- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03546946
Investigating Attention Patterns in Young People With Anxiety (ATTN-ANX)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Lau
- Phone Number: +44 20 7848 0678
- Email: jennifer.lau@kcl.ac.uk
Study Contact Backup
- Name: Stephen Lisk
- Phone Number: +44 20 7848 0978
- Email: stephen.lisk@kcl.ac.uk
Study Locations
-
-
England
-
London, England, United Kingdom, SE58AF
- Recruiting
- King's College London
-
Contact:
- Jennifer Lau
- Email: jennifer.lau@kcl.ac.uk
-
Contact:
- Stephen Lisk
- Email: stephen.lisk@kcl.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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