ATTN-ANX: Investigating Attention Patterns in Young People With Anxiety

Sponsor

King's College London (Other)

Overall Status

Unknown status

CT.gov ID

NCT03546946

Collaborator

South London and Maudsley NHS Foundation Trust (Other)

Enrollment

Location

Arms

18.9

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Adolescent Behavior	Behavioral: Gaze-Contingent Music Reward Training Behavioral: Control Training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Investigating Attention Patterns in Young People With Anxiety

Actual Study Start Date :

Jun 5, 2018

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jan 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in anxiety symtoms [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

Secondary Outcome Measures

Change in Self-report Anxiety [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.
Change in Dwell time on negative faces [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King's College London	London	England	United Kingdom	SE58AF

Sponsors and Collaborators

King's College London
South London and Maudsley NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

King's College London

ClinicalTrials.gov Identifier:

NCT03546946

Other Study ID Numbers:

225926

First Posted:

Jun 6, 2018

Last Update Posted:

Mar 25, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by King's College London

Attention

Anxiety

Adolescence

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Mar 25, 2019