Clinical trial NCT02926352: Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training
Official title: Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training in the Modification of Pathological Fear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Behavioral Approach Test- Generalization Context
timeFrame: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment)
Secondary outcomes:
measure: Behavioral Approach Test - Treatment Context
timeFrame: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Claustrophobia Questionnaire (CLQ)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Claustrophobia Concerns Questionnaire (CCQ)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Obsessive Compulsive Inventory-Revised (OCI-R)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Washing Threat Questionnaire (WTQ)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Liebowitz Social Anxiety Scale Self Report Version (LSAS-SR)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Speech Anxiety Thoughts Inventory (SATI)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Anxiety sensitivity Index (ASI-3)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
measure: Body Sensations Questionnaire (BSQ)
timeFrame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Other outcomes:
Locations:
city: Austin
country: United States
facility: Laboratory for the Study of Anxiety Disorders
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Michael J. Telch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.