Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)

NYU Langone Health40 enrolled

Overview

This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.

This pilot study will evaluate the tolerability, usability, and preliminary impact of a novel wearable device delivering 60Hz intermittent light for treatment of depressive symptoms in adults with MDD. All procedures are conducted remotely.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Depression MDD Major Depressive Disorder Major Depressive Episode

Eligibility

Sex: ALLMin age: 24 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 24 and 65 years (inclusive)\*. * Confirmed diagnosis of Major Depressive Disorder (MDD), based on MINI interview. * Hamilton Depression Rating Scale (HDRS-17) score ≥17 at screening. * On a stable dose of antidepressant medication for at least 30 days prior to HDRS-17 screening. * No evidence of premorbid cognitive impairment, as demonstrated by a standard score \>85 on the WRAT-5 Reading Recognition Subtest. * Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms. * Able to provide informed consent and comply with study procedures. * Access to a quiet space suitable for home-based light stimulation sessions. * English speaking: All study materials and assessments are only validated in English Exclusion Criteria: * Presence of primary neurological or autoimmune disorders. * Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder). * Current or recent diagnosis of alcohol or substance use disorder. * History of bipolar disorder or any psychotic disorder. * Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS). * History of seizure disorder or epilepsy. * History of migraine, tinnitus, or photosensitivity. * Diagnosis of retinal disease, cataract, or other visual impairments that may interfere with light exposure. * Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel). * Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding

Outcomes

Primary Outcomes

Proportion of Participants who Complete all Scheduled Sessions

Measure of retention; 15 sessions scheduled in total.

Time frame: Up to Week 3

Average Percentage of Completed Sessions

Measure of adherence; 15 sessions scheduled in total.

Time frame: Up to Week 3

Proportion of Participants who Discontinue due to Adverse Effects

Measure of tolerability.

Time frame: Up to Week 3

Secondary Outcomes

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score

The MADRS is a 10-item assessment of depression; each item is rated on a 7-point scale from 0 to 6. The total score is the sum of responses and ranges from 0 to 60; higher scores indicate greater severity of depression.

Time frame: Baseline, Week 3

Change in Hamilton Depression Rating Scale (HDRS-17) Score

The HDRS-17 is a 17-item scale assessing the severity of depression. Most items are rated on a 5-point scale (0-4), with some using a 3-point scale (0-2). The total score is the sum of responses and ranges from 0-52; higher scores indicate greater severity of depression.

Time frame: Baseline, Week 3

Change in Patient Health Questionnaire (PHQ-9) Score

The PHQ-9 is a 9-item scale assessing the prevalence of depressive symptoms. Each item is rated on a 4-point Likert scale from 0 to 3. The total score is the sum of responses and ranges from 0-27; higher scores indicate greater prevalence of depressive symptoms.

Time frame: Baseline, Week 3

Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score

The QIDS-SR is a 15-item scale assessing depressive symptoms over the previous 7 days. Each item is rated on a 4-point Likert scale from 0 to 3. The total score is the sum of responses and ranges from 0-45; higher scores indicate greater prevalence of depressive symptoms.

Time frame: Baseline, Week 3

Change in Work and Social Adjustment Scale (WSAS) Score

The WSAS is a 5-item scale assessing the impact of mental health on daily activities. Each item is rated on a 9-point Likert scale from 0 to 8. The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe impairment on daily activities.

Time frame: Baseline, Week 3

Change in Generalized Anxiety Disorder (GAD-7) Score

The GAD-7 is a 7-item scale assessing the severity of generalized anxiety disorder. Each item is rated on a scale from 0 to 3. The total score is the sum of responses and ranges from 0-21 with higher scores indicating more severe anxiety.

Time frame: Baseline, Week 3

Post-Study System Usability Questionnaire (PSSUQ) Score

The PSSUQ assesses the overall usability of the intervention; each of the 16 items is rated on a scale from 1-7. The total score is the sum of responses and ranges from 16 to 112; higher scores indicate greater usability of the intervention.

Time frame: Week 3

System Usability Scale (SUS) Score

The SUS is a 10-item assessment of the usability of the intervention; the items are rated on a scale from 1-5. The total score is the sum of responses and ranges from 10 to 50; higher scores indicate greater usability of the intervention.

Time frame: Week 3

Net Promoter Score (NPS)

The NPS is a single-item questionnaire asking participants how likely they are to recommend the intervention to a colleague. The total score ranges from 1-10; higher scores indicate greater likelihood of promoting the intervention.

Time frame: Week 3

Brief Blinding Questionnaire (BBQ) Score

After completing the intervention phase of the study, effectiveness of participant blinding will be assessed using a 3-item questionnaire. The outcome will be scored as the percentage of participants who correctly guess their blinding assignment.

Time frame: Week 3

Adverse Events

Incidence of spontaneously reported adverse events during the intervention period. Incidence and type will be reported in the "Adverse Events" section of the results.

Time frame: Week 3

Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts