Sleep ProblemNCT05397353
Sleep Treatment for Teens
A study testing Sleepio (TM) in people with Sleep Problem 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 test 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… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Sleep Problem, Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Sleepio (TM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Feb 2023to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 (assessed via review of unit census).
- Recent psychiatric hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan): assessed using an abbreviated version of the Columbia Suicide Severity Rating Scale (C-SSRS). In terms of recency, adolescents will need to enroll in the baseline assessment within three months of discharge from the hospital in order to assess the high-risk post-hospitalization period.
- Clinically significant insomnia symptoms: consistent with prior trials using the SleepioTM package, participants will be screened using the Sleep Condition Indicator (SCI)-an 8-item measure created by SleepioTM treatment developers to screen for DSM-5 insomnia disorder. The SCI assesses sleep duration, quality, and difficulties, and daytime impairment due to sleep problems; lower scores on the SCI indicate poorer sleep conditions and a cutoff of ≤16 indicates probable insomnia disorder, which will be the cutoff used for the current study.
- Motivation to engage in sleep treatment: consistent with other trials testing SleepioTM, questions will be used to assess perception of sleep problem severity and desire to change. The scale includes (1) "At present, sleep is a big problem for me" and (2) "I want to change my sleep" rated on a scale 0=strongly disagree to 10=strongly agree. Each item must be rated ≥5, in line with prior trials. Given this is a digital intervention, this criterion will help ensure we recruit adolescents who are likely to engage with treatment. Importantly, we note that prior trials have not needed to exclude anyone based on this criterion, reflecting the idea that the majority of participants we encounter will be motivated to engage in this novel treatment.
Who cannot join
- Prior CBT-I treatment (the intervention being tested in this study): prior treatment would indicate non-response to a reasonable dose of this empirically supported treatment.
- At high risk for obstructive sleep apnea (OSA): The STOP-BANG sleep apnea screening questionnaire (modified for adolescents) will be used to screen adolescents at high risk for OSA, who will be referred for a non-study polysomnography screening.
- Bipolar disorder: given concerns that certain components of CBT-I (i.e., sleep restriction) may be risky for this population.
- Substance use disorder that is primary to insomnia: significant substance use (alcohol or drug) disorders would require alternative treatment.
- Presence of factors that may reduce participant's ability to provide assent/consent or to complete the study procedures (e.g., non-English speaking, severe cognitive impairment, pervasive developmental disorder, acute psychosis, risk for other-directed violence).
- Unwillingness to wear the actigraphy device or to complete smartphone-based EMA at the time of enrollment: consistent with the research team's prior studies, if participants are actively enrolled in the study and then decide that they no longer want to wear the wrist actigraphy device, we will give them the option to continue only the SleepioTM and smartphone-based EMA parts of the study. • Not having a parent/legal guardian willing to provide permission (if adolescent is a minor) or consent (for their own participation): although permission is only required for minors, parents will be included for all adolescents to keep study procedures consistent for all participants.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Old Dominion University
Norfolk, Virginia, 23529
Rutgers University Behavioral Healthcare
Piscataway, New Jersey, 08854
About this study
The purpose of this research study is to test 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=20 pilot, 50% at each site), will receive dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU). 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 Problem, Suicidal Ideation, Suicide, Attempted
- Being tested
- Sleepio (TM)
- Medical subject headings
- Parasomnias, Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleepio (TM)Other
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
| Study group | Role | What they receive |
|---|---|---|
| Sleepio | Experimental | Participants will receive the SleepioTM app Receives: Other: Sleepio (TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity
Insomnia Severity Index (ISI), a 7-item self-report measure of insomnia symptom severity. Total scores are calculated by summing the seven items and range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). The ISI was assessed weekly throughout treatment; results presented here are baseline and end-of-study scores.
Measured: Baseline and end of study (up to 10 weeks after baseline).
Suicidal Thoughts
Suicide Ideation Questionnaire Junior, a self-report measure of suicidal ideation. Total scores range from 0 to 90, with higher scores indicating greater suicidal ideation (worse outcome).
Measured: Baseline and end of study (up to 10 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start10 Feb 2023
- Primary completion24 Jan 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep ProblemStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397353
- Sponsor's protocol ID
- Pro2021001233
- Status last verified
- Jun 2026
- First submitted
- 19 May 2022
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in accordance with NIMH Data Archive Agreement
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Treatment for Teens
- ClinicalTrials.gov ID
- NCT05397353
- Acronym / sponsor ID
- Pro2021001233
- Conditions
- Sleep Problem, Suicidal Ideation, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Old Dominion University, Children's Hospital of The King's Daughters
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Posted 8 Jul 2026
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 test 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=20 pilot, 50% at each site), will receive dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU). 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleepio | Experimental | Other: Sleepio (TM)Participants will receive the SleepioTM app |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 14-18 years old (assessed via review of unit census).
- Recent psychiatric hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan): assessed using an abbreviated version of the Columbia Suicide Severity Rating Scale (C-SSRS). In terms of recency, adolescents will need to enroll in the baseline assessment within three months of discharge from the hospital in order to assess the high-risk post-hospitalization period.
- Clinically significant insomnia symptoms: consistent with prior trials using the SleepioTM package, participants will be screened using the Sleep Condition Indicator (SCI)-an 8-item measure created by SleepioTM treatment developers to screen for DSM-5 insomnia disorder. The SCI assesses sleep duration, quality, and difficulties, and daytime impairment due to sleep problems; lower scores on the SCI indicate poorer sleep conditions and a cutoff of ≤16 indicates probable insomnia disorder, which will be the cutoff used for the current study.
- Motivation to engage in sleep treatment: consistent with other trials testing SleepioTM, questions will be used to assess perception of sleep problem severity and desire to change. The scale includes (1) "At present, sleep is a big problem for me" and (2) "I want to change my sleep" rated on a scale 0=strongly disagree to 10=strongly agree. Each item must be rated ≥5, in line with prior trials. Given this is a digital intervention, this criterion will help ensure we recruit adolescents who are likely to engage with treatment. Importantly, we note that prior trials have not needed to exclude anyone based on this criterion, reflecting the idea that the majority of participants we encounter will be motivated to engage in this novel treatment.
Key exclusion criteria (6 listed)
- Prior CBT-I treatment (the intervention being tested in this study): prior treatment would indicate non-response to a reasonable dose of this empirically supported treatment.
- At high risk for obstructive sleep apnea (OSA): The STOP-BANG sleep apnea screening questionnaire (modified for adolescents) will be used to screen adolescents at high risk for OSA, who will be referred for a non-study polysomnography screening.
- Bipolar disorder: given concerns that certain components of CBT-I (i.e., sleep restriction) may be risky for this population.
- Substance use disorder that is primary to insomnia: significant substance use (alcohol or drug) disorders would require alternative treatment.
- Presence of factors that may reduce participant's ability to provide assent/consent or to complete the study procedures (e.g., non-English speaking, severe cognitive impairment, pervasive developmental disorder, acute psychosis, risk for other-directed violence).
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 |
|---|---|---|
| Sleepio (TM)Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app. | Other | Sleepio |
Primary outcome
Insomnia Severity
Time frame: Baseline and end of study (up to 10 weeks after baseline).
Insomnia Severity Index (ISI), a 7-item self-report measure of insomnia symptom severity. Total scores are calculated by summing the seven items and range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). The ISI was assessed weekly throughout treatment; results presented here are baseline and end-of-study scores.
Suicidal Thoughts
Time frame: Baseline and end of study (up to 10 weeks after baseline).
Suicide Ideation Questionnaire Junior, a self-report measure of suicidal ideation. Total scores range from 0 to 90, with higher scores indicating greater suicidal ideation (worse outcome).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared in accordance with NIMH Data Archive Agreement
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (TM) in people with Sleep Problem 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 4 inclusion and 6 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 8 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?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insomnia Severity (time frame: Baseline and end of study (up to 10 weeks after baseline).). 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 8 Jul 2026.