Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training
Condition: Phobias; Claustrophobia; Social Phobia
MeSH terms: Phobic Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Extinction Training; Low-Level Laser Therapy; Sham Low-Level Laser Therapy
Intervention type(s): Behavioral; Device; Device
Intervention description(s): Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.; 1064nm light used to modulate a biological function and induce a therapeutic effect.; Placebo dose version of LLLT.
Other intervention name(s): Exposure Therapy; LLLT; Sham LLLT
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: LLLT; LLLS; Low-Level Laser Stimulation; Low-Level Laser Therapy; Low-Level Light Therapy; Transcranial infrared light stimulation; Near-infrared light; Photobiomodulation; Fear Extinction; Exposure Therapy; Claustrophobia; Fear of enclosed spaces; Fear of contamination; Fear of public speaking; Anxiety sensitivity; Cytochrome oxidase; Memory consolidation; Cognitive enhancer