The LIGHT-60 Trial - Light Intervention for Geriatric Patients Hospitalized for Depression Treatment
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Study completion rate
研究概览
简要总结
Bright light therapy has been shown to be effective for the treatment of both seasonal and non-seasonal unipolar depression as well as bipolar depression, primarily in outpatients under the age of 60. There is a dearth of studies exploring the efficacy of this treatment modality among elderly depressed inpatients, which is our study population.
详细描述
Investigators are studying the ability of light therapy to reduce depressive symptoms in elderly patients who are hospitalized with unipolar depression (depression that is not due to bipolar disorder). Participants will receive either active light treatment or inactive treatment (also known as placebo).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A current episode of non-psychotic unipolar depression as the primary reason for psychiatric hospitalization
- •Currently hospitalized on the MUSC Senior Care Unit
- •Age 60 years or older
- •HAMD-17 ≥8
排除标准
- •Any prior use of bright light therapy
- •Primary indication for hospitalization is for a disorder other than major depressive disorder (determined by patient's treatment team)
- •Photosensitive medical conditions or current use of photosensitizing medications - if patients have been advised by a treating clinician at any point to avoid sunlight because of their current medication regimen or medical condition, they will be considered to have a photosensitive medical condition and will be excluded from this study.
- •Treatment with ECT; if a patient's condition deteriorates during study participation such that the treatment team feels ECT would be in their best interest, they will be withdrawn from study participation. For logistical and transport purposes, the study team feels that exclusion of patients receiving ECT will be necessarily. Additionally, these patients would likely be excluded from a future larger RCT given that ECT would likely interfere with signal of BLT efficacy.
- •Uncontrolled headaches or any migraines within the last month
- •Major neurocognitive disorder
- •Severe intellectual disability
- •Inability to consent for the study
- •Active psychosis
研究组 & 干预措施
Bright light therapy
Participants in the intervention group will receive bright light therapy (BLT) consisting of 10,000 lux of bright white light administered for 30 minutes each morning, ideally within 30 minutes of awakening. Participants in both arms will continue to receive other treatment as usual (group therapy and medication management) as deemed appropriate by their treating clinicians.
干预措施: Bright light therapy (Device)
Dim Red light
Participants in the control group will receive a placebo condition using an identical light box fitted with a translucent red screen to emit dim red light at an intensity of less than 2,500 lux, which lacks efficacy for depression treatment based on prior research. Participants in both arms will continue to receive other treatment as usual (group therapy and medication management) as deemed appropriate by their treating clinicians.
干预措施: dim red light (Device)
结局指标
主要结局
Study completion rate
时间窗: Up to week 6 (Upon time of discharge from inpatient unit)
Percentage of patients who complete the study while psychiatrically hospitalized
Adequacy of allocation blinding
时间窗: Up to week 6 (Upon time of discharge from inpatient unit)
assessed by the proportion of participants who correctly identify their study arm allocation. Blinding will be considered adequate if the proportion of correct guesses does not significantly exceed chance levels
次要结局
- Preliminary efficacy data - Mean change in Hamilton Depression Rating Scale 17 item scale (HAMD-17)(Day of enrollment, week 1, week 2, week 4, week 6)
- Preliminary efficacy data - Mean change in Beck Depression Inventory II (BDI-II) Score(Day of enrollment, week 1, week 2, week 4, week 6)
研究者
Benjamin Kalivas
Associate Professor-Faculty
Medical University of South Carolina