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Transcranial Photobiomodulation in Anxiety Disorders

NCT07133893 · University of Texas at Austin
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Official title
Effects of Transcranial Photobiomodulation and Attention Bias Modification on Anxiety Symptoms and Brain Hemodynamics
About this study
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
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 target: 280 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-09-01
Estimated completion: 2028-09
Last updated: 2026-05-14
Interventions
Behavioral: Attention bias assessment and modificationDevice: Transcranial photobiomodulation
Primary outcomes
  • 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))
  • 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))
Sponsor
Francisco Gonzalez-Lima, PhD · other
Contacts & investigators
ContactFrancisco Gonzalez-Lima, Ph.D. · contact · utanxietystudy1@gmail.com · 512-537-5257
All locations (1)
The University of Texas at AustinRecruiting
Austin, Texas, United States
Transcranial Photobiomodulation in Anxiety Disorders · TrialPath