AnxietyNCT03176004
Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
A study testing Attention Bias Modification in people with Anxiety, run by Florida State University at 2 sites in United States.
Trial summary
This is a multi-site study to examine error-related brain activity (i.e., the error-related negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated by two years. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Attention Bias Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to 1 Dec 2021
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children and parent must speak English well enough to complete the study assessments
Who cannot join
- current threat of harm to self or others, bipolar illness, psychosis, thought disorder, pervasive developmental disorder, mental retardation, neurological diseases that impair cognition, or significant head injuries (past 3 months).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Diego State University
San Diego, California, 92120
Florida State University
Tallahassee, Florida, 32306
About this study
This is a multi-site study to examine error-related brain activity (i.e., the error-related negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated by two years. The study examines the degree to which error-related negativity can predict anxiety prospectively over two years, and whether a computerized game that alters attention to threat can alter error-related negativity and trajectories of anxiety.
Read the detailed description
Approximately 600 youths between the ages of 11 and 14 and their parents will be assessed. Adolescents will be evaluated at baseline using event-related potentials, self-report, and interview-based measures. The error-related negativity will be evaluated immediately (it takes less than 5 minutes to process and score a single subjects' error-related negativity ), and adolescents with good error-related negativity data (~90%, based on scorable error-related negativity data) will be randomly assigned to either an 8-week (i.e., 16 session) adaptive attention bias modification (N=180) or control condition (N=180) or a waitlist condition (N=180) group. Each session lasts 20 minutes, and participants will be asked to complete two 20-minute sessions per week. Participants will be assessed immediately at post, using the same measures from the baseline assessment. All participants will complete a 2-year follow-up lab visit using the same measures from the baseline assessment.
- Conditions
- Anxiety
- Being tested
- Attention Bias Modification
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias ModificationOther
A computer game is used to facilitate attention away from threatening words.
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification | Experimental | Participants play a game in which they can move up in levels by reducing their reaction time to targets presented in the location of a threatening word. Receives: Other: Attention Bias Modification |
| Active Control Condition | Active comparator | Participants play a game in which they can move up in levels by reducing their reaction time to targets presented in the location of a word with a specific color. Receives: Other: Attention Bias Modification |
| Wait List | No intervention | Participants simply return after 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Symptoms
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Measured: Baseline to 8 week
Change in Anxiety Symptoms
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Measured: baseline to 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startOct 2016
- Primary completion1 Jan 2020
- Study completion1 Dec 2021
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 Florida State UniversityThe 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
- Parallel groups
- Model description
- Adolescents are randomized to either a game that trains attention away from threat (attention bias modification), a game that trains attention but unrelated to threat (control condition), or a wait list group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Greg Hajcak, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176004
- Sponsor's protocol ID
- MH106477
- Status last verified
- Dec 2021
- First submitted
- 31 May 2017
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is being uploaded to the Research Domain Criteria Database, and will be available through National Institute of Mental Health Data Archive; the analyzed data yielded in our project, as specified in the same document (i.e., 12 months after accomplishment of each primary aim or objective, or immediately upon publication of the project's primary results, whichever occurs first).
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
- ClinicalTrials.gov ID
- NCT03176004
- Acronym / sponsor ID
- MH106477
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- Oct 2016 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Jun 2017 (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.
This is a multi-site study to examine error-related brain activity (i.e., the error-related negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated by two years. The study examines the degree to which error-related negativity can predict anxiety prospectively over two years, and whether a computerized game that alters attention to threat can alter error-related negativity and trajectories of anxiety.
Detailed description
Approximately 600 youths between the ages of 11 and 14 and their parents will be assessed. Adolescents will be evaluated at baseline using event-related potentials, self-report, and interview-based measures. The error-related negativity will be evaluated immediately (it takes less than 5 minutes to process and score a single subjects' error-related negativity ), and adolescents with good error-related negativity data (~90%, based on scorable error-related negativity data) will be randomly assigned to either an 8-week (i.e., 16 session) adaptive attention bias modification (N=180) or control condition (N=180) or a waitlist condition (N=180) group. Each session lasts 20 minutes, and participants will be asked to complete two 20-minute sessions per week. Participants will be assessed immediately at post, using the same measures from the baseline assessment. All participants will complete a 2-year follow-up lab visit using the same measures from the baseline assessment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Adolescents are randomized to either a game that trains attention away from threat (attention bias modification), a game that trains attention but unrelated to threat (control condition), or a wait list group.
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification | Experimental | Other: Attention Bias ModificationParticipants play a game in which they can move up in levels by reducing their reaction time to targets presented in the location of a threatening word. |
| Active Control Condition | Active comparator | Other: Attention Bias ModificationParticipants play a game in which they can move up in levels by reducing their reaction time to targets presented in the location of a word with a specific color. |
| Wait List | No intervention | –Participants simply return after 8 weeks. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children and parent must speak English well enough to complete the study assessments
Key exclusion criteria (1 listed)
- current threat of harm to self or others, bipolar illness, psychosis, thought disorder, pervasive developmental disorder, mental retardation, neurological diseases that impair cognition, or significant head injuries (past 3 months).
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 |
|---|---|---|
| Attention Bias ModificationA computer game is used to facilitate attention away from threatening words. | Other | Active Control Condition, Attention Bias Modification |
Primary outcome
Change in Anxiety Symptoms
Time frame: Baseline to 8 week
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Change in Anxiety Symptoms
Time frame: baseline to 2 year follow-up
Symptoms of Anxiety on the Screen for Child Anxiety Related Emotional Disorders (SCARED)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: Yes. Data is being uploaded to the Research Domain Criteria Database, and will be available through National Institute of Mental Health Data Archive; the analyzed data yielded in our project, as specified in the same document (i.e., 12 months after accomplishment of each primary aim or objective, or immediately upon publication of the project's primary results, whichever occurs first).
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Modification in people with Anxiety, run by Florida State University at 2 sites in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Symptoms (time frame: Baseline to 8 week). The study lists 2 primary outcomes in all. 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 20 Dec 2021; AzTrials last refreshed its copy on 3 Nov 2026.