Symptoms of AnxietyNCT07133893
Transcranial Photobiomodulation in Anxiety Disorders
A study testing Attention bias assessment and modification and Transcranial photobiomodulation in people with Symptoms of Anxiety, run by Francisco Gonzalez-Lima, PhD at 1 site in United States.
Trial summary
The investigators have previously shown that safe, non-invasive methods of brain stimulation such as the administration of transcranial infrared light can result in improvements to cognition and emotion. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptoms of Anxiety
- What is being tested?
- Attention bias assessment and modification and Transcranial photobiomodulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- State-Trait Anxiety Index (STAI) questionnaire score between 40-59 (indicates moderate sub-clinical anxiety)
- Patient Health Questionnaire (PHQ-9) score between 1-9 (indicates minimal to mild sub-clinical depression)
Who cannot join
- STAI score less than 40 or greater than 59
- PHQ-9 score greater than 9
- Medication instability (i.e., medication change within 6 weeks)
- Indicated suicidal ideation
- Currently receiving tPBM treatment
- Current pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78712
Francisco Gonzalez-Lima, Ph.D., 512-537-5257, utbrainproject@gmail.com
Francisco Gonzalez-Lima, Ph.D.
About this study
Official title: Effects of Transcranial Photobiomodulation and Attention Bias Modification on Anxiety Symptoms and Brain Hemodynamics
The investigators have previously shown that safe, non-invasive methods of brain stimulation such as the administration of transcranial infrared light can result in improvements to cognition and emotion. The investigators hypothesize that transcranial photobiomodulation (tPBM) can be used in conjunction with attention bias assessment and modification to reduce anxiety symptoms in individuals with sub-clinical anxiety.
Read the detailed description
The investigators will conduct two studies: one examining the efficacy of transcranial photobiomodulation as a standalone treatment to alleviate sub-clinical anxiety symptoms and another evaluating the role of transcranial photobiomodulation as an adjunct to a form of cognitive behavioral therapy in anxiety treatment. The investigators will recruit individuals with sub-clinical anxiety and use attention bias assessment (ABA) to assess levels of anxiety, and then use attention bias modification (ABM) to reduce levels of anxiety. Brain activity will be monitored using functional near-infrared spectroscopy (fNIRS).
An online prescreen questionnaire will be used to determine participant eligibility. No medical records are accessed/obtained for verifying inclusion/exclusion criteria. Informed consent is obtained during the first in-person visit. Participants fill out questionnaires to assess their medical history and anxiety/depression symptoms. The participants then participate in either ABA or ABA/ABM while wearing the fNIRS headset before and after transcranial photobiomodulation treatment or sham. Both studies will comprise three in-person visits with an online follow-up a week later. In this single-blind, sham-controlled experiment, block randomization will be performed to minimize selection bias and allocation bias.
- Conditions
- Symptoms of Anxiety
- Being tested
- Attention bias assessment and modification, Transcranial photobiomodulation
- Keywords
- Photobiomodulation, Sub-clinical anxiety, Near-infrared spectroscopy (NIRS), attention bias modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention bias assessment and modificationBehavioural
Attention bias assessment and modification involve two versions of the dot-probe task. These tasks are based on the premise that repeated attention shifts can retrain attentional biases, with the expectation that reducing attentional bias toward threats will alleviate sub-clinical anxiety symptoms.
Transcranial photobiomodulationDevice
Participants will receive near-infrared light at 1064 nanometers to the right side of the forehead for 8 minutes. The investigators have introduced this form of transcranial photobiomodulation (tPBM) as a means of human cognitive enhancement, and as an adjunct for attention bias modification for the reduction of symptoms of depression. In the present study, the investigators wish to extend these findings to the use of attention bias modification for the reduction of sub-clinical anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM) | Active comparator | Participants will receive attention bias assessment (ABA) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead. Receives: Behavioral: Attention bias assessment and modification; Device: Transcranial photobiomodulation |
| Arm 2: attention bias assessment (ABA), sham tPBM | Sham comparator | Participants will receive attention bias assessment (ABA) in conjunction with sham (laser light off) transcranial photobiomodulation (tPBM) treatment to the forehead. Receives: Behavioral: Attention bias assessment and modification |
| Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM) | Active comparator | Participants will receive attention bias assessment plus attention bias modification (ABA/ABM) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead. Receives: Behavioral: Attention bias assessment and modification; Device: Transcranial photobiomodulation |
| Arm 4: attention bias assessment and modification (ABA/ABM), sham tPBM | Sham comparator | Participants will receive attention bias assessment plus attention bias modification (ABA/ABM) in conjunction with sham (laser light off) transcranial photobiomodulation (tPBM) treatment to the forehead. Receives: Behavioral: Attention bias assessment and modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite cognitive score in the dot-probe task
The participant pays attention to a fixation cross in the center of the screen, which is followed by the presentation of two images on the left and right of the screen. One of these new images is a "threat" image, while the other is neutral. Following each trial of stimuli presentation, a probe type ("<" vs. ">") will randomly appear in the same location previously occupied by either the threatening or neutral image and remain on the screen until the participant has responded. Participants respond to the probe type by pressing the "←" or the "→" arrow key, respectively, on the keyboard, as quickly but as accurately as possible. The probe randomly replaces the neutral or the negative stimulus with equal frequency (50/50). The single primary outcome is the composite cognitive score which is calculated on the basis of performance in this task.
Measured: Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)
Change in concentration of oxygenated hemoglobin as measured by functional near-infrared spectroscopy
Hemodynamic activity is assessed non-invasively using near-infrared spectroscopy. In this procedure, a participant wears an apparatus on the head which contains an array of light sources and detectors. Light is applied to the surface of the skin, and a small fraction of the light passes through the underlying tissue and reflects back to the surface, where it is detected and the number of photons at specific light wavelengths are counted by a computer. This photon count can be converted to changes in concentration of metabolic indices, such as oxygenated/deoxygenated hemoglobin.
Measured: Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Symptoms of 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Gonzalez-Lima, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Gonzalez-Lima, PhD, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133893
- Sponsor's protocol ID
- STUDY00007224
- Status last verified
- May 2026
- First submitted
- 24 Jul 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: What data will be shared? Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices). A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided. This data will include anonymized individual participant demographic information and all outcome variables (cognitive task data, spectroscopy data).
Publications
Barrett DW, Beevers CG, Gonzalez-Lima F. Augmenting Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder With Transcranial Infrared Laser Stimulation. Biol Psychiatry Glob Open Sci. 2025 Jan 9;5(2):100449. doi: 10.1016/j.bpsgos.2025.100449. eCollection 2025 Mar.
PubMed 39990627Disner SG, Beevers CG, Gonzalez-Lima F. Transcranial Laser Stimulation as Neuroenhancement for Attention Bias Modification in Adults with Elevated Depression Symptoms. Brain Stimul. 2016 Sep-Oct;9(5):780-787. doi: 10.1016/j.brs.2016.05.009. Epub 2016 May 24.
PubMed 27267860Zaizar ED, Papini S, Gonzalez-Lima F, Telch MJ. Singular and combined effects of transcranial infrared laser stimulation and exposure therapy on pathological fear: a randomized clinical trial. Psychol Med. 2023 Feb;53(3):908-917. doi: 10.1017/S0033291721002270. Epub 2021 Jul 21.
PubMed 34284836
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Photobiomodulation and Attention Bias Modification on Anxiety Symptoms and Brain Hemodynamics
- ClinicalTrials.gov ID
- NCT07133893
- Acronym / sponsor ID
- STUDY00007224
- Conditions
- Symptoms of Anxiety
- Keywords
- Photobiomodulation, Sub-clinical anxiety, Near-infrared spectroscopy (NIRS), attention bias modification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Francisco Gonzalez-Lima, PhDUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 Aug 2025 (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.
The investigators have previously shown that safe, non-invasive methods of brain stimulation such as the administration of transcranial infrared light can result in improvements to cognition and emotion. The investigators hypothesize that transcranial photobiomodulation (tPBM) can be used in conjunction with attention bias assessment and modification to reduce anxiety symptoms in individuals with sub-clinical anxiety.
Detailed description
The investigators will conduct two studies: one examining the efficacy of transcranial photobiomodulation as a standalone treatment to alleviate sub-clinical anxiety symptoms and another evaluating the role of transcranial photobiomodulation as an adjunct to a form of cognitive behavioral therapy in anxiety treatment. The investigators will recruit individuals with sub-clinical anxiety and use attention bias assessment (ABA) to assess levels of anxiety, and then use attention bias modification (ABM) to reduce levels of anxiety. Brain activity will be monitored using functional near-infrared spectroscopy (fNIRS).
An online prescreen questionnaire will be used to determine participant eligibility. No medical records are accessed/obtained for verifying inclusion/exclusion criteria. Informed consent is obtained during the first in-person visit. Participants fill out questionnaires to assess their medical history and anxiety/depression symptoms. The participants then participate in either ABA or ABA/ABM while wearing the fNIRS headset before and after transcranial photobiomodulation treatment or sham. Both studies will comprise three in-person visits with an online follow-up a week later. In this single-blind, sham-controlled experiment, block randomization will be performed to minimize selection bias and allocation bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM) | Active comparator | Behavioral: Attention bias assessment and modification, Device: Transcranial photobiomodulationParticipants will receive attention bias assessment (ABA) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead. |
| Arm 2: attention bias assessment (ABA), sham tPBM | Sham comparator | Behavioral: Attention bias assessment and modificationParticipants will receive attention bias assessment (ABA) in conjunction with sham (laser light off) transcranial photobiomodulation (tPBM) treatment to the forehead. |
| Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM) | Active comparator | Behavioral: Attention bias assessment and modification, Device: Transcranial photobiomodulationParticipants will receive attention bias assessment plus attention bias modification (ABA/ABM) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead. |
| Arm 4: attention bias assessment and modification (ABA/ABM), sham tPBM | Sham comparator | Behavioral: Attention bias assessment and modificationParticipants will receive attention bias assessment plus attention bias modification (ABA/ABM) in conjunction with sham (laser light off) transcranial photobiomodulation (tPBM) treatment to the forehead. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- State-Trait Anxiety Index (STAI) questionnaire score between 40-59 (indicates moderate sub-clinical anxiety)
- Patient Health Questionnaire (PHQ-9) score between 1-9 (indicates minimal to mild sub-clinical depression)
Key exclusion criteria (6 listed)
- STAI score less than 40 or greater than 59
- PHQ-9 score greater than 9
- Medication instability (i.e., medication change within 6 weeks)
- Indicated suicidal ideation
- Currently receiving tPBM treatment
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 assessment and modificationAttention bias assessment and modification involve two versions of the dot-probe task. These tasks are based on the premise that repeated attention shifts can retrain attentional biases, with the expectation that reducing attentional bias toward threats will alleviate sub-clinical anxiety symptoms. | Behavioural | Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM), Arm 2: attention bias assessment (ABA), sham tPBM, Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM), Arm 4: attention bias assessment and modification (ABA/ABM), sham tPBM |
| Transcranial photobiomodulationParticipants will receive near-infrared light at 1064 nanometers to the right side of the forehead for 8 minutes. The investigators have introduced this form of transcranial photobiomodulation (tPBM) as a means of human cognitive enhancement, and as an adjunct for attention bias modification for the reduction of symptoms of depression. In the present study, the investigators wish to extend these findings to the use of attention bias modification for the reduction of sub-clinical anxiety. | Device | Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM), Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM) |
Primary outcome
Composite cognitive score in the dot-probe task
Time frame: Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)
The participant pays attention to a fixation cross in the center of the screen, which is followed by the presentation of two images on the left and right of the screen. One of these new images is a "threat" image, while the other is neutral. Following each trial of stimuli presentation, a probe type ("<" vs. ">") will randomly appear in the same location previously occupied by either the threatening or neutral image and remain on the screen until the participant has responded. Participants respond to the probe type by pressing the "←" or the "→" arrow key, respectively, on the keyboard, as quickly but as accurately as possible. The probe randomly replaces the neutral or the negative stimulus with equal frequency (50/50). The single primary outcome is the composite cognitive score which is calculated on the basis of performance in this task.
Change in concentration of oxygenated hemoglobin as measured by functional near-infrared spectroscopy
Time frame: Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)
Hemodynamic activity is assessed non-invasively using near-infrared spectroscopy. In this procedure, a participant wears an apparatus on the head which contains an array of light sources and detectors. Light is applied to the surface of the skin, and a small fraction of the light passes through the underlying tissue and reflects back to the surface, where it is detected and the number of photons at specific light wavelengths are counted by a computer. This photon count can be converted to changes in concentration of metabolic indices, such as oxygenated/deoxygenated hemoglobin.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 39990627Barrett DW, Beevers CG, Gonzalez-Lima F. Augmenting Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder With Transcranial Infrared Laser Stimulation. Biol Psychiatry Glob Open Sci. 2025 Jan 9;5(2):100449. doi: 10.1016/j.bpsgos.2025.100449. eCollection 2025 Mar.
- Background: PubMed 27267860Disner SG, Beevers CG, Gonzalez-Lima F. Transcranial Laser Stimulation as Neuroenhancement for Attention Bias Modification in Adults with Elevated Depression Symptoms. Brain Stimul. 2016 Sep-Oct;9(5):780-787. doi: 10.1016/j.brs.2016.05.009. Epub 2016 May 24.
- Background: PubMed 34284836Zaizar ED, Papini S, Gonzalez-Lima F, Telch MJ. Singular and combined effects of transcranial infrared laser stimulation and exposure therapy on pathological fear: a randomized clinical trial. Psychol Med. 2023 Feb;53(3):908-917. doi: 10.1017/S0033291721002270. Epub 2021 Jul 21.
- Gonzalez-Lima Lab StudiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. What data will be shared? Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices). A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided. This data will include anonymized individual participant demographic information and all outcome variables (cognitive task data, spectroscopy data).
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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.
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 assessment and modification and Transcranial photobiomodulation in people with Symptoms of Anxiety, run by Francisco Gonzalez-Lima, PhD 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Gonzalez-Lima, Ph.D. (512-537-5257, utanxietystudy1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite cognitive score in the dot-probe task (time frame: Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)). 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?
On the ClinicalTrials.gov record for NCT07133893, which also lists 3 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 14 May 2026.