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Completed

NCT Number: NCT02926352

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Laboratory for the Study of Anxiety Disorders

Austin, Texas, 78712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-65
  • 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

  • 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.
  • Psychotropic medication taken within the past 4 weeks.
  • Currently Receiving treatment for the fear domain in question.
  • 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.
  • Active neurological condition (such as epilepsy or stroke) as determined by a Medical History Questionnaire.

Treatment and study plan

Extinction Training

Behavioral

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

Other names: Exposure Therapy

Low-Level Laser Therapy

Device

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

Other names: LLLT

Sham Low-Level Laser Therapy

Device

Placebo dose version of LLLT.

Other names: Sham LLLT

Primary outcomes

  1. Behavioral Approach Test- Generalization Context

    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.

Secondary outcomes

  1. Behavioral Approach Test - Treatment Context

    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.

  2. Beck Depression Inventory-II (BDI-II)

    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.

  3. Beck Anxiety Inventory (BAI)

    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.

  4. Claustrophobia Questionnaire (CLQ)

    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).

  5. Claustrophobia Concerns Questionnaire (CCQ)

    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).

  6. Obsessive Compulsive Inventory-Revised (OCI-R)

    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).

  7. Washing Threat Questionnaire (WTQ)

    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).

  8. Liebowitz Social Anxiety Scale Self Report Version (LSAS-SR)

    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).

  9. Speech Anxiety Thoughts Inventory (SATI)

    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).

  10. Anxiety sensitivity Index (ASI-3)

    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).

  11. Body Sensations Questionnaire (BSQ)

    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).

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 6, 2016
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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