Sleep to Activate Mood Promotion- Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire-9 Depression Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Active suicidal ideation
- •Presence of mania or bipolar disorder
- •Presence of an eye disease
- •Prescription of a photosensitizing medication
- •Having previously had eye surgery
Arms & Interventions
Bright Light Intervention
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.
Intervention: Re-Timer glasses (Device)
Outcomes
Primary Outcomes
Patient Health Questionnaire-9 Depression Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: two weeks after introduction of intervention
The morningness- eveningness categories represent the time of day when a person is at their peak alertness.
Secondary Outcomes
- Actigraph Sleep Data: Minutes Asleep(daily for 4 weeks- baseline and intervention period)
- Actigraph: Number of Awakenings(daily for 4 weeks- baseline and intervention period)
- Self-Reported Sleep Diary: Night Awakenings(daily for 4 weeks- baseline and intervention period to be compared)
- Self-Reported Sleep Diary: Time at Which Participants Wake up(daily for 4 weeks- baseline and intervention period to be compared)
- Self-Reported Sleep Diary: Sleep Quality(daily for 4 weeks- baseline and intervention period to be compared)
- Fitbit Sleep Data: Night Awakenings(daily for 4 weeks- baseline and intervention period)
- Fitbit Sleep Data: Sleep Efficiency(daily for 4 weeks- baseline and intervention period)
- Self-Reported Sleep Diary: Time at Which Participants go to Bed(daily for 4 weeks- baseline and intervention period to be compared)
- Self-Reported Sleep Diary: Sleep Duration(daily for 4 weeks- baseline and intervention period to be compared)
- Actigraph: Efficiency(daily for 4 weeks- baseline and intervention period)
- Fitbit Sleep Data: Sleep Duration(daily for 4 weeks- baseline and intervention period)
Investigators
Amanda Leggett
Postdoctoral Research Fellow
University of Michigan