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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
Harvard Medical School (HMS and HSDM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    July 31, 2018
    Last Updated
    February 25, 2023
    Sponsor
    Harvard Medical School (HMS and HSDM)
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    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

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    Evaluation of Parturients With Anxiety

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