Generalized Anxiety DisorderABMTNCT01979263
Attention Bias Modification Treatment for Anxious Youth
A study testing Attention Bias Modification Computer Task in people with Generalized Anxiety Disorder and Separation Anxiety Disorder, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
The purpose of this project is to study the feasibility and efficacy of attention bias modification treatment (ABMT) in a randomized-controlled sample of anxious youth. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia
- What is being tested?
- Attention Bias Modification Computer Task
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to 17 Jan 2017
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis on Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual-IV Child and Parent versions of Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, or Generalized Anxiety Disorder
- Age 7 to 17
Who cannot join
- Posttraumatic stress disorder or primary diagnosis of major depressive disorder
- Seizure disorder
- Current treatment with psychotropic medication
- Multiple chronic learning disabilities and/or conduct problems
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Payne Whitney Manhattan Child Division
New York, New York, 10065
New York Presbyterian Hospital--Westchester Division
White Plains, New York, 10605
About this study
The purpose of this project is to study the feasibility and efficacy of attention bias modification treatment (ABMT) in a randomized-controlled sample of anxious youth.
Read the detailed description
The purpose of this study is to determine whether or not ABMT computer-based interventions can be used successfully to help reduce anxiety disorder symptoms in children ages 7 to 17. ABMT is different from most other treatments for anxiety because it is not medication or talk therapy. ABMT is a computerized attention training program designed to change how we direct our attention. The purpose of ABMT is to set in place attentional patterns that do not lead to excessive anxiety. Research has shown that it may be highly effective in reducing anxiety. The Intervention will be composed of your child engaging in 6 brief weekly ABMT sessions. The sessions seem like a repetitive computer game.
This study is appropriate for children who may have symptoms of an anxiety disorder, like Generalized Anxiety Disorder, Separation anxiety Disorder, Social Anxiety Disorder, Specific Phobia, or Obsessive-Compulsive Disorder." Children who appear eligible for the study may attend a diagnostic evaluation and assessment if they meet study criteria.
If a child is eligible for the study, he or she will be randomly assigned to either get an "active" form of the computer program or a "placebo" or inactive form of the computer program. The child will come to six weekly appointments at our clinic that are quite brief, about a half hour. Then the child will have an evaluation after the last of the six appointments to see if the computer intervention was helpful in reducing his or her anxiety. We'd then wait a month and then have a final evaluation to see if the child's anxiety has changed over that period of time.
- Conditions
- Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder
- Being tested
- Attention Bias Modification Computer Task, Placebo Computer Task
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety, Separation, Phobia, Social, Phobia, Specific, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias Modification Computer TaskOther
Computer task aimed at actively modifying attention bias
Placebo Computer TaskOther
Computer task that does not actively modify attention bias
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification | Active comparator | Attention Bias Modification computer task Receives: Other: Attention Bias Modification Computer Task |
| Placebo Computer Task | Placebo comparator | Placebo computer task Receives: Other: Placebo Computer Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version
Measured: after a 6-week intervention and 4-week no-treatment follow-up
Secondary outcomes (1)
Variation in genes associated with treatment response
We will study allelic variation in a gene that has been associated with treatment response to anxiety interventions, the serotonin-transporter-linked promoter region (5-HTTLPR)
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Why it stopped: Insufficient recruitment/data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan H Feltenberger, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979263
- Sponsor's protocol ID
- 1207012686R001-IRB
- Acronym
- ABMT
- Status last verified
- Jul 2019
- First submitted
- 30 Sep 2013
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Bias Modification Treatment for Anxious Youth
- ClinicalTrials.gov ID
- NCT01979263
- Acronym / sponsor ID
- ABMT / 1207012686R001-IRB
- Conditions
- Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment/data collection
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 8 Nov 2013 (estimated)
- 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.
The purpose of this project is to study the feasibility and efficacy of attention bias modification treatment (ABMT) in a randomized-controlled sample of anxious youth.
Detailed description
The purpose of this study is to determine whether or not ABMT computer-based interventions can be used successfully to help reduce anxiety disorder symptoms in children ages 7 to 17. ABMT is different from most other treatments for anxiety because it is not medication or talk therapy. ABMT is a computerized attention training program designed to change how we direct our attention. The purpose of ABMT is to set in place attentional patterns that do not lead to excessive anxiety. Research has shown that it may be highly effective in reducing anxiety. The Intervention will be composed of your child engaging in 6 brief weekly ABMT sessions. The sessions seem like a repetitive computer game.
This study is appropriate for children who may have symptoms of an anxiety disorder, like Generalized Anxiety Disorder, Separation anxiety Disorder, Social Anxiety Disorder, Specific Phobia, or Obsessive-Compulsive Disorder." Children who appear eligible for the study may attend a diagnostic evaluation and assessment if they meet study criteria.
If a child is eligible for the study, he or she will be randomly assigned to either get an "active" form of the computer program or a "placebo" or inactive form of the computer program. The child will come to six weekly appointments at our clinic that are quite brief, about a half hour. Then the child will have an evaluation after the last of the six appointments to see if the computer intervention was helpful in reducing his or her anxiety. We'd then wait a month and then have a final evaluation to see if the child's anxiety has changed over that period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification | Active comparator | Other: Attention Bias Modification Computer TaskAttention Bias Modification computer task |
| Placebo Computer Task | Placebo comparator | Other: Placebo Computer TaskPlacebo computer task |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis on Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual-IV Child and Parent versions of Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, or Generalized Anxiety Disorder
- Age 7 to 17
Key exclusion criteria (4 listed)
- Posttraumatic stress disorder or primary diagnosis of major depressive disorder
- Seizure disorder
- Current treatment with psychotropic medication
- Multiple chronic learning disabilities and/or conduct problems
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 Modification Computer TaskComputer task aimed at actively modifying attention bias | Other | Attention Bias Modification |
| Placebo Computer TaskComputer task that does not actively modify attention bias | Other | Placebo Computer Task |
Primary outcome
Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version
Time frame: after a 6-week intervention and 4-week no-treatment follow-up
1 secondary outcome
Variation in genes associated with treatment response
Time frame: week 1
Results and safety
The study was stopped early (reason given: Insufficient recruitment/data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: Yes
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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.
Megan H Feltenberger, PhD principal investigator
Weill Medical College of Cornell University
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 Computer Task in people with Generalized Anxiety Disorder and Separation Anxiety Disorder, run by Weill Medical College of Cornell 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 30 Jul 2019. 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. 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?
The study was stopped early (reason given: Insufficient recruitment/data collection). Results are not available in the source record.
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 clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version (time frame: after a 6-week intervention and 4-week no-treatment 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 30 Jul 2019.