Transcranial Photobiomodulation in Anxiety Disorders

Part of paid clinical trials in Austin, Texas.

Sponsor
Francisco Gonzalez-Lima, PhD
Study ID
NCT07133893
Status
Recruiting

Conditions

  • Symptoms of Anxiety

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Attention bias assessment and modification — BEHAVIORAL
    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.
  • Transcranial photobiomodulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas at AustinAustinTexas78712
Francisco Gonzalez-Lima, Ph.D.
512-537-5257
Francisco Gonzalez-Lima, Ph.D. (PRINCIPAL_INVESTIGATOR)

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