Pilot Sleep Extension and Mood

Sleep Extension to Improve Mood in Young Urban Adults

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

Study Overview

• Status: Completed
• Conditions: Sleep Problems; Internalizing Mental Health Symptoms
• Intervention / Treatment: Behavioral: Sleep Extension; Behavioral: Healthy Living Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Extension; Sleep-related psychoeducation will be provided in weekly lesson content. Phone coaching will revolve around sleep health and meeting sleep goals.	Behavioral: Sleep Extension; Weekly educational material about sleep health and weekly brief phone coaching calls for a total of 6 weeks.
Active Comparator: Healthy Living; Psychoeducation about general health (e.g., hand washing) will be provided in weekly lesson content. Phone coaches will not provide counseling or goal setting but may clarify terms or concepts.	Behavioral: Healthy Living Psychoeducation; Weekly educational materials about healthy habits and weekly brief phone calls to clarify terms or concepts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Measured by the number of participants approached, recruited and retained	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Tolerability	Measured by sessions completed	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Acceptability	Acceptability of Intervention Measure	At end of 6-week intervention
Sleep duration	Measured by Fitbit	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Sleep efficiency	Measured by Fitbit	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Waking after sleep onset (WASO)	Measured by Fitbit	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Subjective sleep quality	Measured with the Pittsburgh Sleep Quality Index (PSQI), where higher scores indicate poorer sleep quality.	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Internalizing symptoms	Anxiety, depression, and stress as measured with the Depression, Anxiety and Stress Scale - 21 item (DASS-21), where higher scores mean more distress.	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime fatigue	PROMS-Fatigue 8 item	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Bedtime Procrastination	Bedtime Procrastination Scale where higher scores equal more procrastination.	From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Electronics use before bed	2 items taken from National Sleep Foundation 2011 Sleep in America survey	Pre-treatment and at 6-week post-treatment assessment

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Jennifer Duffecy, PhD, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: sleep; depression; anxiety; stress; young adults; mood; sleep extension
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Behavior; Anxiety Disorders; Parasomnias; Depression
• Other Study ID Numbers: 2024-1230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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