A Wearable Morning Light Treatment for Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HAM-D Total Score) at Week 5
研究概览
简要总结
This study will test a consumer health light therapy device (Re-Timer) for women with postpartum depression to better understand how it affects mood and the body clock (also called the circadian clock).
Eligible participants will be enrolled and randomized after baseline assessments. In addition to using the Re-Timer light for 5 weeks participants will complete questionnaires at various timepoints, record sleep information, wear an actigraph watch, and provide saliva samples. Additionally, the sleep of the participants' infants will also be monitored using an ankle-worn device (actigraph) and sleep diary at certain time-points as this may influence the mother's mood/sleep, and in turn affect the results.
The hypotheses regarding the bright light versus the placebo dim light of the study are:
- morning bright light therapy will produce greater improvement from pre- to post-treatment on the Hamilton Rating Scale for Depression
- morning bright light therapy will lengthen the Phase angle difference (PAD) and this will mediate change in depression symptoms.
- morning bright light therapy will produce greater improvements on self-reported depression symptoms, excessive daytime sleepiness, maternal-infant bonding, social functioning, and sleep-related impairment from pre- to post-treatment.
详细描述
Please note this project added a sub-study (HUM00235787, IRB approved on 7/31/2024) to the main study. However, the sub-study only applies to some of the participants and there are only exploratory outcomes, therefore, this will not affect the main study registration.
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, Investigator, Outcomes Assessor)
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
- •less or equal (≤) to 26 weeks postpartum
- •meet criteria for current major depressive disorder per the Structured Clinical Interview for Diagnostic (SCID) and Statistical Manual of Mental Disorders version 5 (DSM-V)
- •not currently receiving treatment for depression (for example, prescription medications or psychotherapy).
排除标准
- •Current diagnosis of Posttraumatic stress disorder (PTSD), obsessive compulsive disorder if the onset is outside of the perinatal period, eating disorder, substance abuse or dependence, lifetime history of mania/hypomania or thought disorder per SCID.
- •current diagnosis of, or high risk for, sleep-disordered breathing, insomnia disorder, restless leg syndrome, and/or narcolepsy.
- •retinal pathology or history of eye surgery
- •current use of photosensitizing medications,
- •current use of exogenous melatonin or medications that may interfere with the measurement of melatonin (nonsteroidal anti-inflammatory drugs (NSAIDs) if used daily, and beta-blockers)
- •medical conditions for which bright light therapy is contraindicated (for example, epilepsy/seizures).
- •nightshift work
- •currently pregnant
研究组 & 干预措施
Dim Light Therapy
干预措施: Dim Light Therapy (Device)
Bright Light Therapy
干预措施: Bright Light Therapy (Device)
结局指标
主要结局
Hamilton Depression Rating Scale (HAM-D Total Score) at Week 5
时间窗: Post-treatment (approximately week 5)
Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale (HAM-D) (17 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 - 52, where 0 means no depression, and 52 is the greatest possible depression. Generally, scores of 8 or higher represent clinical depression.
次要结局
- Phase Angle Difference at Week 5(Post-treatment (approximately week 5))
- Total Score on the Hamilton Depression Rating Scale-Seasonal Affective Version at Week 5 (SIGH-SAD Total Score)(Post-treatment (approximately week 5))
- Edinburgh Postnatal Depression Scale (EPDS) Total Score at Week 5(Post-treatment (approximately week 5))
- Epworth Sleepiness Scale (ESS) Total Score at Week 5(Post-treatment (approximately week 5))
- Patient Reported Outcomes Measurement Information System (PROMIS) - Satisfaction With Participation in Social Roles (SPSR) Total Score at Week 5(Post-treatment (approximately week 5))
- Patient Reported Outcomes Measurement Information System Sleep-related Impairment (SRI) Total Score(Post-treatment (approximately week 5))
- Social Functioning as Measured by the Postpartum Bonding Questionnaire (PBQ) Total Score at Week 5(Post-treatment (approximately week 5))
研究者
Leslie Swanson
Associate Professor of Psychiatry
University of Michigan