Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary syndrome.
详细描述
Overall Study Objective
The Bright Light Therapy Efficacy for Depressive Symptoms Following Cardiac Surgery or Acute Coronary Syndrome: Pilot Trial (BEAM-P) is a randomized controlled trial (RCT) that seeks to assess the feasibility of conducting a full trial which would assess the efficacy of Bright Light Therapy (BLT) for improving depressive symptoms post-cardiac surgery or acute coronary syndrome (ACS).
Specific Objectives
To assess the feasibility of conducting a full trial, including assessment of recruitment rate, retention rate, adherence, process time, and potential additional data values that should be measured.
Rationale
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing cardiac surgery or hospitalized for an acute coronary syndrome;
- •Age ≥ 18 years;
- •Score of ≥ 8 on the Patient Health Questionnaire-9;
- •Able to understand and to provide informed consent in English or French; and
- •Likely to be available for follow-up.
排除标准
- •Pregnant or lactating females;
- •Medical condition with a prognosis < 12 weeks;
- •History of bipolar disorder, SAD, psychosis, or dementia;
- •Medical condition contraindicating use of BLT (ocular or retinal pathology: glaucoma, cataracts, retinal detachment, retinopathy, diabetes);
- •Medical condition that increases photosensitivity (e.g. systemic lupus erythematosus, rosacea, psoriasis, albinism);
- •Current use of medication that increases photosensitivity (e.g. St John's Wort, lithium, melatonin, tetracycline, Accutane, Benzoyl peroxide, Retin-A);
- •Less than one month following previous BLT;
- •Light induced epilepsy or migraines; or
- •Suicidal ideation.
研究组 & 干预措施
Bright Light Therapy Group
Participants in this group will receive bright light therapy lamps and will be instructed to use them for 30 minutes every morning within an hour of waking up, everyday for 4 weeks.
干预措施: Bright Light Therapy Lamp (Device)
Dim Light Group
Participants in this group will receive modified dim lamps and will be instructed to use them for 30 minutes every morning within an hour of waking up, everyday for 4 weeks.
干预措施: Modified Dim Lamp (Device)
结局指标
主要结局
Recruitment rate
时间窗: Baseline
次要结局
- Retention rate(12 week follow-up period)
- Adherence rate(4 week follow-up period)
研究者
Mark Eisenberg
Professor of Medicine
McGill University