The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks
研究概览
简要总结
The proposed study aims to establish the feasibility of light therapy for postpartum depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Within 6 months postpartum
- •Meet DSM-V diagnostic criteria for MDD
- •Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD).
排除标准
- •current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V
- •past history of mania/hypomania,
- •chronic medical conditions associated with depression (e.g., thyroid conditions)
- •ocular or retinal pathology
- •history of seizures or epilepsy
- •color blindness
- •currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).
结局指标
主要结局
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks
时间窗: After five weeks of light therapy
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin
Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks
时间窗: After five weeks of light therapy
Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) (29 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 -73, where 0 means no depression, and 73 is the greatest possible depression. Generally scores of 20 or higher represent clinical depression
Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks
时间窗: After five weeks of light therapy
Self-report of depression symptoms. The Edinburgh Postnatal Depression scale is scored from 0 to 30 where 0 is no depression and 30 is most severe depression.
次要结局
未报告次要终点
研究者
Leslie Swanson
Assistant Professor
University of Michigan