Sleep Treatment for Teens

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 Overview

• Status: Completed
• Conditions: Suicidal Ideation; Suicide, Attempted; Sleep Problem
• Intervention / Treatment: Other: Sleepio (TM)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • 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

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleepio; Participants will receive the SleepioTM app	Other: Sleepio (TM); Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 10 weeks to match assessment with the TAU only group).	up to 10 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.	up to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep problems	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	Daily reports of suicide ideation from EMA	daily through study completion, up to 10 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Old Dominion University; Children's Hospital of The King's Daughters

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): January 24, 2025
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Self-Injurious Behavior; Sleep Wake Disorders; Suicide; Suicidal Ideation; Dyssomnias; Parasomnias; Suicide, Attempted
• Other Study ID Numbers: Pro2021001233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared in accordance with NIMH Data Archive Agreement
• IPD Sharing Time Frame: 1 year after the study is complete
• IPD Sharing Access Criteria: Registration on NIMH Data Archive
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No