A Randomized Control Trial of the Effectiveness of Blue-blocking Glasses for Mania in Inpatients With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Change in the Young Mania Rating Scale
研究概览
简要总结
Mania is a serious condition. Symptoms of mania include decreased sleep, increased energy, changes in mood, thinking, and behavior. Dark therapy, which involves placing patients in a dark room for 14 hours overnight, can effectively treat mania, but is not practical. Dark therapy is also unpleasant. However, similar effects on the brain can be created from blocking only blue light with glasses. This preserves the wearer's ability to see and move safely. A trial of blue-blocking glasses for mania in Norway produced dramatic improvements in manic symptoms within three days of hospitalization. Mania both disrupts the sleep-wake cycle and is triggered by short and interrupted sleep. Examples of triggers include shift work and travel across time zones. Therefore, mania involves the "day-night" clock in the brain. The rhythm of the brain's clock is set by special sensors in the eye that identify daytime from blue light. If light does not include this blue spectrum, this informs the brain it is nighttime. In spite of the obvious potential of blue blocking glasses for mania, there has been no confirmatory study of this simple treatment in the five years since the initial Norwegian trial. Without a second study, this treatment will not find its way into routine clinical care. The investigators will conduct a randomized controlled trial of blue-blocking glasses for mania in hospitalized patients. The investigators will also assess activity, sleep, and saliva melatonin (a hormone secreted in the brain at night) to see how this treatment works. If our trial confirms that blue-blocking glasses are effective, this treatment could help those suffering with mania return to their life more quickly. Medications for mania can also cause serious side-effects and having glasses as a treatment option might also reduce the amount of medicine needed to get well. Blue-blocking glasses could be a low-cost non-medication treatment. The investigators will look at how they could put this treatment into practice as part of everyday care.
详细描述
The purpose of this research project is to determine the effectiveness of blue-blocking glasses as adjunctive treatment for mania in bipolar disorder, assess circadian mechanisms, and provide information to improve translation to real-world practice settings. The investigators propose to conduct a confirmatory and more definitive clinical trial of blue-blocking glasses for mania and explore the putative role of circadian factors in mechanisms of action.
The primary objective is to specifically determine whether blue-blocking glasses are effective at reducing manic symptoms in inpatients beyond any general reduction in light exposure. This represents an advance on prior study, which compared them to clear lenses. For reasons outlined in the background, the investigators hypothesis that adding blue-blocking glasses to pharmacological treatment as usual for mania will improve symptoms, as measured by the clinician administered rating scales.
The secondary objectives relate to understanding how the reduction in manic symptoms with blue blocking glasses corresponds to changes in circadian rhythms. Not all patient with mania will be able to participate in this portion of the protocol (relevant to Aim 2 below) and it will subsequently be performed in a subset of patients, who are both capable and interested in adhering to the protocol, and at sites able to implement. At this time, the investigators anticipate this portion of the protocol being administered at the two campuses of The Ottawa Hospital. The investigators hypothesize that changes in circadian rhythms will be correlated to improvement in manic symptoms and thus a likely mechanisms of action.
The investigators also plan to conduct qualitative interviews to inform future implementation of this or related interventions (Aim 3).
Aim 1 (Effectiveness): To compare the effectiveness (change in Young Mania Rating Scale) of blue-blocking glasses to lightly tinted glasses as an adjunctive therapy with treatment as usual for psychiatric inpatients with mania.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will be informed that the investigators are studying the effects of two different types of light filters without more detail so they will not know which is the experimental vs. control condition. With possible un-blinding from other sources of information and lens color, the investigators will assess the integrity of the blind by asking participants whether they thought they received the experimental or the control glasses at the end of the study. Participates will also be encouraged not to share details of their glasses assignment with other participants and physicians to avoid unblinding.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 to 70 years of age
- •Have a Diagnostic and Statistical Manual of Mental Disorders (5th Edition) defined manic symptoms that persist beyond the physiological effects of a substance
- •Be willing to have investigators obtain information from the treatment team and electronic medical record
- •Participants must be able to read and understand English or French.
- •Be willing and able to provide informed consent.
- •(Sub-study only): Meet the safety specifications for the devices in the sub-study, according to their user manuals
排除标准
- •Have severe eye disease or trauma
- •Have a history of traumatic brain injury.
- •Have sleep apnea
- •(Sub-study only): Have current exogenous melatonin intake
结局指标
主要结局
Change in the Young Mania Rating Scale
时间窗: Baseline to Week 2 (End of Study)
The Young Mania Rating Scale is used to evaluate the severity of manic symptoms at baseline and over time in individuals with mania. It is an 11-item scale and total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). We will model differences between groups in the primary outcome using linear mixed models (group by time interaction) including a random intercept term for participant.
次要结局
- Amount of antipsychotic (in chlorpromazine equivalents) and benzodiazepine used (in lorazepam equivalents)(Baseline to Week Two (End of Study))
- Change in the Patient Mania Questionnaire - 9-Item Scale for Assessing and Monitoring Manic Symptoms (PMQ-9)(Baseline; Week One; Two Week (End of Study))
- Change in the Patient Health Questionnaire - 9-Item Measuring the Severity of Depression Symptoms (PHQ-9)(Baseline; Week One; Two Week (End of Study))
- Change in the Digital Self-Report Survey of Mood for Bipolar Disorder - 6-Item Digital Survey Measuring Mood Changes in Bipolar Disorder (digiBP)(Baseline; Week One; Two Week (End of Study))
- Change in the General Anxiety Disorder Questionnaire- 7-Item Measuring Severity of Anxiety Symptoms (GAD-7)(Baseline; Week One; Two Week (End of Study))
- Change in Altman Self-Rating Mania Scale - 5-Item Self Rating Mania Scale (ASRM)(Baseline; Week One; Two Week (End of Study))
- Change in the Hamilton Depression Rating Scale - 21-Item for the Assessment of Depression Severity (HAM-D)(Baseline; Day 1-2; Day 3-5; Week One; Day 9-10; Day 11-12; Week Two (End of Study))
- Total number of medications needed(Baseline to Week Two (End of Study))
- Differences in sleep efficiency as estimated from actigraphy(Baseline to Two Weeks (End of Study))
- Change in The Morning Evening Questionnaire - 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)(Baseline; Week One; Two Week (End of Study))
- Change in The Pittsburgh Sleep Quality Index - 18-Item Self-Assessment to Evaluate Sleep Quality (PSQI)(Baseline; Week One; Two Week (End of Study))
- Change Circadian Rhythms(Inferred from melatonin/cortisol curves, rest-activity cycle (wrist actigraphy), heart rate/temperature monitoring, Electroencephalography)
- Change in The Leeds Sleep Evaluation Questionnaire - 10-Item Self-Rating Scale of Sleep Behavior (LEEDS)(Baseline; Week One; Two Week (End of Study))
- Change in the Pre-Sleep Arousal Scale - 16-Item Self-Rated Scale of Symptoms of Arousal at Bedtime (PSAS)(Baseline; Week One; Two Week (End of Study))