Chronobiological Basis of Depression During the Menopause Transition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Urine-based 6-sulfatoxymelatonin (6-SMT)
研究概览
简要总结
**Participants must live in San Diego County**
The purpose of this study is to learn more about an experimental Sleep & Light Intervention (SALI) for menopausal mood changes or depression. Researchers want to find out whether adjusting the body's internal clock-which helps regulate sleep, hormones, mood, and energy- can improve symptoms such as depression, poor sleep, and low energy during menopause.
详细描述
Our bodies naturally follow a 24-hour internal clock that helps regulate sleep, hormones, mood, and energy. During menopause, hormonal changes can disrupt the timing of this internal clock, which may contribute to mood changes, sleep problems, and low energy.
Participants will be asked to change their sleep timing for one night and use bright light at specific times of day for two weeks. In previous studies, some women experienced improvements in mood within days to weeks. SALI does not use medication and has few side effects.
Participants must live in San Diego County. Interested individuals will first complete a screening process to help determine whether this study is a good match for them and whether participation would be appropriate and safe. The screening includes questionnaires and interviews about health, mood, sleep, and mental health history. Not everyone who is screened will qualify to participate.
Study participation is approximately 4 ½ months, and includes:
- 4 weeks of wearing an activity/light wrist sensor
- 2 overnight urine collections to measure melatonin, the best measure of human circadian rhythms, and a hormone that helps regulate the timing of sleep
- 1 night where the timing and duration of your sleep will be adjusted
- 2 weeks of daily light box usage (30 minutes per day at a specified time) and daily surveys to track mood & side effects
- Regularly scheduled Zoom interviews & online surveys to monitor your mood & sleep before and after SALI
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 45-75 years old
- •Experiencing significant down, sad or hopeless feelings that are affecting their daily life
- •These mood changes started or got worse during the menopause transition
- •Irregular or no menstrual cycle for at least 6 months
- •Non-smoking
- •Located in San Diego County
排除标准
- •Untreated sleep apnea
- •Migraine headaches that are triggered or worsened by bright light
- •Currently suicidal or psychotic
- •History of bipolar disorder
- •A medical condition or job where fatigue or changes in sleep schedule could be unsafe
- •Planning to start, stop, or change medications in the next 4 months
研究组 & 干预措施
Group 1
Participants assigned to the experimental condition.
干预措施: Phase Advanced Intervention (PAI) (Behavioral)
Group 2
Participants assigned to the active comparator condition.
干预措施: Phase Delay Intervention (PDI) (Behavioral)
结局指标
主要结局
Urine-based 6-sulfatoxymelatonin (6-SMT)
时间窗: Baseline and after completing two-week intervention.
Change in melatonin onset, offset, and acrophase.
Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS)
时间窗: Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.
Clinicians rate change in mood on a numerical scale where 0= little/no symptoms and a higher number indicates increased symptoms or impairment.
Patient Health Questionnaire (PHQ-9)
时间窗: Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.
PHQ-9 assesses mood. Participants rate items on a scale of 0 to 3, where 0 = Not at all; 1 = Several days; 2 = More than half the days; 3 = Nearly every day.
Sleep Quality Rating (SQR)
时间窗: Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.
Participants will rate their sleep quality as well as whether they feel rested and alert using a slider scale. For this scale, lower value indicates better scores while higher values indicate worse scores.
Objective Measures of Sleep
时间窗: Continuous monitoring from one week prior to baseline through one week post intervention completion.
Change in sleep timing and duration (objectively measured via continuously worn MotionWatch device)
Objective Measures of Physical Activity
时间窗: Continuous monitoring from one week prior to baseline through one week post intervention completion.
Change in physical activity (objectively measured via continuously worn MotionWatch device)
Urinary 6-sulfatoxymelatonin (6-SMT)
时间窗: Urine is collected at baseline and after completing two-week intervention.
Collected to measure melatonin, a hormone that helps regulate your sleep and body clocks.
Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS)
时间窗: Completed at baseline and after completing two-week intervention.
A clinician-conducted interview that asks about symptoms of depression, including mood, sleep, appetite, energy, and other emotional and physical symptoms.
Patient Health Questionnaire (PHQ-9)
时间窗: Completed at baseline and after completing two-week intervention.
A brief questionnaire that asks about common symptoms of depression, such as mood, sleep, energy, appetite, and concentration.
Sleep Quality Rating (SQR)
时间窗: Completed at baseline and after completing two-week intervention.
A brief questionnaire to rate how well you have been sleeping and whether you have experienced any sleep-related problems.
次要结局
未报告次要终点
研究者
Barbara L. Parry, M.D.
Professor of Psychiatry
University of California, San Diego