Trait Anxiety and Defensive Networks

February 10, 2022 updated by: Keith Kendrick, University of Electronic Science and Technology of China

Trait Anxiety Modulates Resting State Functional Connectivity of Defensive Networks

to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals with high trait anxiety show stable anxiety proneness even in the absence of real threat, which could be a result of intrinsic hyper-connectivity in the defensive systems. In the present study, healthy subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory. Then two experiments using resting-state fMRI technique will be conducted to first map how hubs in the defensive systems organized in high anxious individuals in a stimuli-free situation (Experiment 1) and then we will examine the modulatory effect of the intranasal administration of oxytocin on functional connectivity in these independently defined defensive networks (Experiment 2).

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610054
        • School of Life Science and Technology, University of Electronic Science and Technology of China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

  • females should not be pregnant or during menstruation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: high trait anxiety group
experiment 1: identified according to scores of the trait anxiety scale.
Behavioral: trait anxiety scale
splitting subjects into 2 groups according to scores of the trait anxiety scale
EXPERIMENTAL: low trait anxiety group
experiment 1: identified according to scores of the trait anxiety scale.
Behavioral: trait anxiety scale
splitting subjects into 2 groups according to scores of the trait anxiety scale
EXPERIMENTAL: oxytocin group
experiment 2: intranasal administration of oxytocin
Drug: Oxytocin
intranasal administration of oxytocin
PLACEBO_COMPARATOR: placebo control group
experiment 2: intranasal administration of placebo
Drug: Placebo
intranasal administration of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the resting state functional connectivity changes in the defensive network
Time Frame: one day
The resting-state activity can be accessed using functional magnetic resonance imaging (fMRI) by measuring spontaneous and low-frequency fluctuations (< 0.1 Hz) when the brain is at rest. Group differences will be calculated in the high trait anxiety group relative to the low trait anxiety group and in the oxytocin group relative to the placebo group.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 8, 2015

Primary Completion (ACTUAL)

August 19, 2021

Study Completion (ACTUAL)

November 20, 2021

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (ESTIMATE)

February 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UESTC-neuSCAN_20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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