Investigating Attention Patterns in Young People With Anxiety (ATTN-ANX)
Primary Purpose
Anxiety, Adolescent Behavior
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Gaze-Contingent Music Reward Training
Control Training
Sponsored by
About this trial
This is an interventional basic science trial for Anxiety focused on measuring Attention, Anxiety, Adolescence
Eligibility Criteria
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
Sites / Locations
- King's College LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Gaze-Contingent Music Reward Training
Control Training
No-Train Group
Arm Description
GCMRT for eight 20-minute sessions - twice per week over 4 weeks.
Passive viewing task with continuous music for eight 20-minute sessions - twice per week over 4 weeks.
No active training.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in Self-report Anxiety
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
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.
Full Information
NCT ID
NCT03546946
First Posted
October 20, 2017
Last Updated
March 22, 2019
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03546946
Brief Title
Investigating Attention Patterns in Young People With Anxiety
Acronym
ATTN-ANX
Official Title
Investigating Attention Patterns in Young People With Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Adolescent Behavior
Keywords
Attention, Anxiety, Adolescence
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gaze-Contingent Music Reward Training
Arm Type
Experimental
Arm Description
GCMRT for eight 20-minute sessions - twice per week over 4 weeks.
Arm Title
Control Training
Arm Type
Placebo Comparator
Arm Description
Passive viewing task with continuous music for eight 20-minute sessions - twice per week over 4 weeks.
Arm Title
No-Train Group
Arm Type
No Intervention
Arm Description
No active training.
Intervention Type
Behavioral
Intervention Name(s)
Gaze-Contingent Music Reward Training
Intervention Description
Participants will hear their selected music track playing, dependent on their gaze location, when viewing a grid on neutral and negative faces.
Intervention Type
Behavioral
Intervention Name(s)
Control Training
Intervention Description
Participants will hear their selected music track playing, regardless of their gaze location, when viewing a grid on neutral and negative faces.
Primary Outcome Measure Information:
Title
Change in anxiety symtoms
Description
Change in anxiety symptoms from baseline at 4-weeks on the Kiddie Schedule for Affective Disorders (KSADS), and at 3-month follow up
Time Frame
Baseline and post-intervention (4 weeks), and at 3-month follow up.
Secondary Outcome Measure Information:
Title
Change in Self-report Anxiety
Description
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.
Time Frame
Baseline and post-intervention (4 weeks), and at 3-month follow up.
Title
Change in Dwell time on negative faces
Description
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.
Time Frame
Baseline and post-intervention (4 weeks), and at 3-month follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Lau
Phone
+44 20 7848 0678
Email
jennifer.lau@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Lisk
Phone
+44 20 7848 0978
Email
stephen.lisk@kcl.ac.uk
Facility Information:
Facility Name
King's College London
City
London
State/Province
England
ZIP/Postal Code
SE58AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Lau
Email
jennifer.lau@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Stephen Lisk
Email
stephen.lisk@kcl.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigating Attention Patterns in Young People With Anxiety
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