A Phase 1/2 interventional study of Extinction Training and Low-Level Laser Therapy in Phobias, Claustrophobia and Social Phobia, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-28.
Sponsored by University of Texas at Austin · Phase 1/2, Interventional, and Treatment
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.
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.
367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.
This study's enrollment of 112 is above the median of 76 across 338 interventional studies indexed under Phobia, Social.
Browse Phobia, Social studies →University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Compared within Phobia, Social, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Phobic Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Participants will receive one-session of fear extinction training tailored to the participant's specific fear domain. 15 minutes after fear extinction, participants will receive 8 minutes of Low-Level Laser Therapy stimulation. The laser will be directed at two areas on the forehead: bilateral frontal points Fp1 and Fp2 (on the EEG electrode placement system; to stimulate the vmPFC). Each area will be stimulated for 4 minutes. Treatment will consist of alternating between each of these points after each minute.
Behavioral: Extinction Training · Device: Low-Level Laser Therapy
Participants will receive one-session of fear extinction training tailored to the participant's specific fear. 15 minutes after fear extinction, participants will receive 8 minutes of Sham Low-Level Laser Therapy stimulation. The laser will be directed at two areas on the forehead: bilateral frontal points Fp1 and Fp2 (on the EEG electrode placement system). The procedure will consist of alternating between each of these points after each minute. However, each point will receive only a brief (5-second) treatment to the intended site on the forehead, followed by 55 seconds of no treatment, for each one-minute cycle, functioning as a placebo dose of the treatment.
Behavioral: Extinction Training · Device: Sham Low-Level Laser Therapy
Participants will receive 8 minutes of Low-Level Laser Therapy stimulation. The laser will be targeted first at the left forehead point F3 and then at the right forehead point F4 (on the EEG electrode placement system). F3 corresponds with the left dorsolateral prefrontal cortex and F4 corresponds with the right dorsolateral prefrontal cortex. Each area will be stimulated for 4 minutes. Treatment will consist of alternating between each of these points after each minute.
Device: Low-Level Laser Therapy
Participants will receive 8 minutes of Sham Low-Level Laser Therapy stimulation. The laser will be targeted first at the left forehead point F3 and then at the right forehead point F4 (on the EEG electrode placement system). The procedure will consist of alternating between each of these points after each minute. However, each point will receive only a brief (5-second) treatment to the intended site on the forehead, followed by 55 seconds of no treatment, for each one-minute cycle, functioning as a placebo dose of the treatment.
Device: Sham Low-Level Laser Therapy
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
Also known as: Exposure Therapy
1064nm light used to modulate a biological function and induce a therapeutic effect.
Also known as: LLLT
Placebo dose version of LLLT.
Also known as: Sham LLLT
Behavioral Approach Test- Generalization Context
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)
Behavioral Approach Test - Treatment Context
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); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment)
Beck Depression Inventory-II (BDI-II)
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)
Beck Anxiety Inventory (BAI)
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)
Claustrophobia Questionnaire (CLQ)
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)
Claustrophobia Concerns Questionnaire (CCQ)
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)
Obsessive Compulsive Inventory-Revised (OCI-R)
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)
Washing Threat Questionnaire (WTQ)
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)
Liebowitz Social Anxiety Scale Self Report Version (LSAS-SR)
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)
Speech Anxiety Thoughts Inventory (SATI)
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)
Anxiety sensitivity Index (ASI-3)
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)
Body Sensations Questionnaire (BSQ)
Change in fear ratings in relation to somatic 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)
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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