Sleep Treatment for Teens
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Evan Kleiman
- Phone Number: 2153596148
- Email: evan.kleiman@rutgers.edu
Study Locations
-
-
New Jersey
-
Piscataway, New Jersey, United States, 08854
- Rutgers University Behavioral Healthcare
-
-
Virginia
-
Norfolk, Virginia, United States, 23529
- Old Dominion University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Sleepio
Participants will receive the SleepioTM app
|
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insomnia severity
Time Frame: up to 10 weeks
|
Insomnia Severity Index (same measure as baseline) assessed weekly from the beginning of treatment until the treatment is complete (or a maximum of 10 weeks to match assessment with the TAU only group).
|
up to 10 weeks
|
|
Suicidal thoughts
Time Frame: up to 10 weeks
|
Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.
|
up to 10 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep problems
Time Frame: daily through study completion, up to 10 weeks
|
The following sleep parameters will be assessed using a combination of daily sleep diaries (EMA app) and wrist actigraphy (Actiwatch).
(a) sleep efficiency (SE): % of time in bed spent asleep; (b) sleep onset latency (SOL): how many minutes it takes to fall asleep; (c) total sleep time (TST): actual time slept (out of time in bed); (d) wake after sleep onset (WASO): total amount of time awake during the night; and (e) sleep quality: subjective ratings on 1=very poor to 5=very good.
|
daily through study completion, up to 10 weeks
|
|
Daily Suicidal Thoughts
Time Frame: daily through study completion, up to 10 weeks
|
Daily reports of suicide ideation from EMA
|
daily through study completion, up to 10 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Pro2021001233
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicidal Ideation
-
NCT07365579Not yet recruitingSuicidal Ideation and Behavior
-
NCT07343258RecruitingSuicide | Suicidal Ideation and Behavior | Crisis Intervention
-
NCT07321171RecruitingSuicidal Ideation and Behavior
-
NCT01829620CompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
NCT01300169CompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
NCT02691221CompletedSuicide, Suicidal Ideation
-
NCT01359761UnknownSuicide, Attempted | Suicidal Ideation Active
-
NCT07559955RecruitingSuicidal Ideation and Behavior
-
NCT06885047Not yet recruitingSuicidal Ideation/Behavior
-
NCT06686498Active, not recruitingSuicidal Ideation | Suicidal Ideation and Behaviors
Clinical Trials on Sleepio (TM)
-
NCT05050201RecruitingInsomnia | Psychosis | First Episode Psychosis
-
NCT04180709CompletedPsychotic Disorders | Sleep | Psychosis
-
NCT05511285Recruiting
-
NCT05962138Completed
-
NCT05596318Active, not recruitingDepression | Insomnia
-
NCT07303959RecruitingSuicidal Ideation | Suicidal Behavior | Sleep Problems
-
NCT05816304RecruitingDepression | Anxiety Disorders | Insomnia | Post Traumatic Stress Disorder
-
NCT05568381CompletedSleep Wake Disorders | Insomnia | Cognitive Dysfunction | Mild Cognitive Impairment | Cognitive Disorder
-
NCT02571595TerminatedInsomnia Disorder | HIV - Human Immunodeficiency Virus