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

NCT02926352 | Completed Phase 1

• 1 other identifier: 2013-12-0068
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobias; Claustrophobia; Social Phobia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (11)

• Behavioral Approach Test - Treatment Context

  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)

  Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)

• Beck Anxiety Inventory (BAI)

  Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)

• Claustrophobia Questionnaire (CLQ)

  Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)

• Claustrophobia Concerns Questionnaire (CCQ)

  Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)

Study Arms (4)

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.

Behavioral: Extinction Training; Device: Low-Level Laser Therapy

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.

Behavioral: Extinction Training; Device: Sham Low-Level Laser Therapy

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.

Device: Low-Level Laser Therapy

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.

Device: Sham Low-Level Laser Therapy

Interventions

Extinction Training BEHAVIORAL

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

Also known as: Exposure Therapy

Extinction Training with LLLT; Extinction Training with Sham LLLT

Low-Level Laser Therapy DEVICE

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

Also known as: LLLT

Extinction Training with LLLT; LLLT alone

Sham Low-Level Laser Therapy DEVICE

Placebo dose version of LLLT.

Also known as: Sham LLLT

Extinction Training with Sham LLLT; Sham LLLT alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Laboratory for the Study of Anxiety Disorders

Austin, Texas, 78712, United States

Location

Related Publications (1)

• 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.

  PMID: 34284836 RESULT

Related Links

• Primary Outcomes Results Paper

MeSH Terms

Conditions

Phobic Disorders; Claustrophobia; Phobia, Social; Glossophobia

Interventions

Implosive Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Michael J. Telch, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Laboratory for the Study of Anxiety Disorders

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: October 6, 2016
• Study Start: August 1, 2015
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

US (1)