PhobiasPhase 1/2NCT02926352

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

A Phase 1/2 study testing Extinction Training and Low-Level Laser Therapy in people with Phobias and Claustrophobia, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Phobias, Claustrophobia, Social Phobia
What is being tested?: Extinction Training and Low-Level Laser Therapy
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2015to 4 May 2020
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Laboratory for the Study of Anxiety Disorders
Austin, Texas, 78712

Other trials in United States

About this study

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

Read the 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.

Conditions: Phobias, Claustrophobia, Social Phobia
Being tested: Extinction Training, Low-Level Laser Therapy, Sham Low-Level Laser Therapy
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
Medical subject headings: Phobic Disorders, Claustrophobia, Phobia, Social, Glossophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extinction TrainingBehavioural
Also called Exposure Therapy
Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
Low-Level Laser TherapyDevice
Also called LLLT
1064nm light used to modulate a biological function and induce a therapeutic effect.
Sham Low-Level Laser TherapyDevice
Also called Sham LLLT
Placebo dose version of LLLT.

Study groups in NCT02926352
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Sham Low-Level Laser Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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)
Change in depression symptoms from baseline to follow-up.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20154 May 2020

First posted6 Oct 2016 (estimated)
Study start1 Aug 2015
Primary completion4 May 2020
Study completion4 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PhobiasStudies of the same condition, open and under way.
More trials run by University of Texas at AustinThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02926352
Sponsor's protocol ID: 2013-12-0068
Status last verified: Dec 2022
First submitted: 28 Aug 2015
Last updated: 28 Dec 2022
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 34284836

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Low-Level Laser Stimulation With and Without Fear Extinction Training in the Modification of Pathological Fear
ClinicalTrials.gov ID: NCT02926352
Acronym / sponsor ID: 2013-12-0068
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
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: University of Texas at AustinUniversity, hospital or other
Study start: 1 Aug 2015 (actual)
Primary completion: 4 May 2020 (actual)
Study completion: 4 May 2020 (actual)
First posted: 6 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Extinction Training with LLLT	Experimental	Behavioral: Extinction Training, Device: Low-Level Laser TherapyParticipants 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 with Sham LLLT	Active comparator	Behavioral: Extinction Training, Device: Sham Low-Level Laser TherapyParticipants 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.
LLLT alone	Experimental	Device: Low-Level Laser TherapyParticipants 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.
Sham LLLT alone	Sham comparator	Device: Sham Low-Level Laser TherapyParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extinction TrainingAlso: Exposure TherapyUp to 40 min. of self-directed repeated exposure to a fear-provoking situation.	Behavioural	Extinction Training with LLLT, Extinction Training with Sham LLLT
Low-Level Laser TherapyAlso: LLLT1064nm light used to modulate a biological function and induce a therapeutic effect.	Device	Extinction Training with LLLT, LLLT alone
Sham Low-Level Laser TherapyAlso: Sham LLLTPlacebo dose version of LLLT.	Device	Extinction Training with Sham LLLT, Sham LLLT alone

Primary outcome

Behavioral Approach Test- Generalization Context
Time frame: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment)
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.

11 secondary outcomes

Behavioral Approach Test - Treatment Context
Time frame: 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)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Beck Anxiety Inventory (BAI)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Claustrophobia Questionnaire (CLQ)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Claustrophobia Concerns Questionnaire (CCQ)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Obsessive Compulsive Inventory-Revised (OCI-R)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Washing Threat Questionnaire (WTQ)
Time frame: 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)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Speech Anxiety Thoughts Inventory (SATI)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Anxiety sensitivity Index (ASI-3)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)
Body Sensations Questionnaire (BSQ)
Time frame: Baseline (Day 1; beginning of first visit); Follow-up (2 weeks, average of 14 days after treatment)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
Results publication: PubMed 34284836Zaizar 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.
Primary Outcomes Results PaperLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael J. Telch, Ph.D. principal investigator

University of Texas at Austin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Extinction Training and Low-Level Laser Therapy in people with Phobias and Claustrophobia, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavioral Approach Test- Generalization Context (time frame: Baseline (Day 1); Post-treatment (Day 1; immediately after treatment); Follow-up (2 weeks, average of 14 days after treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02926352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.