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NCT07133893NARecruitingAccepts Healthy Volunteers

Transcranial Photobiomodulation in Anxiety Disorders

Francisco Gonzalez-Lima, PhD

Start Date

9/1/2025

Completion Date

9/1/2028

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.

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.

Eligibility Criteria

Age Range: 18 years to 100 years

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

Interventions

BEHAVIORAL

Attention bias assessment and modification

DEVICE

Transcranial photobiomodulation

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Conditions

Symptoms of Anxiety

Locations

The University of Texas at Austin

Austin, Texas 78712

United States