NCT03546946

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

June 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

October 20, 2017

Last Update Submit

March 22, 2019

Conditions

Keywords

AttentionAnxietyAdolescence

Outcome Measures

Primary Outcomes (1)

  • Change in anxiety symtoms

    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 Outcomes (2)

  • Change in Self-report Anxiety

    Baseline and post-intervention (4 weeks), and at 3-month follow up.

  • Change in Dwell time on negative faces

    Baseline and post-intervention (4 weeks), and at 3-month follow up.

Study Arms (3)

Gaze-Contingent Music Reward Training

EXPERIMENTAL

GCMRT for eight 20-minute sessions - twice per week over 4 weeks.

Behavioral: Gaze-Contingent Music Reward Training

Control Training

PLACEBO COMPARATOR

Passive viewing task with continuous music for eight 20-minute sessions - twice per week over 4 weeks.

Behavioral: Control Training

No-Train Group

NO INTERVENTION

No active training.

Interventions

Participants will hear their selected music track playing, dependent on their gaze location, when viewing a grid on neutral and negative faces.

Gaze-Contingent Music Reward Training

Participants will hear their selected music track playing, regardless of their gaze location, when viewing a grid on neutral and negative faces.

Control Training

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, England, SE58AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersAdolescent Behavior

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

June 6, 2018

Study Start

June 5, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations