Depression, Depression During the Menopausal Transition, Menopausal Depression
Conditions
Keywords
Menopause, depression, sleep and light intervention, melatonin, circadian rhythm, Chronobiology
Brief summary
\*\*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.
Detailed description
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 All study activities can be done from the comfort of your home. Researchers hope this work will lead to new ways to improve mood and sleep during menopause and help identify treatments that can be tailored to each person's biological rhythms. This is a research study, not a clinical treatment. Participation is confidential and voluntary. Participants may or may not benefit directly from participating. To receive full compensation, participants are required to complete study tasks on scheduled days.
Interventions
BEHAVIORALPhase Advanced Intervention (PAI)
Phase-advanced restricted sleep (i.e., sleep 9pm-1am only) for 1 night, followed by morning bright white light for 30 min/day for 2 weeks.
BEHAVIORALPhase Delay Intervention (PDI)
Phase-delayed restricted sleep (i.e., sleep 3am to 7am only) for 1 night, followed by evening bright white light for 30 min/day for 2 weeks.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary 6-sulfatoxymelatonin (6-SMT) | 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) | 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) | 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) | 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. |
Countries
United States
Contacts
CONTACTJennifer A Perrott, MSW
CONTACTDavid Sommerfeld, Ph.D.
PRINCIPAL_INVESTIGATORBarbara Parry, M.D.
University of California, San Diego
Outcome results
None listed