跳至主要内容
临床试验/NCT07133893
NCT07133893招募中不适用

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

Francisco Gonzalez-Lima, PhD2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
280
试验地点
2
主要终点
Composite cognitive score in the dot-probe task

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

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

Active Comparator

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

干预措施: Attention bias assessment and modification (Behavioral)

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

Active Comparator

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

干预措施: Transcranial photobiomodulation (Device)

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

Sham Comparator

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

干预措施: Attention bias assessment and modification (Behavioral)

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

Active Comparator

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

干预措施: Attention bias assessment and modification (Behavioral)

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

Active Comparator

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

干预措施: Transcranial photobiomodulation (Device)

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

Sham Comparator

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.

干预措施: Attention bias assessment and modification (Behavioral)

结局指标

主要结局

Composite cognitive score in the dot-probe task

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Francisco Gonzalez-Lima, PhD

Professor; Director, Texas Consortium in Behavioral Neuroscience

University of Texas at Austin

研究点 (2)

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