Investigating Attention Patterns in Young People With Anxiety (ATTN-ANX)

March 22, 2019 updated by: King's College London

Adolescents with elevated anxiety have been found to direct their voluntary and involuntary attention more readily toward threatening stimuli, and spend more time dwelling upon that stimuli. Various computerised tasks have been developed to attempt to retrain these "attention biases" back away from threat.

This study will test a newly developed intervention, that uses (eye-tracking) methods to track the gaze of the individual. This intervention is called Gaze-Contingent Music Reward Training (GC-MRT), and is designed to re-train the individual away from dwelling upon threatening stimuli (emotional faces), using their favourite music to re-infornce this learning.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

99

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

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

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 12-18 years of age upon study commencement
  • Diagnosed generalised or social anxiety disorder (assessed by SCID)
  • Informed written and witnessed consent

Exclusion Criteria:

  • Psychosis
  • Autism
  • Learning difficulties
  • Uncorrected abnormal vision
  • Current use of SSRIs

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: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gaze-Contingent Music Reward Training
GCMRT for eight 20-minute sessions - twice per week over 4 weeks.
Behavioral: Gaze-Contingent Music Reward Training
Participants will hear their selected music track playing, dependent on their gaze location, when viewing a grid on neutral and negative faces.
PLACEBO_COMPARATOR: Control Training
Passive viewing task with continuous music for eight 20-minute sessions - twice per week over 4 weeks.
Behavioral: Control Training
Participants will hear their selected music track playing, regardless of their gaze location, when viewing a grid on neutral and negative faces.
NO_INTERVENTION: No-Train Group
No active training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety symtoms
Time Frame: Baseline and post-intervention (4 weeks), and at 3-month follow up.
Change in anxiety symptoms from baseline at 4-weeks on the Kiddie Schedule for Affective Disorders (KSADS), and at 3-month follow up
Baseline and post-intervention (4 weeks), and at 3-month follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-report Anxiety
Time Frame: Baseline and post-intervention (4 weeks), and at 3-month follow up.
Change in self-report anxiety symptoms from baseline at 4-weeks on the Screen for Child Anxiety Related Disorders (SCARED), and at 3-month follow up.
Baseline and post-intervention (4 weeks), and at 3-month follow up.
Change in Dwell time on negative faces
Time Frame: Baseline and post-intervention (4 weeks), and at 3-month follow up.
Change in dwell time on negative faces, from baseline at 4-weeks, using eye-tracking measures on a free-viewing attention task, and at 3-month follow up.
Baseline and post-intervention (4 weeks), and at 3-month follow up.

Collaborators and Investigators

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

Sponsor

King's College London

Collaborators

South London and Maudsley NHS Foundation Trust

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)

June 5, 2018

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

May 23, 2018

First Posted (ACTUAL)

June 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 22, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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