Transcranial Photobiomodulation in Anxiety Disorders

Официальное название

Effects of Transcranial Photobiomodulation and Attention Bias Modification on Anxiety Symptoms and Brain Hemodynamics

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Устройство 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.

Первичные конечные точки

• Composite cognitive score in the dot-probe task [Срок оценки: 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 [Срок оценки: Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas at Austin — Austin

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07133893 · STUDY00007224

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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