Transcranial Photobiomodulation in Anxiety Disorders

Not Applicable

Not yet recruiting

• Conditions: Symptoms of Anxiety

• Registration Number: NCT07133893
• Lead Sponsor: University of Texas at Austin

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.

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 Timeline

• Study First Submitted: 2025-07-24
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Study Start: 2025-09-01
• Primary Completion: 2027-09
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite cognitive score in the dot-probe task	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	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.

Trial Locations

Locations (1)

The University of Texas at Austin; 🇺🇸 Austin, Texas, United States