Internalizing Mental Health SymptomsNCT06675799
Pilot Sleep Extension and Mood
A study testing Sleep Extension and Healthy Living Psychoeducation in people with Internalizing Mental Health Symptoms and Sleep Problems, run by University of Illinois at Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Internalizing Mental Health Symptoms, Sleep Problems
- What is being tested?
- Sleep Extension and Healthy Living Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
Official title: 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?
Read more
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
- Being tested
- Sleep Extension, Healthy Living Psychoeducation
- Keywords
- young adults, sleep, mood, anxiety, depression, sleep extension, stress
- Medical subject headings
- Parasomnias, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ExtensionBehavioural
Weekly educational material about sleep health and weekly brief phone coaching calls for a total of 6 weeks.
Healthy Living PsychoeducationBehavioural
Weekly educational materials about healthy habits and weekly brief phone calls to clarify terms or concepts.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Extension | Experimental | Sleep-related psychoeducation will be provided in weekly lesson content. Phone coaching will revolve around sleep health and meeting sleep goals. Receives: 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. Receives: Behavioral: Healthy Living Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Measured by the number of participants approached, recruited and retained
Measured: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Tolerability
Measured by sessions completed
Measured: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Acceptability
Acceptability of Intervention Measure
Measured: At end of 6-week intervention
Sleep duration
Measured by Fitbit
Measured: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Sleep efficiency
Measured by Fitbit
Measured: 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
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Secondary outcomes (3)
Daytime fatigue
PROMS-Fatigue 8 item
Measured: 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.
Measured: 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
Measured: Pre-treatment and at 6-week post-treatment assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Jan 2025
- Primary completion30 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internalizing Mental Health SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Duffecy, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675799
- Sponsor's protocol ID
- 2024-1230
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Extension to Improve Mood in Young Urban Adults
- ClinicalTrials.gov ID
- NCT06675799
- Acronym / sponsor ID
- 2024-1230
- Keywords
- young adults, sleep, mood, anxiety, depression, sleep extension, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Extension | Experimental | Behavioral: Sleep ExtensionSleep-related psychoeducation will be provided in weekly lesson content. Phone coaching will revolve around sleep health and meeting sleep goals. |
| Healthy Living | Active comparator | Behavioral: Healthy Living PsychoeducationPsychoeducation 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep ExtensionWeekly educational material about sleep health and weekly brief phone coaching calls for a total of 6 weeks. | Behavioural | Sleep Extension |
| Healthy Living PsychoeducationWeekly educational materials about healthy habits and weekly brief phone calls to clarify terms or concepts. | Behavioural | Healthy Living |
Primary outcome
Feasibility
Time frame: 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
Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured by sessions completed
Acceptability
Time frame: At end of 6-week intervention
Acceptability of Intervention Measure
Sleep duration
Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured by Fitbit
Sleep efficiency
Time frame: 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)
Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Measured by Fitbit
Subjective sleep quality
Time frame: 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.
Internalizing symptoms
Time frame: 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.
3 secondary outcomes
Daytime fatigue
Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Bedtime Procrastination
Time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)
Electronics use before bed
Time frame: Pre-treatment and at 6-week post-treatment assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Internalizing Mental Health Symptoms
Recruiting
Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation
Mental Health, Parenting / Maternal Behavior
Not yet recruitingEarly Phase 1
Micropractices for Unhoused LGBTQ Youth
Well-Being (Psychological Flourishing), Internalizing Mental Health Symptoms
Recruiting
Experimental Evidence of the Impact of Parental Income on Child Mental Health and Neuroimmune Function
Psychopathology, Child Mental Health
Recruiting
Students Rising Above: Offsetting the Health and Mental Health Costs of Resilience
Internalizing Mental Health Symptoms, Allostatic Load
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Duffecy, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Extension and Healthy Living Psychoeducation in people with Internalizing Mental Health Symptoms and Sleep Problems, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: From enrollment to the end of post-treatment follow-up period (10 weeks after start of intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.