Laboratory for the Study of Anxiety Disorders
Austin, Texas, 78712, United States
NCT Number: NCT02926352
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
Austin, Texas, 78712, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
Other names: Exposure Therapy
1064nm light used to modulate a biological function and induce a therapeutic effect.
Other names: LLLT
Placebo dose version of LLLT.
Other names: Sham LLLT
Time frame: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment)
Change in fear response as indicated by behavioral approach and peak subjective fear ratings (0-100) in a generalization context (different from the treatment context) from baseline to follow-up.
Time frame: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment)
Change in fear response as indicated by behavioral approach and peak subjective fear ratings (0-100) in a generalization context (different from the treatment context) from baseline to post-treatment.
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in depression symptoms from baseline to follow-up.
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in anxiety symptoms from baseline to follow-up.
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in claustrophobic cognitions from baseline to follow-up (for participants in the fear of enclosed spaces domain).
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in claustrophobic cognitions from baseline to follow-up (for participants in the fear of enclosed spaces domain).
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in obsessional symptoms from baseline to follow-up (for participants in the fear of contamination domain).
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in threat perceptions related to not being able to wash hands from baseline to follow-up (for participants in the fear of contamination domain).
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in anxiety and avoidance for social situations from baseline to follow-up (for participants in the fear of public speaking domain).
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in maladaptive cognitions associated with speech anxiety from baseline to follow-up (for participants in the fear of public speaking domain).
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in fear ratings of physical, cognitive, and social anxiety reactions or sensations from baseline to follow-up (for participants in the anxiety sensitivity domain).
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Change in fear ratings in relation to somatic sensations from baseline to follow-up (for participants in the anxiety sensitivity domain).
University of Texas at Austin
Other
Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training in the Modification of Pathological Fear
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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