NCT02926352

Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training

Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training in the Modification of Pathological Fear

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

There are two specific aims for this study. Aim 1 is to test whether low-level laser therapy (LLLT) can enhance the efficacy of fear extinction training in the modification of pathological fear. Aim 2 is to investigate the efficacy of low-level laser therapy (LLLT) as a stand-alone intervention for anxiety/phobias.

Detailed description

Preliminary research with non-human animals suggests that LLLT (i.e., ultra low doses of transcranial infrared light) can enhance the retention of fear extinction learning by up regulating neuronal metabolic activity when applied to the ventromedial prefrontal cortex (vmPFC). Furthermore, evidence from a previous uncontrolled trial with humans suggests that LLLT (outside the context of extinction training) can lead to a significant decrease in symptoms of depression and anxiety when applied to the right and left dorsolateral prefrontal cortices (dlPFC). The first aim of this study is to test whether LLLT can boost fear reduction after extinction training in humans. A second aim of this study is to investigate the efficacy of LLLT as a stand-alone anxiolytic intervention in a randomized controlled trial. Individuals between the ages of 18-65 with elevated fear in any of one of four domains (e.g., fear of enclosed spaces, fear of contamination, fear of public speaking, or anxiety sensitivity) are randomly assigned to one of four treatment arms (1) Extinction Training with LLLT, (2) Extinction Training with Sham LLLT, (3) LLLT alone, or (4) Sham LLLT alone. To determine eligibility, all participants undergo an online prescreen and a face-to-face screening assessment. Participants who qualify for the study then complete a baseline (pre-treatment) assessment, followed immediately by the treatment procedure and a post-treatment assessment. Participants return to the lab an average of 14 days after treatment to complete a follow-up assessment. Participants complete two behavioral approach tests (in the treatment context and in the generalization context) at baseline, post-treatment, and follow-up, and a battery of self-report questionnaires at baseline and follow-up.

Conditions

• Phobias
• Claustrophobia
• Social Phobia

Interventions

Type	Name	Description
BEHAVIORAL	Extinction Training	Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
DEVICE	Low-Level Laser Therapy	1064nm light used to modulate a biological function and induce a therapeutic effect.
DEVICE	Sham Low-Level Laser Therapy	Placebo dose version of LLLT.

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-05-04
• Completion: 2020-05-04
• First posted: 2016-10-06
• Last updated: 2022-12-28

Locations

1 site across 1 country: United States