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

December 20, 2022 updated by: Michael J. Telch, University of Texas at Austin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Laboratory for the Study of Anxiety Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extinction Training with LLLT
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
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
Other Names:
  • Exposure Therapy
Device: Low-Level Laser Therapy
1064nm light used to modulate a biological function and induce a therapeutic effect.
Other Names:
  • LLLT
Active Comparator: Extinction Training with Sham LLLT
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
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
Other Names:
  • Exposure Therapy
Device: Sham Low-Level Laser Therapy
Placebo dose version of LLLT.
Other Names:
  • Sham LLLT
Experimental: LLLT alone
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
1064nm light used to modulate a biological function and induce a therapeutic effect.
Other Names:
  • LLLT
Sham Comparator: Sham LLLT alone
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
Placebo dose version of LLLT.
Other Names:
  • Sham LLLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
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.
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
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).
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
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).
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
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).
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
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).
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)
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).
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
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).
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
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).
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
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).
Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: Michael J. Telch, Ph.D., University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

May 4, 2020

Study Completion (Actual)

May 4, 2020

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Estimate)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-12-0068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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