Transcranial Photobiomodulation in Anxiety Disorders

NCT07133893 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00007224
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Symptoms of Anxiety

Keywords

Photobiomodulation; Sub-clinical anxiety; Near-infrared spectroscopy (NIRS); attention bias modification

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)

Study Arms (4)

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.

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.

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.

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.

Behavioral: Attention bias assessment and modification

Interventions

Attention bias assessment and modification BEHAVIORAL

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.

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 photobiomodulation DEVICE

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.

Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM); Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (3)

• 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.

  PMID: 39990627 BACKGROUND

• Disner 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.

  PMID: 27267860 BACKGROUND

• Zaizar 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.

  PMID: 34284836 BACKGROUND

Related Links

• Gonzalez-Lima Lab Studies

Central Study Contacts

Francisco Gonzalez-Lima, Ph.D.

CONTACT

512-537-5257; utanxietystudy1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: The raw data will be made available by the researchers upon reasonable request by any qualified doctoral researcher (PhD, MD). They will be granted access by contacting the corresponding author/principal investigator (F. Gonzalez-Lima, utbrainproject@gmail.com). It will be made available to qualified researchers whose proposed use of the data has been approved by an independent review committee (Institutional Review Board) identified for the purpose of individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our University's shared network drive, but without investigator support other than deposited metadata.

Locations

US (1)