AnxietyNCT03092609
Neuroplasticity in an Extended Amygdala Network as a Target Mechanism for Attention Bias Modification Outcome
A study testing Attention Bias Modification in people with Anxiety, run by Northern Michigan University at 1 site in United States.
Trial summary
Anxiety disorders are one of the most common psychological disorders. Underlying anxiety is an increased attentional bias to threat, which has been identified as a causal contributor in the development of anxiety. Read more about this study
- Who is it for?
- Ages 18 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Attention Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 14 Mar 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 18 to 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Handedness (right handed)
- Normal Vision
- High Anxiety
- Preexisting Attentional Bias
Who cannot join
- No MRI contraindications
- No History of Head Injury
- No Neurological History
- Psychological History
- Limited Recreational Drug Use, No Abuse
- Limited Prescription Drug Use, No Abuse
- No Claustrophobia
- Not Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Michigan University
Marquette, Michigan, 49855
About this study
Anxiety disorders are one of the most common psychological disorders. Underlying anxiety is an increased attentional bias to threat, which has been identified as a causal contributor in the development of anxiety. Given this causal relationship, attention bias modification was introduced as a treatment option where anxiety is reduced by training individuals to direct their attention away from threat and thereby decreasing anxiety. Over a decade of research using this approach, called attention bias modification (ABM), suggests that overall the approach is effective in reducing anxiety. Although ABM appears to be a very promising treatment option for anxiety, there are several factors limiting the effectiveness of ABM. These include the recognition of individual-level needs and a known underlying mechanism of action by which ABM is effective. Neuroimaging evidence suggests that attentional bias to visual threat is associated with a network of brain regions including the amygdala, anterior cingulate cortex, and visual cortex. In human participants, experience-dependent neuroplasticity is visible in voxel-based morphometry based measures of gray matter volume following training. Recently, voxel-based morphometry measures of gray matter volume have been linked to dendritic spine density-a known cellular mechanism for learning-related neuroplasticity. Thus, voxel-based morphometry measures are ideally suited to measure learning-related neuroplasticity following attention bias modification. In this proposal participants' level of attentional bias, anxiety, and gray matter volume will be measured before and after completing six weeks of attention bias modification training (N = 50) or attention control training (N= 50). The proposal aims to (1) establish that pre-treatment bias predicts variability in gray matter volume in the extended amygdala and anterior cingulate cortex, (2) assess the extent to which reduced extended amygdala and anterior cingulate cortex gray matter volume following ABM underlies reductions in attentional bias and anxiety, and (3) Establish pre-treatment bias as a predictor of successful ABM as measured by reduced bias, reduced anxiety, and reduced gray matter volume in the extended amygdala and anterior cingulate cortex. Consistent with the objectives of the AREA grant and NIMH's focus on identifying and validating new targets for treatment development that underlie disease mechanisms, the current proposal plans to involve students at a rural primarily undergraduate university in a research project aimed at establishing neuroplasticity in the extended amygdala and anterior cingulate cortex as a target mechanism for ABM training outcome, which could be used to objectively track training-related outcomes in anxiety treatment.
- Conditions
- Anxiety
- Being tested
- Attention Bias Modification, Attention Control
- Keywords
- Attentional Bias to Threat
- 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
Attention bias modification (ABM) sessions will consist of a modified dot-probe task that only contains incongruent trials (i.e., target-dot - neutral stimulus 100% pairing).
Attention ControlBehavioural
Attention control (AC) sessions, will consist of a standard dot-probe task (i.e., target-dot - neutral/threat stimulus 50% pairing). Thus, for AC participants, bias should remain the same, while ABM participants should show a reduced bias to threat.
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification | Experimental | Not described Receives: Behavioral: Attention Bias Modification |
| Attention Control | Active comparator | Not described Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional Bias
Reaction time difference to congruent and incongruent trials in the dot-probe task, which measure heightened attentional bias to threat.
Measured: Baseline and after 6 weeks of the intervention
Secondary outcomes (1)
State and Trait Anxiety
Anxiety as measured by the Speilberger State-Trait Anxiety Inventory
Measured: Baseline and after 6 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start15 Dec 2017
- Primary completion14 Mar 2020
- Study completion14 Mar 2020
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Michigan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Joshua M Carlson, PhD, Principal investigator, Northern Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092609
- Sponsor's protocol ID
- HS13-555
- Other IDs
- R15MH110951
- Status last verified
- Jan 2022
- First submitted
- 14 Mar 2017
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded to the NIMH Data Archive
Publications
Carlson JM, Fang L, Koster EHW, Andrzejewski JA, Gilbertson H, Elwell KA, Zuidema TR. Neuroplastic changes in anterior cingulate cortex gray matter volume and functional connectivity following attention bias modification in high trait anxious individuals. Biol Psychol. 2022 Jul;172:108353. doi: 10.1016/j.biopsycho.2022.108353. Epub 2022 May 13.
PubMed 35569575Carlson JM, Fang L. Attentional bias to threat and gray matter volume morphology in high anxious individuals. Cogn Affect Behav Neurosci. 2022 Jun;22(3):600-609. doi: 10.3758/s13415-021-00968-9. Epub 2021 Nov 9.
PubMed 34755317
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity in an Extended Amygdala Network as a Target Mechanism for Attention Bias Modification Outcome
- ClinicalTrials.gov ID
- NCT03092609
- Acronym / sponsor ID
- HS13-555
- Conditions
- Anxiety
- Keywords
- Attentional Bias to Threat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Northern Michigan UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 28 Mar 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.
Anxiety disorders are one of the most common psychological disorders. Underlying anxiety is an increased attentional bias to threat, which has been identified as a causal contributor in the development of anxiety. Given this causal relationship, attention bias modification was introduced as a treatment option where anxiety is reduced by training individuals to direct their attention away from threat and thereby decreasing anxiety. Over a decade of research using this approach, called attention bias modification (ABM), suggests that overall the approach is effective in reducing anxiety. Although ABM appears to be a very promising treatment option for anxiety, there are several factors limiting the effectiveness of ABM. These include the recognition of individual-level needs and a known underlying mechanism of action by which ABM is effective. Neuroimaging evidence suggests that attentional bias to visual threat is associated with a network of brain regions including the amygdala, anterior cingulate cortex, and visual cortex. In human participants, experience-dependent neuroplasticity is visible in voxel-based morphometry based measures of gray matter volume following training. Recently, voxel-based morphometry measures of gray matter volume have been linked to dendritic spine density-a known cellular mechanism for learning-related neuroplasticity. Thus, voxel-based morphometry measures are ideally suited to measure learning-related neuroplasticity following attention bias modification. In this proposal participants' level of attentional bias, anxiety, and gray matter volume will be measured before and after completing six weeks of attention bias modification training (N = 50) or attention control training (N= 50). The proposal aims to (1) establish that pre-treatment bias predicts variability in gray matter volume in the extended amygdala and anterior cingulate cortex, (2) assess the extent to which reduced extended amygdala and anterior cingulate cortex gray matter volume following ABM underlies reductions in attentional bias and anxiety, and (3) Establish pre-treatment bias as a predictor of successful ABM as measured by reduced bias, reduced anxiety, and reduced gray matter volume in the extended amygdala and anterior cingulate cortex. Consistent with the objectives of the AREA grant and NIMH's focus on identifying and validating new targets for treatment development that underlie disease mechanisms, the current proposal plans to involve students at a rural primarily undergraduate university in a research project aimed at establishing neuroplasticity in the extended amygdala and anterior cingulate cortex as a target mechanism for ABM training outcome, which could be used to objectively track training-related outcomes in anxiety treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification | Experimental | Behavioral: Attention Bias Modification |
| Attention Control | Active comparator | Behavioral: Attention Control |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Handedness (right handed)
- Normal Vision
- High Anxiety
- Preexisting Attentional Bias
Key exclusion criteria (8 listed)
- No MRI contraindications
- No History of Head Injury
- No Neurological History
- Psychological History
- Limited Recreational Drug Use, No Abuse
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 ModificationAttention bias modification (ABM) sessions will consist of a modified dot-probe task that only contains incongruent trials (i.e., target-dot - neutral stimulus 100% pairing). | Behavioural | Attention Bias Modification |
| Attention ControlAttention control (AC) sessions, will consist of a standard dot-probe task (i.e., target-dot - neutral/threat stimulus 50% pairing). Thus, for AC participants, bias should remain the same, while ABM participants should show a reduced bias to threat. | Behavioural | Attention Control |
Primary outcome
Attentional Bias
Time frame: Baseline and after 6 weeks of the intervention
Reaction time difference to congruent and incongruent trials in the dot-probe task, which measure heightened attentional bias to threat.
1 secondary outcome
State and Trait Anxiety
Time frame: Baseline and after 6 weeks of the intervention
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 12 Jan 2022.
- Derived from this study: PubMed 35569575Carlson JM, Fang L, Koster EHW, Andrzejewski JA, Gilbertson H, Elwell KA, Zuidema TR. Neuroplastic changes in anterior cingulate cortex gray matter volume and functional connectivity following attention bias modification in high trait anxious individuals. Biol Psychol. 2022 Jul;172:108353. doi: 10.1016/j.biopsycho.2022.108353. Epub 2022 May 13.
- Derived from this study: PubMed 34755317Carlson JM, Fang L. Attentional bias to threat and gray matter volume morphology in high anxious individuals. Cogn Affect Behav Neurosci. 2022 Jun;22(3):600-609. doi: 10.3758/s13415-021-00968-9. Epub 2021 Nov 9.
- Individual participant dataSharing planned: Yes. Data will be uploaded to the NIMH Data Archive
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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.
Joshua M Carlson, PhD principal investigator
Northern Michigan University
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 in people with Anxiety, run by Northern Michigan University 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 8 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 12 Jan 2022. 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. 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?
Attentional Bias (time frame: Baseline and after 6 weeks of the intervention). 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 NCT03092609, 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 12 Jan 2022.