Transcranial Photobiomodulation for Anxiety

FG
Overseen ByFrancisco Gonzalez-Lima, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas at Austin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method using light therapy on the forehead, known as transcranial photobiomodulation (tPBM), to reduce anxiety. Researchers are testing whether tPBM, combined with techniques to alter attention focus, can ease symptoms in individuals with mild anxiety. Participants will receive either the real light therapy or a placebo version to compare results. This trial suits those experiencing moderate anxiety symptoms who are not on unstable medications. As an unphased trial, participants can contribute to innovative research that may lead to new anxiety treatments.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires that your medication has been stable for at least 6 weeks. If you've recently changed medications, you might not be eligible.

What prior data suggests that transcranial photobiomodulation is safe for reducing anxiety symptoms?

Research has shown that transcranial photobiomodulation (tPBM) is generally safe and non-invasive. Although large studies are limited, smaller studies have not identified any serious safety issues. Participants have tolerated the treatment well, and it is considered affordable and effective. Reviews of this therapy for brain diseases suggest it may help conditions like anxiety without major side effects. As a non-invasive treatment, tPBM does not involve surgery or breaking the skin, often making it safer than other treatments. However, more consistent data on its safety is still needed for wider use.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for anxiety, which typically involve medications like SSRIs or benzodiazepines, transcranial photobiomodulation (tPBM) uses light to stimulate brain activity. This method is unique because it targets specific areas of the brain directly through the forehead without the need for drugs, potentially reducing side effects. Researchers are excited about tPBM because it could offer a quicker onset of relief for anxiety symptoms compared to traditional medications, which often take several weeks to show effectiveness. Additionally, this non-invasive technique might provide a new option for those who do not respond well to existing treatments.

What evidence suggests that this trial's treatments could be effective for reducing anxiety symptoms?

Research shows that transcranial photobiomodulation (tPBM) may help reduce anxiety. Studies have found that tPBM significantly improved anxiety in people treated for other conditions, with benefits lasting at least a month. Another study found tPBM effective and well-tolerated by people with generalized anxiety disorder (GAD). In this trial, some participants will receive active tPBM treatment, while others will receive a sham tPBM treatment. Additionally, using tPBM with other treatments can enhance the effects of standard medications like SSRIs, a type of antidepressant. These findings suggest that tPBM could help ease anxiety symptoms.34678

Are You a Good Fit for This Trial?

This trial is for adults with moderate sub-clinical anxiety, as indicated by specific scores on the State-Trait Anxiety Index. Participants should not be pregnant, undergoing current tPBM treatment, have had recent medication changes, or show suicidal thoughts. They must also score within a certain range on a depression questionnaire.

Inclusion Criteria

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)
I am 18 years old or older.

Exclusion Criteria

Current pregnancy
I am currently undergoing tPBM treatment.
Medication instability (i.e., medication change within 6 weeks)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
Online prescreen questionnaire

Treatment

Participants receive transcranial photobiomodulation (tPBM) or sham treatment in conjunction with attention bias assessment and modification (ABA/ABM)

2 weeks
3 in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 online follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Attention bias assessment and modification
  • Transcranial Photobiomodulation
Trial Overview The study tests if transcranial photobiomodulation (tPBM), which involves shining infrared light on the brain, can reduce anxiety when combined with attention bias assessment and modification techniques.
How Is the Trial Designed?
4Treatment groups
Active Control
Placebo Group
Group I: Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM)Active Control2 Interventions
Group II: Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM)Active Control2 Interventions
Group III: Arm 4: attention bias assessment and modification (ABA/ABM), sham tPBMPlacebo Group1 Intervention
Group IV: Arm 2: attention bias assessment (ABA), sham tPBMPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

Citations

The effectiveness of Transcranial Photobiomodulation therapy ...tPBMT led to significant improvements in anxiety, depression, and opioid craving among individuals in MMT, and these improvements were sustained at one month ...
a double-blind, randomized, controlled trialtPBMT led to significant improvements in anxiety, depression, and opioid craving among individuals in MMT, and these improvements were sustained at one month ...
Transcranial Photobiomodulation in Anxiety DisordersThe investigators will conduct two studies: one examining the efficacy of transcranial photobiomodulation as a standalone treatment to alleviate sub ...
Transcranial Photobiomodulation with Near-Infrared Light ...In our pilot trial, t-PBM NIR for the treatment of GAD appeared effective and well tolerated, with no serious adverse events. Most noticeably, participants who ...
Transcranial photobiomodulation as an adjunctive therapy ...Transcranial photobiomodulation as adjunct therapy may improve anxiety and depression. •. Transcranial photobiomodulation may enhance SSRI effects. •.
Tolerability and Safety of Transcranial Photobiomodulation ...Consistent data on its safety profile are required for the widespread use and administration of t-PBM. However, no large clinical trials have ...
Transcranial photobiomodulation for brain diseases: review of ...Transcranial photobiomodulation (tPBM) is a promising technology for treating brain diseases, due to its effectiveness, non-invasiveness, and affordability.
New Study Will Examine Transcranial Photobiomodulation ...Preliminary data suggests t-PBM may be efficacious in improving cognition in people with early Alzheimer's dementia (AD) and mild cognitive impairment (MCI).
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