AnxietyNCT02303691
Attention Bias Modification for Transdiagnostic Anxiety
A study testing Attention Bias Modification and Neutral Training in people with Anxiety and Anxiety Disorders, run by University of Pittsburgh at 1 site in United States.
Trial summary
This project seeks to identify neural mechanisms underlying the tendency for anxious individuals to pay more attention to threatening information than to other types of information. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anxiety, Anxiety Disorders
- What is being tested?
- Attention Bias Modification and Neutral Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2018
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will:
- be between the ages of 18 and 55 years,
- score >45 on the Spielberger State-Trait Anxiety Inventory-trait form.
- score >=75th percentile on the World Health Organization Disability Assessment Schedule 2.0
Who cannot join
- Current medication or Cognitive-Behavioral Therapy for anxiety or depression;
- Failure to meet standard Magnetic Resonance Imaging (MRI) inclusion criteria: those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, Intrauterine Devices, metal braces, or other metal objects in their body, especially in the eye. If the subject has any metal or implants in the body they must be deemed safe by the MRI Research Center's safety screening procedure prior to enrollment. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on females.
- currently suicidal or at risk for harm to self or others,
- visual disturbance (<20/40 as per the Snellen test, corrective lenses allowed)
- <6th grade reading level as per the Wide Range Achievement Test
- presence of bipolar, psychotic, autism spectrum, substance dependence, or primary depressive disorder
- positive urine drug test
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Department of Psychiatry
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Neural Dimensions of Attention Bias Modification for Transdiagnostic Anxiety
This project seeks to identify neural mechanisms underlying the tendency for anxious individuals to pay more attention to threatening information than to other types of information. A computerized treatment designed to train individuals to reduce their attention towards threat will be tested, with a focus on understanding the aspects of brain function that predict response to the treatment. This work could ultimately lead to the ability to treat anxiety more effectively by directly targeting the aspects of brain function that are altered in a given patient.
- Conditions
- Anxiety, Anxiety Disorders
- Being tested
- Attention Bias Modification, Neutral Training
- Keywords
- anxiety, attention bias modification, computer
- 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 ModificationBehavioural
Excessive attention to threat is theorized to be a critical contributor to chronic anxiety symptoms and related negative health consequences. Attention Bias Modification, which directly targets this mechanism, is a highly cost-effective intervention with growing empirical support for its potential efficacy in clinically anxious populations.
Neutral TrainingBehavioural
A control version of computerized attention training.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Attention Bias Modification | Experimental | Not described Receives: Behavioral: Attention Bias Modification |
| Computerized Neutral Training | Sham comparator | Not described Receives: Behavioral: Neutral Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS--Hypervigilance item
Measured: 1 month
Secondary outcomes (8)
Mood and Anxiety Symptoms Questionnaire
Measured: 1 month
Mini International Neuropsychiatric Interview (MINI)
Measured: 1 month
Attentional bias towards threat (Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking)
Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking
Measured: immediate
Penn State Worry Questionnaire
Measured: 1 month
Liebowitz Social Anxiety Scale
Measured: 1 month
World Health Organization Disability Assessment Scale (WHODAS)
Measured: 1 month
Speilberger State-Trait Anxiety Inventory
Measured: 1 month
Beck Anxiety Inventory
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionJan 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Model description
- Completer analyses focused on prediction of active ABM outcomes using neural measures. Control arm used for effect size comparisons.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rebecca Price, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303691
- Sponsor's protocol ID
- 5K23MH100259
- Status last verified
- Mar 2018
- First submitted
- 25 Nov 2014
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Price RB, Cummings L, Gilchrist D, Graur S, Banihashemi L, Kuo SS, Siegle GJ. Towards personalized, brain-based behavioral intervention for transdiagnostic anxiety: Transient neural responses to negative images predict outcomes following a targeted computer-based intervention. J Consult Clin Psychol. 2018 Dec;86(12):1031-1045. doi: 10.1037/ccp0000309.
PubMed 30507228Price RB, Brown V, Siegle GJ. Computational Modeling Applied to the Dot-Probe Task Yields Improved Reliability and Mechanistic Insights. Biol Psychiatry. 2019 Apr 1;85(7):606-612. doi: 10.1016/j.biopsych.2018.09.022. Epub 2018 Oct 5.
PubMed 30449531
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Dimensions of Attention Bias Modification for Transdiagnostic Anxiety
- ClinicalTrials.gov ID
- NCT02303691
- Acronym / sponsor ID
- 5K23MH100259
- Conditions
- Anxiety, Anxiety Disorders
- Keywords
- anxiety, attention bias modification, computer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 1 Dec 2014 (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.
This project seeks to identify neural mechanisms underlying the tendency for anxious individuals to pay more attention to threatening information than to other types of information. A computerized treatment designed to train individuals to reduce their attention towards threat will be tested, with a focus on understanding the aspects of brain function that predict response to the treatment. This work could ultimately lead to the ability to treat anxiety more effectively by directly targeting the aspects of brain function that are altered in a given patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Completer analyses focused on prediction of active ABM outcomes using neural measures. Control arm used for effect size comparisons.
| Arm | Type | Receives |
|---|---|---|
| Computerized Attention Bias Modification | Experimental | Behavioral: Attention Bias Modification |
| Computerized Neutral Training | Sham comparator | Behavioral: Neutral Training |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants will:
Key exclusion criteria (7 listed)
- Current medication or Cognitive-Behavioral Therapy for anxiety or depression;
- Failure to meet standard Magnetic Resonance Imaging (MRI) inclusion criteria: those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, Intrauterine Devices, metal braces, or other metal objects in their body, especially in the eye. If the subject has any metal or implants in the body they must be deemed safe by the MRI Research Center's safety screening procedure prior to enrollment. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on females.
- currently suicidal or at risk for harm to self or others,
- visual disturbance (<20/40 as per the Snellen test, corrective lenses allowed)
- <6th grade reading level as per the Wide Range Achievement Test
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 ModificationExcessive attention to threat is theorized to be a critical contributor to chronic anxiety symptoms and related negative health consequences. Attention Bias Modification, which directly targets this mechanism, is a highly cost-effective intervention with growing empirical support for its potential efficacy in clinically anxious populations. | Behavioural | Computerized Attention Bias Modification |
| Neutral TrainingA control version of computerized attention training. | Behavioural | Computerized Neutral Training |
Primary outcome
CAPS--Hypervigilance item
Time frame: 1 month
8 secondary outcomes
Mood and Anxiety Symptoms Questionnaire
Time frame: 1 month
Mini International Neuropsychiatric Interview (MINI)
Time frame: 1 month
Attentional bias towards threat (Performance-based assessment of attentional bias towards threat based on reaction times and eye tracking)
Time frame: immediate
Penn State Worry Questionnaire
Time frame: 1 month
Liebowitz Social Anxiety Scale
Time frame: 1 month
World Health Organization Disability Assessment Scale (WHODAS)
Time frame: 1 month
Speilberger State-Trait Anxiety Inventory
Time frame: 1 month
Beck Anxiety Inventory
Time frame: 1 month
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 8 Mar 2018.
- Derived from this study: PubMed 30507228Price RB, Cummings L, Gilchrist D, Graur S, Banihashemi L, Kuo SS, Siegle GJ. Towards personalized, brain-based behavioral intervention for transdiagnostic anxiety: Transient neural responses to negative images predict outcomes following a targeted computer-based intervention. J Consult Clin Psychol. 2018 Dec;86(12):1031-1045. doi: 10.1037/ccp0000309.
- Derived from this study: PubMed 30449531Price RB, Brown V, Siegle GJ. Computational Modeling Applied to the Dot-Probe Task Yields Improved Reliability and Mechanistic Insights. Biol Psychiatry. 2019 Apr 1;85(7):606-612. doi: 10.1016/j.biopsych.2018.09.022. Epub 2018 Oct 5.
Related trials for Anxiety
Recruiting
Internet-Based EMDR Flash Intervention for Test Anxiety in University Students
Test Anxiety
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder: A Randomized Controlled Trial
Obsessive - Compulsive Disorder, Family Accommodation
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.
1 site 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 and Neutral Training in people with Anxiety and Anxiety Disorders, run by University of Pittsburgh at 1 site 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 4 inclusion and 7 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 8 Mar 2018. 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 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 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?
CAPS--Hypervigilance item (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303691, which also lists 2 linked publications.
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 8 Mar 2018.