Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training
NCT ID: NCT02926352
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
112 participants
INTERVENTIONAL
2015-08-01
2020-05-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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.
Extinction Training
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
Low-Level Laser Therapy
1064nm light used to modulate a biological function and induce a therapeutic effect.
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.
Extinction Training
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
Sham Low-Level Laser Therapy
Placebo dose version of LLLT.
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.
Low-Level Laser Therapy
1064nm light used to modulate a biological function and induce a therapeutic effect.
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.
Sham Low-Level Laser Therapy
Placebo dose version of LLLT.
Interventions
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Extinction Training
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
Low-Level Laser Therapy
1064nm light used to modulate a biological function and induce a therapeutic effect.
Sham Low-Level Laser Therapy
Placebo dose version of LLLT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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Michael J. Telch
Director of the Laboratory for the Study of Anxiety Disorders
Principal Investigators
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Michael J. Telch, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Austin
Locations
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Laboratory for the Study of Anxiety Disorders
Austin, Texas, United States
Countries
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References
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Zaizar ED, Papini S, Gonzalez-Lima F, Telch MJ. Singular and combined effects of transcranial infrared laser stimulation and exposure therapy on pathological fear: a randomized clinical trial. Psychol Med. 2023 Feb;53(3):908-917. doi: 10.1017/S0033291721002270. Epub 2021 Jul 21.
Related Links
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Primary Outcomes Results Paper
Other Identifiers
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2013-12-0068
Identifier Type: -
Identifier Source: org_study_id