Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02926352
Other study ID # 2013-12-0068
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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)
See also
  Status Clinical Trial Phase
Completed NCT02256566 - Cognitive Training for Mood and Anxiety Disorders N/A
Completed NCT01570400 - Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT N/A
Recruiting NCT01388231 - Transfer of Manualized Cognitive-Behavioral Therapy (CBT) for Social Phobia Into Clinical Practice Phase 2/Phase 3
Completed NCT00684541 - Interpretation Modification Program for Social Phobia N/A
Completed NCT00434759 - Social Phobia Intervention Study of Mannheim N/A
Completed NCT00380731 - Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia N/A
Completed NCT03647605 - Pilot Study: VR Mind and VR Mind+ Intervention N/A
Not yet recruiting NCT03241277 - Nonsurgical Periodontal Treatment in Patients With Social Phobia N/A
Completed NCT02648737 - Cognitive Behavioural Therapy for Anxiety Disorders in PD N/A
Completed NCT02294409 - Manualized Group Cognitive-behavioral Therapy for Social Anxiety in First Episode Psychosis N/A
Terminated NCT01979263 - Attention Bias Modification Treatment for Anxious Youth N/A
Completed NCT01463137 - Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder N/A
Completed NCT00774150 - Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study N/A
Completed NCT00264654 - Long-term Study Of Paroxetine in Women and Men Phase 3
Completed NCT00326430 - Residential Cognitive and Interpersonal Therapy for Social Phobia Phase 2/Phase 3
Completed NCT00000389 - Treatment for Anxiety in Children Phase 3
Completed NCT00397722 - Treatment Of Patients With Social Anxiety Disorder Phase 2
Completed NCT02678624 - Project Collabri for Treatment of Anxiety N/A
Completed NCT00564967 - A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy Phase 3
Completed NCT00403962 - A Combination Therapy In Patients With Social Anxiety Disorder Phase 2

External Links