Pilot Sleep Extension and Mood

NCT06675799 | Completed

• 1 other identifier: 2024-1230
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Internalizing Mental Health Symptoms; Sleep Problems

Keywords

young adults; sleep; mood; anxiety; depression; sleep extension; stress

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Daytime fatigue

  From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)

• Bedtime Procrastination

  From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)

• Electronics use before bed

  Pre-treatment and at 6-week post-treatment assessment

Study Arms (2)

Sleep Extension

EXPERIMENTAL

Sleep-related psychoeducation will be provided in weekly lesson content. Phone coaching will revolve around sleep health and meeting sleep goals.

Behavioral: Sleep Extension

Healthy Living

ACTIVE COMPARATOR

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

Interventions

Sleep Extension BEHAVIORAL

Weekly educational material about sleep health and weekly brief phone coaching calls for a total of 6 weeks.

Sleep Extension

Healthy Living Psychoeducation BEHAVIORAL

Weekly educational materials about healthy habits and weekly brief phone calls to clarify terms or concepts.

Healthy Living

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Parasomnias; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jennifer Duffecy, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 5, 2024
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: November 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-02

Locations

US (1)