Sleep to Activate Mood Promotion
- Conditions
- DepressionSleep Quality
- Interventions
- Device: Re-Timer glasses
- Registration Number
- NCT02413294
- Lead Sponsor
- University of Michigan
- Brief Summary
The investigators are aiming to examine the acceptability and feasibility of a portable bright light therapy instrument to improve sleep disturbance in a preventive intervention for depression. The investigators will conduct an intervention that trials the use of bright light glasses called "re-timers" as a preventive intervention in older adults with sleep disturbance and subsyndromal symptoms of depression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 65 years of age or older
- 6 or greater on the Pittsburgh Sleep Quality Index
- A score of 5 to 9 on the Patient Health Questionnaire-9 Depression Scale
- Active suicidal ideation
- Presence of mania or bipolar disorder
- Presence of an eye disease
- Prescription of a photosensitizing medication
- Having previously had eye surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bright Light Intervention Re-Timer glasses Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals' baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.
- Primary Outcome Measures
Name Time Method Patient Health Questionnaire-9 Depression Scale two weeks after introduction of intervention The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.
Insomnia Severity Index Sum Scores two weeks after introduction of intervention The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28. A score of 15 or higher is indicative of clinical insomnia.
Pittsburgh Sleep Quality Index two weeks after introduction of intervention The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.
Morningness-Eveningness Questionnaire two weeks after introduction of intervention The morningness- eveningness categories represent the time of day when a person is at their peak alertness.
- Secondary Outcome Measures
Name Time Method Actigraph Sleep Data: Minutes Asleep daily for 4 weeks- baseline and intervention period mean nightly sleep duration for each of the two-week periods: baseline and intervention
Actigraph: Number of Awakenings daily for 4 weeks- baseline and intervention period Actigraphy counts awakenings by using an accelerometer to assess motion during the night. The number of awakenings is the mean nightly number of awakenings during each of the two-week periods: baseline and intervention.
Self-Reported Sleep Diary: Night Awakenings daily for 4 weeks- baseline and intervention period to be compared mean number of night awakenings per person per night as reported in sleep diaries
Self-Reported Sleep Diary: Time at Which Participants Wake up daily for 4 weeks- baseline and intervention period to be compared Wake time represents the moment in time at which participants awaken. Time between actual hours is calculated on a decimal basis so an additional 6 minutes = .1. so that 7.5 represents 7:30 a.m. and 7.8 represents 7:48 a.m.
Self-Reported Sleep Diary: Sleep Quality daily for 4 weeks- baseline and intervention period to be compared sleep quality is a participants' mean self-report for each of the two week periods: baseline and intervention. Sleep quality is reported for each night on a scale of 0 (very poor) to 4 (very good).
Fitbit Sleep Data: Night Awakenings daily for 4 weeks- baseline and intervention period mean nightly awakenings for each of the two week periods: baseline and intervention. Similar to the actigraph the Fitbit counts awakenings through an accelerometer which measures motion.
Fitbit Sleep Data: Sleep Efficiency daily for 4 weeks- baseline and intervention period Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).
Self-Reported Sleep Diary: Time at Which Participants go to Bed daily for 4 weeks- baseline and intervention period to be compared Bed time represents the moment in time at which participants went to bed, measured on a revised clock where 6pm = 18, Midnight = 24 and 6am =30. Time between actual hours is calculated on a decimal basis, so an additional 6 minutes = .1. This revised clock is necessary in order to make means work properly in the nighttime hours. Otherwise, averaging between a 10pm bedtime and a 2am bedtime would give the impossible, inaccurate mean of being in the daytime between those two numbers.
Self-Reported Sleep Diary: Sleep Duration daily for 4 weeks- baseline and intervention period to be compared nightly mean of length of sleep measured in minutes
Actigraph: Efficiency daily for 4 weeks- baseline and intervention period Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100). The mean for each of the two-week periods: baseline and intervention, is calculated.
Fitbit Sleep Data: Sleep Duration daily for 4 weeks- baseline and intervention period mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States