Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction (SALI)

August 3, 2026 updated by: Barbara L. Parry, M.D., University of California, San Diego

Chronobiological Basis of Depression During the Menopause Transition

**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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Recruiting
        • University of California San Diego Hillcrest Medical Center
        • Contact:
        • Principal Investigator:
          • Barbara L Parry, M.D.
        • Contact:
          • Barbara L Parry, M.D.
          • Phone Number: (619) 980-1942
          • Email: bparry@ucsd.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Participants assigned to the experimental condition.
Behavioral: Phase 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.
Active Comparator: Group 2
Participants assigned to the active comparator condition.
Behavioral: Phase 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary 6-sulfatoxymelatonin (6-SMT)
Time Frame: 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.
Urine is collected at baseline and after completing two-week intervention.
Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS)
Time Frame: 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.
Completed at baseline and after completing two-week intervention.
Patient Health Questionnaire (PHQ-9)
Time Frame: 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.
Completed at baseline and after completing two-week intervention.
Sleep Quality Rating (SQR)
Time Frame: 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.
Completed at baseline and after completing two-week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Barbara Parry, M.D., University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH134120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to directly share individual participant data (IPD) with other investigators. If such data is requested, the investigators will consider each request individually to determine whether sharing of IPD is appropriate or feasible. However, the investigators will be providing de-identified data to the National Institution for Mental Health Data Archive (NDA) throughout the duration of the study as required by NIH. This data will be available to other investigators after the conclusion of the study per the guidelines and restrictions established by the NDA.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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