Sleep to Activate Mood Promotion- Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Insomnia Severity Index Sum Scores
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
Outcomes
Primary Outcomes
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.
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.
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