Sleep ProblemsNCT07303959
Sleep Treatment for Teens (RCT Phase)
A study testing Sleepio and Treatment as Usual (TAU) in people with Sleep Problems and Suicidal Ideation, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
The purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Sleep Problems, Suicidal Ideation, Suicidal Behavior
- What is being tested?
- Sleepio and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14-18 years old.
- Recent hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan) using an abbreviated version of the semi-structured and well-validated Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011). Regarding recency, adolescents will need to complete the baseline within three months (Study 1) or 45 days (Study 2) of discharge in order to capture the high-risk post-discharge period, which is up to 3 months following discharge from acute psychiatric hospitalization (Chung et al., 2017).
- Clinically significant insomnia symptoms: SCI scores ≤16 will be used to recruit a sample with clinically significant insomnia symptoms. The ISI will also be administered to gain additional information about the nature of adolescents' sleep problems in order to confirm primary insomnia. ISI scores may also be obtained via chart review when applicable
- Access to or willingness to use a compatible Smart Device. SleepioTM works with any internet connection (cellular or Wifi) on any iOS device running iOS 10.3 or later or on any Android device running Android OS 8.0 or later. Metricwire is compatible with all devices that SleepioTM is compatible with. If an interested adolescent does not have access to their own smart device, the research team will offer them a loaner device for the duration of the treatment/follow-up phase.
- Adolescents will be excluded based on the following exclusion criteria:
- Prior CBT-I treatment, which would indicate lack of response to a prior reasonable dose of this treatment.
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- Bipolar disorder given that certain components of CBT-I (e.g., sleep restriction) may be risky for this population.
- Substance use disorder that is primary to insomnia which would require alternative treatment.
- Presence of factors that may reduce participants' ability to consent or complete the study procedures (e.g., current psychosis, other-directed violence; severe cognitive impairment, non-English speaking).
- Unwillingness to wear wrist actigraphy or complete the EMA surveys.
- Not having a parent willing to provide permission (if participant is a minor) or to consent to their own participation (required for all adolescents). Eligibility will not be based on biological sex, gender identity, race, or ethnicity. These variables will be assessed during screening to compare those who are and are not eligible.
- Having a sibling who has enrolled in the study.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Catherine Glenn, (757) 683-4458, cglenn@odu.edu
- Recruiting
Rutgers University Behavioral Healthcare
Piscataway, New Jersey, 08854
Evan Kleiman, 2153596148, evan.kleiman@rutgers.edu
About this study
Official title: Sleep Treatment for Teens
The purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.
- Conditions
- Sleep Problems, Suicidal Ideation, Suicidal Behavior
- Being tested
- Sleepio, Treatment as Usual (TAU)
- Medical subject headings
- Parasomnias, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepioBehavioural
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
Treatment as Usual (TAU)Behavioural
Treatment as usual as part of standard inpatient care, and any outpatient care received.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) + ecological momentary assessment (EMA) | Active comparator | Treatment as usual plus assessments via EMA Receives: Behavioral: Treatment as Usual (TAU) |
| Sleepio (TM) + Treatment as usual (TAU) + EMA | Experimental | Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. Receives: Behavioral: Sleepio; Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity
Insomnia Severity Index (same measure as baseline) assessed weekly from the beginning of treatment until the treatment is complete (or a maximum of 12 weeks to match assessment with the TAU group).
Measured: Up to 12 weeks
Suicidal thoughts
Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.
Measured: Up to 12 weeks
Secondary outcomes (5)
Sleep efficiency
Sleep efficiency (SE), percent of time in bed spent asleep, assessed via Actiwatch.
Measured: Daily through study completion, up to 12 weeks
Sleep Onset Latency
Sleep onset latency (SOL): how many minutes it takes to fall asleep, assessed via Actiwatch device
Measured: Daily throughout the study (12 weeks)
Daily Suicidal Thoughts
Daily reports of suicide ideation from EMA
Measured: Daily through study completion, up to 12 weeks
Wake after sleep onset
Wake after sleep onset (WASO): total amount of time awake during the night, assessed via Actiwatch wearable.
Measured: Daily through study completion, up to 12 weeks
Subjective sleep quality
Sleep quality: subjective ratings on 1=very poor to 5=very good, assessed via ecological momentary assessment.
Measured: Daily through study completion, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start2 Jun 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Old Dominion University, Children's Hospital of The King's Daughters
- Responsible party
- Principal investigator, Evan M. Kleiman, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Evan Kleiman, Principal investigator, Rutgers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303959
- Sponsor's protocol ID
- Pro2021001233_mod 10
- Other IDs
- R34MH123590
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Via NIMH data archive
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Treatment for Teens
- ClinicalTrials.gov ID
- NCT07303959
- Acronym / sponsor ID
- Pro2021001233_mod 10
- Conditions
- Sleep Problems, Suicidal Ideation, Suicidal Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Old Dominion University, Children's Hospital of The King's Daughters
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Dec 2025 (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 purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) + ecological momentary assessment (EMA) | Active comparator | Behavioral: Treatment as Usual (TAU)Treatment as usual plus assessments via EMA |
| Sleepio (TM) + Treatment as usual (TAU) + EMA | Experimental | Behavioral: Sleepio, Behavioral: Treatment as Usual (TAU)Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Age 14-18 years old.
- Recent hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan) using an abbreviated version of the semi-structured and well-validated Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011). Regarding recency, adolescents will need to complete the baseline within three months (Study 1) or 45 days (Study 2) of discharge in order to capture the high-risk post-discharge period, which is up to 3 months following discharge from acute psychiatric hospitalization (Chung et al., 2017).
- Clinically significant insomnia symptoms: SCI scores ≤16 will be used to recruit a sample with clinically significant insomnia symptoms. The ISI will also be administered to gain additional information about the nature of adolescents' sleep problems in order to confirm primary insomnia. ISI scores may also be obtained via chart review when applicable
- Access to or willingness to use a compatible Smart Device. SleepioTM works with any internet connection (cellular or Wifi) on any iOS device running iOS 10.3 or later or on any Android device running Android OS 8.0 or later. Metricwire is compatible with all devices that SleepioTM is compatible with. If an interested adolescent does not have access to their own smart device, the research team will offer them a loaner device for the duration of the treatment/follow-up phase.
- Prior CBT-I treatment, which would indicate lack of response to a prior reasonable dose of this treatment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SleepioSleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. | Behavioural | Sleepio (TM) + Treatment as usual (TAU) + EMA |
| Treatment as Usual (TAU)Treatment as usual as part of standard inpatient care, and any outpatient care received. | Behavioural | Sleepio (TM) + Treatment as usual (TAU) + EMA, Treatment as usual (TAU) + ecological momentary assessment (EMA) |
Primary outcome
Insomnia severity
Time frame: Up to 12 weeks
Insomnia Severity Index (same measure as baseline) assessed weekly from the beginning of treatment until the treatment is complete (or a maximum of 12 weeks to match assessment with the TAU group).
Suicidal thoughts
Time frame: Up to 12 weeks
Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.
5 secondary outcomes
Sleep efficiency
Time frame: Daily through study completion, up to 12 weeks
Sleep Onset Latency
Time frame: Daily throughout the study (12 weeks)
Daily Suicidal Thoughts
Time frame: Daily through study completion, up to 12 weeks
Wake after sleep onset
Time frame: Daily through study completion, up to 12 weeks
Subjective sleep quality
Time frame: Daily through study completion, up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. Via NIMH data archive
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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.
Evan Kleiman principal investigator
Rutgers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleepio and Treatment as Usual (TAU) in people with Sleep Problems and Suicidal Ideation, run by Rutgers, The State University of New Jersey at 2 sites 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 12 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan Kleiman, PhD (848-445-2345, evan.kleiman@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: Up to 12 weeks). The study lists 2 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 10 Jul 2026.