Transcranial Photobiomodulation in Anxiety Disorders

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Symptoms of Anxiety

Treatments: Device: Transcranial photobiomodulation; Behavioral: Attention bias assessment and modification

Study type: Interventional

Funder types: Other

Identifiers

NCT07133893

STUDY00007224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 4 patient groups

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

Active Comparator group

Description:

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

Treatment:

Behavioral: Attention bias assessment and modification

Device: Transcranial photobiomodulation

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

Sham Comparator group

Description:

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

Treatment:

Behavioral: Attention bias assessment and modification

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

Active Comparator group

Description:

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

Treatment:

Behavioral: Attention bias assessment and modification

Device: Transcranial photobiomodulation

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

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Attention bias assessment and modification