Evaluation of Parturients With Anxiety
Primary Purpose
Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Bias Modification for Interpretation (CBM-I)
Placebo
Sponsored by
About this trial
This is an interventional health services research trial for Anxiety
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CBM-I assignment
Placebo assignment
Arm Description
Patients will receive CBM-I assignments
Patients will receive placebo assignments
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04662463
First Posted
July 31, 2018
Last Updated
February 25, 2023
Sponsor
Harvard Medical School (HMS and HSDM)
1. Study Identification
Unique Protocol Identification Number
NCT04662463
Brief Title
Evaluation of Parturients With Anxiety
Official Title
Evaluation of Parturients With Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2024 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBM-I assignment
Arm Type
Experimental
Arm Description
Patients will receive CBM-I assignments
Arm Title
Placebo assignment
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo assignments
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Bias Modification for Interpretation (CBM-I)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo task which uses neutral rather than emotional material.
Primary Outcome Measure Information:
Title
Effects of Internet-Based Cognitive Bias Modification (CBM-I) on prenatal anxiety
Description
Change in State-Trait Anxiety Inventory (STAI) scores before and after the CBM-I assignment.
Time Frame
4 weeks (starting from 36-week gestation)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Parturients only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Zhou, MD, MS, MBA
Phone
617-732-8220
Email
jzhou@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Zhou, MD, MS, MBA
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22023278
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.
Results Reference
background
PubMed Identifier
22963595
Citation
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.
Results Reference
result
PubMed Identifier
16084841
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.
Results Reference
result
Learn more about this trial
Evaluation of Parturients With Anxiety
We'll reach out to this number within 24 hrs