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

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ClinicalTrials.gov Identifier: NCT02926352
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Michael J. Telch, University of Texas at Austin

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Phobias Claustrophobia Social Phobia Behavioral: Extinction Training Device: Low-Level Laser Therapy Device: Sham Low-Level Laser Therapy Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training in the Modification of Pathological Fear
Study Start Date : August 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: Exposure Therapy

Device: Low-Level Laser Therapy
1064nm light used to modulate a biological function and induce a therapeutic effect.
Other Name: 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 Name: Exposure Therapy

Device: Sham Low-Level Laser Therapy
Placebo dose version of LLLT.
Other Name: 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 Name: 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 Name: Sham LLLT




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926352


Contacts
Contact: Michael J. Telch, Ph.D. (512) 404-9118 Telch@austin.utexas.edu
Contact: Eric D. Zaizar, BA (830)-370-4044 eric.zaizar@utexas.edu

Locations
United States, Texas
Laboratory for the Study of Anxiety Disorders Recruiting
Austin, Texas, United States, 78712
Contact: Michael J. Telch, Ph.D.    512-404-9118    Telch@austin.utexas.edu   
Contact: Eric D. Zaizar, BA    (830)-370-4044    eric.zaizar@utexas.edu   
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Michael J. Telch, Ph.D. University of Texas at Austin

Responsible Party: Michael J. Telch, Director of the Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02926352     History of Changes
Other Study ID Numbers: 2013-12-0068
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by Michael J. Telch, University of Texas at Austin:
LLLT
LLLS
Low-Level Laser Stimulation
Low-Level Laser Therapy
Low-Level Light Therapy
Transcranial infrared light stimulation
Near-infrared light
Photobiomodulation
Fear Extinction
Exposure Therapy
Claustrophobia
Fear of enclosed spaces
Fear of contamination
Fear of public speaking
Anxiety sensitivity
Cytochrome oxidase
Memory consolidation
Cognitive enhancer

Additional relevant MeSH terms:
Phobic Disorders
Phobia, Social
Anxiety Disorders
Mental Disorders