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

University of Texas at Austin112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

112

Conditions

Phobias Claustrophobia Social Phobia

Interventions

Extinction TrainingBEHAVIORAL

Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.

Low-Level Laser TherapyDEVICE

1064nm light used to modulate a biological function and induce a therapeutic effect.

Sham Low-Level Laser TherapyDEVICE

Placebo dose version of LLLT.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ages 18-65 2. Behavioral Approach Test (BAT) peak fear rating equal to or greater than 50/100 on both BATs (i.e., treatment and generalization contexts). Exclusion Criteria: 1. High risk for suicide as determined by a clinical assessment, which will occur if a participant indicates that they are currently experiencing suicidal ideation on the depression module of the Mini International Neuropsychiatric Inventory, or on item 9 of the Beck Depression Inventory. 2. Psychotropic medication taken within the past 4 weeks. 3. Currently Receiving treatment for the fear domain in question. 4. Presence of a medical condition (i.e., pregnancy, seizure disorder, respiratory disorder, cardiovascular disease) that would contraindicate participation in one or more treatment or assessment activities as determined by a Medical History Questionnaire. 5. Active neurological condition (such as epilepsy or stroke) as determined by a Medical History Questionnaire.

Locations (1)

Laboratory for the Study of Anxiety Disorders

Austin, Texas, United States

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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