A Feasibility Study of Adherence to Light Therapy for Maintenance Treatment of Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Adherence Rate
研究概览
简要总结
In this feasibility study, we propose an important question: What factors will affect participant adherence to the daily use of light therapy for maintenance treatment of depression? To answer this question, we will conduct a pilot study of open-label treatment with light therapy in a small sample (n=10) of participants meeting eligibility criteria to determine what factors will challenge or enhance adherence to a standard light therapy protocol.
详细描述
Guidelines recommend at least 6-9 months of maintenance treatment to prevent relapse once patients with major depressive disorder (MDD) are in symptom remission with antidepressant treatment. However, many patients decide to discontinue antidepressants because of side effects or personal preference for a non-pharmacological treatment. Hence, a priority question for patients is whether non-pharmacological treatments can be substituted for antidepressants for maintenance treatment.
Light therapy is a safe, evidence-based, non-pharmacological treatment for MDD and seasonal affective disorder (SAD) with fewer side effects than antidepressants. The safety and efficacy of light therapy suggest that it would also be effective for maintenance treatment and relapse prevention, but there are no studies addressing this question.
Before conducting a randomized controlled trial, we want to determine whether light therapy is feasible for patients in remission with antidepressants and whether patients will adhere to standard light therapy protocols. In this feasibility study, we will enroll patients with MDD in remission who wish to discontinue their antidepressant and substitute open-label light therapy to examine adherence outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[1] Outpatients 19 to 65 years of age;
- •[2] Diagnostic and Statistical Manual (DSM)-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview;
- •[3] taking an antidepressant for no more than six months;
- •[4] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;
- •[5] total score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale [MADRS];
- •[6] Willing and able to complete self-report and online assessments including sufficient fluency in English.
排除标准
- •[1] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime);
- •[2] MDD with psychotic features (lifetime);
- •[3] significant personality disorder diagnosis [e.g., borderline, antisocial];
- •[4] High suicidal risk, defined by clinician judgment;
- •[5] History of drug or alcohol abuse, with a severity of at least moderate or severe within 6 months before screening;
- •[6] Significant neurological disorders, head trauma, or other unstable medical conditions;
- •[7] regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers);
- •[8] history of severe withdrawal effects with antidepressant discontinuation;
- •[9] retinal disease or other eye condition preventing use of bright light therapy;
- •[10] use of photosensitizing medication within 1 week of baseline visit.
研究组 & 干预措施
Light therapy
Daily exposure on weekdays to a standard light device (e.g., fluorescent light box such as the Carex Day-Light Classic, emitting 4000 Kelvin white light rated at 10,000 lux at 14 inches from screen to cornea, with an ultraviolet filter) for 30 minutes as soon as possible after awakening, preferably between 7:00-8:00 am. Participants will also taper and discontinue their antidepressant medication.
干预措施: Light therapy (Device)
结局指标
主要结局
Adherence Rate
时间窗: 6 weeks
Rate of adherence (\>75% of total daily sessions) to light therapy
次要结局
- Relapse Rate(6 weeks)
- Change in Clinician-rated Depressive Symptoms(6 weeks)
- Discontinuation Symptoms(4 weeks)
- Change in Patient-rated Depressive Symptoms(6 weeks)
研究者
Raymond Lam
Professor
University of British Columbia