AnxietyATTN-ANXNCT03546946
Investigating Attention Patterns in Young People With Anxiety
A study testing Gaze-Contingent Music Reward Training in people with Anxiety and Adolescent Behavior, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anxiety, Adolescent Behavior
- What is being tested?
- Gaze-Contingent Music Reward Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jun 2018to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-18 years of age upon study commencement
- Diagnosed generalised or social anxiety disorder (assessed by SCID)
- Informed written and witnessed consent
Who cannot join
- Psychosis
- Autism
- Learning difficulties
- Uncorrected abnormal vision
- Current use of SSRIs
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, England, SE58AF
Jennifer Lau, jennifer.lau@kcl.ac.uk
Stephen Lisk, stephen.lisk@kcl.ac.uk
About this study
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.
- Conditions
- Anxiety, Adolescent Behavior
- Being tested
- Gaze-Contingent Music Reward Training, Control Training
- Keywords
- Attention, Anxiety, Adolescence
- Medical subject headings
- Anxiety Disorders, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze-Contingent Music Reward TrainingBehavioural
Participants will hear their selected music track playing, dependent on their gaze location, when viewing a grid on neutral and negative faces.
Control TrainingBehavioural
Participants will hear their selected music track playing, regardless of their gaze location, when viewing a grid on neutral and negative faces.
| Study group | Role | What they receive |
|---|---|---|
| Gaze-Contingent Music Reward Training | Experimental | GCMRT for eight 20-minute sessions - twice per week over 4 weeks. Receives: 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. Receives: Behavioral: Control Training |
| No-Train Group | No intervention | No active training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and post-intervention (4 weeks), and at 3-month follow up.
Secondary outcomes (2)
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.
Measured: Baseline and post-intervention (4 weeks), 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.
Measured: Baseline and post-intervention (4 weeks), and at 3-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start5 Jun 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546946
- Sponsor's protocol ID
- 225926
- Acronym
- ATTN-ANX
- Status last verified
- Mar 2019
- First submitted
- 20 Oct 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Attention Patterns in Young People With Anxiety
- ClinicalTrials.gov ID
- NCT03546946
- Acronym / sponsor ID
- ATTN-ANX / 225926
- Conditions
- Anxiety, Adolescent Behavior
- Keywords
- Attention, Anxiety, Adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gaze-Contingent Music Reward Training | Experimental | Behavioral: Gaze-Contingent Music Reward TrainingGCMRT for eight 20-minute sessions - twice per week over 4 weeks. |
| Control Training | Placebo comparator | Behavioral: Control TrainingPassive viewing task with continuous music for eight 20-minute sessions - twice per week over 4 weeks. |
| No-Train Group | No intervention | –No active training. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 12-18 years of age upon study commencement
- Diagnosed generalised or social anxiety disorder (assessed by SCID)
- Informed written and witnessed consent
Key exclusion criteria (5 listed)
- Psychosis
- Autism
- Learning difficulties
- Uncorrected abnormal vision
- Current use of SSRIs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaze-Contingent Music Reward TrainingParticipants will hear their selected music track playing, dependent on their gaze location, when viewing a grid on neutral and negative faces. | Behavioural | Gaze-Contingent Music Reward Training |
| Control TrainingParticipants will hear their selected music track playing, regardless of their gaze location, when viewing a grid on neutral and negative faces. | Behavioural | Control Training |
Primary outcome
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
2 secondary outcomes
Change in Self-report Anxiety
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaze-Contingent Music Reward Training in people with Anxiety and Adolescent Behavior, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Lau (+44 20 7848 0678, jennifer.lau@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety symtoms (time frame: Baseline and post-intervention (4 weeks), and at 3-month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.