Anxiety & Depression Association of America

Transcranial Photobiomodulation in Anxiety Disorders

Purpose

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.

Condition

Symptoms of Anxiety

Eligibility

Eligible Ages: Between 18 Years and 100 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM)	Participants will receive attention bias assessment (ABA) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead.	Behavioral: 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. Device: 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.
Sham Comparator Arm 2: attention bias assessment (ABA), sham tPBM	Participants will receive attention bias assessment (ABA) in conjunction with sham (laser light off) transcranial photobiomodulation (tPBM) treatment to the forehead.	Behavioral: 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.
Active Comparator Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM)	Participants will receive attention bias assessment plus attention bias modification (ABA/ABM) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead.	Behavioral: 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. Device: 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.
Sham Comparator Arm 4: attention bias assessment and modification (ABA/ABM), sham tPBM	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.	Behavioral: 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Francisco Gonzalez-Lima, PhD

Study Contact

Francisco Gonzalez-Lima, Ph.D.
512-537-5257
utanxietystudy1@gmail.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.