Transcranial Photobiomodulation in Anxiety Disorders
ConditionSymptoms of Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorFrancisco Gonzalez-Lima, PhD
About this trial
The investigators have previously shown that safe, non-invasive methods of brain stimulation such as the administration of transcranial infrared light can result in improvements to cognition and emotion. The investigators hypothesize that transcranial photobiomodulation (tPBM) can be used in conjunction with attention bias assessment and modification to reduce anxiety symptoms in individuals with sub-clinical anxiety.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years of age and older
State-Trait Anxiety Index (STAI) questionnaire score between 40-59 (indicates moderate sub-clinical anxiety)
Patient Health Questionnaire (PHQ-9) score between 1-9 (indicates minimal to mild sub-clinical depression)
Disqualifiers
STAI score less than 40 or greater than 59
PHQ-9 score greater than 9
Medication instability (i.e., medication change within 6 weeks)
Indicated suicidal ideation
Trial design
Design model
Parallel
Treatments tested in this trial
Attention bias assessment and modification
BehavioralAttention bias assessment and modification involve two versions of the dot-probe task. These tasks are based on the premise that repeated attention shifts can retrain attentional biases, with the expectation that reducing attentional bias toward threats will alleviate sub-clinical anxiety symptoms.
Transcranial photobiomodulation
DeviceParticipants will receive near-infrared light at 1064 nanometers to the right side of the forehead for 8 minutes. The investigators have introduced this form of transcranial photobiomodulation (tPBM) as a means of human cognitive enhancement, and as an adjunct for attention bias modification for the reduction of symptoms of depression. In the present study, the investigators wish to extend these findings to the use of attention bias modification for the reduction of sub-clinical anxiety.
Treatment groups
280 Participants
are divided into 4 treatment groupsGroup A: Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM)Active comparator 2 interventions
Group B: Arm 2: attention bias assessment (ABA), sham tPBMSham comparator 1 intervention
Group C: Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM)Active comparator 2 interventions
Group D: Arm 4: attention bias assessment and modification (ABA/ABM), sham tPBMSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite cognitive score in the dot-probe task
The participant pays attention to a fixation cross in the center of the screen, which is followed by the presentation of two images on the left and right of the screen. One of these new images is a "threat" image, while the other is neutral. Following each trial of stimuli presentation, a probe type ("\<" vs. "\>") will randomly appear in the same location previously occupied by either the threatening or neutral image and remain on the screen until the participant has responded. Participants respond to the probe type by pressing the "←" or the "→" arrow key, respectively, on the keyboard, as quickly but as accurately as possible. The probe randomly replaces the neutral or the negative stimulus with equal frequency (50/50). The single primary outcome is the composite cognitive score which is calculated on the basis of performance in this task.
Time frame
Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)2
Change in concentration of oxygenated hemoglobin as measured by functional near-infrared spectroscopy
Hemodynamic activity is assessed non-invasively using near-infrared spectroscopy. In this procedure, a participant wears an apparatus on the head which contains an array of light sources and detectors. Light is applied to the surface of the skin, and a small fraction of the light passes through the underlying tissue and reflects back to the surface, where it is detected and the number of photons at specific light wavelengths are counted by a computer. This photon count can be converted to changes in concentration of metabolic indices, such as oxygenated/deoxygenated hemoglobin.
Time frame
Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Francisco Gonzalez-Lima, PhD
Lead sponsor
University of Texas at Austin
Sponsor institution
Source ClinicalTrials.gov