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

Social Phobia Clinical Trial

Official title:

Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training in the Modification of Pathological Fear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926352
• Other study ID #: 2013-12-0068
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 1, 2015
• Est. completion date: May 4, 2020

Study information

• Verified date: December 2022
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Claustrophobia
• Phobia, Social
• Phobias
• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• Extinction Training
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.

Device:
• 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.

Locations

Country	Name	City	State
United States	Laboratory for the Study of Anxiety Disorders	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & 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. 2021 Jul 21:1-10. doi: 10.1017/S0033291721002270. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Primary Outcomes Results Paper