Recruiting

tPBM & Attention Bias

Sponsor:

Francisco Gonzalez-Lima, PhD

Code:

NCT07133893

Conditions

Symptoms of Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Attention bias assessment and modification

Transcranial photobiomodulation

Study Details

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

Study ID

NCT07133893

Start date

Sep 1, 2025

Status verified date

May, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM)

Participants will receive attention bias assessment (ABA) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead.

sham comparator: Arm 2: attention bias assessment (ABA), sham tPBM

Participants will receive attention bias assessment (ABA) in conjunction with sham (laser light off) transcranial photobiomodulation (tPBM) treatment to the forehead.

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

Participants will receive attention bias assessment plus attention bias modification (ABA/ABM) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead.

sham comparator: Arm 4: attention bias assessment and modification (ABA/ABM), sham tPBM

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.

Interventions

Attention bias assessment and modification

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 photobiomodulation

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.

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Francisco Gonzalez-Lima, Ph.D.

512-537-5257utanxietystudy1@gmail.com

Locations

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Francisco Gonzalez-Lima, Ph.D.

512-537-5257utbrainproject@gmail.com

Principal Investigator:

Francisco Gonzalez-Lima, Ph.D.

More Information

Sponsor

Francisco Gonzalez-Lima, PhD

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Francisco Gonzalez-Lima, PhD on 2026-05-14.