Evaluation of Parturients With Anxiety

Anxiety Clinical Trial

Official title:

Evaluation of Parturients With Anxiety

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04662463
• Other study ID #: 2017P000696
• Status: Withdrawn
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)

References & Publications (3)

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)