Evaluation of Parturients With Anxiety

NCT04662463 | Withdrawn

• 1 other identifier: 2017P000696
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

CBM-I assignment

EXPERIMENTAL

Patients will receive CBM-I assignments

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

Placebo assignment

PLACEBO COMPARATOR

Patients will receive placebo assignments

Behavioral: Placebo

Interventions

Cognitive Bias Modification for Interpretation (CBM-I) BEHAVIORAL

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.

CBM-I assignment

Placebo BEHAVIORAL

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

Placebo assignment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Parturients only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45
• Women before 36-week gestation
• At least high school level education

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead

Related Publications (3)

• 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.

  PMID: 22023278 BACKGROUND

• 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.

  PMID: 22963595 RESULT

• 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.

  PMID: 16084841 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jie Zhou, MD, MS, MBA

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: December 10, 2020
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share