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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extinction Training with LLLT | Experimental | 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. |
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| Extinction Training with Sham LLLT | Active Comparator | 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. |
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| LLLT alone | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extinction Training | Behavioral | Up to 40 min. of self-directed repeated exposure to a fear-provoking situation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J. Telch, Ph.D. | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for the Study of Anxiety Disorders | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34284836 | Result | 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. |
| Label | URL |
|---|---|
| Primary Outcomes Results Paper | View source |
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| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D000098452 | Claustrophobia |
| D000072861 | Phobia, Social |
| C000719203 | Glossophobia |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Sham LLLT alone | Sham Comparator | 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. |
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| Low-Level Laser Therapy | Device | 1064nm light used to modulate a biological function and induce a therapeutic effect. |
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| Sham Low-Level Laser Therapy | Device | Placebo dose version of LLLT. |
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| Beck Depression Inventory-II (BDI-II) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |