, Assistant Professor, Harvard Medical School (HMS and HSDM)

ClinicalTrials.gov Identifier:

NCT04662463

Other Study ID Numbers:

2017P000696

First Posted:

Dec 10, 2020

Last Update Posted:

Nov 24, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Nov 24, 2021