Pilot Sleep Extension and Mood
- Conditions
- Internalizing Mental Health SymptomsSleep Problems
- Registration Number
- NCT06675799
- Lead Sponsor
- University of Illinois at Chicago
- Brief Summary
The goal of this interventional study is to learn if a digital sleep extension intervention can improve sleep and mood in young urban adults with mood symptoms. The main questions it aims to answer are:
Will this intervention improve sleep? Will this intervention improve mood? Does the effect of this intervention change based on environmental factors like noise and light pollution?
Researchers will compare participants receiving the sleep intervention to participants receiving a "general healthy living" intervention to see if outcome are different across groups.
Participants will:
* receive 6 weeks of brief once weekly telephone coaching and read once weekly educational content
* have their sleep monitored daily with a FitBit and Somnofy sleep device and during the 6-week intervention period
* respond to questionnaires at the start of the intervention, halfway through the intervention, at the end of the intervention, and finally 4 weeks after completing the intervention
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- Age 18 to 30
- Have internalizing symptoms (e.g., depression, anxiety, stress)
- Have sleep concerns
- Sleep less than 7 hours per night
- Have perceived neighborhood disorder
- Smart phone that can run Somnofy app
- Access to Wifi in their home
- High risk for obstructive sleep apnea
- Significant medical morbidities or psychiatric problem, or chronic substance use
- Non-English speaking (unable to participate in therapy or questionnaire)
- Taking medications for sleep
- An insomnia disorder
- Traveling for 2 weeks or more during the 10-week study period (due to loss of data from participants not sleeping in their home where the Somnofy device has been set up)
- Employed with rotating shift or night work
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Internalizing symptoms From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) Anxiety, depression, and stress as measured with the Depression, Anxiety and Stress Scale - 21 item (DASS-21), where higher scores mean more distress.
Feasibility From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) Measured by the number of participants approached, recruited and retained
Tolerability From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) Measured by sessions completed
Acceptability At end of 6-week intervention Acceptability of Intervention Measure
Sleep duration From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) Measured by Fitbit
Sleep efficiency From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) Measured by Fitbit
Waking after sleep onset (WASO) From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) Measured by Fitbit
Subjective sleep quality From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) Measured with the Pittsburgh Sleep Quality Index (PSQI), where higher scores indicate poorer sleep quality.
- Secondary Outcome Measures
Name Time Method Bedtime Procrastination From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) Bedtime Procrastination Scale where higher scores equal more procrastination.
Electronics use before bed Pre-treatment and at 6-week post-treatment assessment 2 items taken from National Sleep Foundation 2011 Sleep in America survey
Daytime fatigue From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention) PROMS-Fatigue 8 item
Trial Locations
- Locations (1)
University of Illinois Chicago
🇺🇸Chicago, Illinois, United States