A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of Participants who Complete all Scheduled Sessions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active Home-Based Intermittent Light Therapy
Adults with a major depressive episode (MDE) randomized to receive active home-based 60Hz intermittent light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions.
干预措施: 60Hz Intermittent Light Therapy (Device)
Sham Home-Based Light Therapy
Adults with a major depressive episode (MDE) randomized to receive sham home-based light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions.
干预措施: Sham Light Therapy (Device)
结局指标
主要结局
Proportion of Participants who Complete all Scheduled Sessions
时间窗: Up to Week 3
Measure of retention; 15 sessions scheduled in total.
Proportion of Participants who Discontinue due to Adverse Effects
时间窗: Up to Week 3
Measure of tolerability.
Average Percentage of Completed Sessions
时间窗: Up to Week 3
Measure of adherence; 15 sessions scheduled in total.
次要结局
- Net Promoter Score (NPS)(Week 3)
- Brief Blinding Questionnaire (BBQ) Score(Week 3)
- Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score(Baseline, Week 3)
- Adverse Events(Week 3)
- Change in Work and Social Adjustment Scale (WSAS) Score(Baseline, Week 3)
- Change in Generalized Anxiety Disorder (GAD-7) Score(Baseline, Week 3)
- System Usability Scale (SUS) Score(Week 3)
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score(Baseline, Week 3)
- Change in Hamilton Depression Rating Scale (HDRS-17) Score(Baseline, Week 3)
- Change in Patient Health Questionnaire (PHQ-9) Score(Baseline, Week 3)
- Post-Study System Usability Questionnaire (PSSUQ) Score(Week 3)