Sleep Treatment for Teens

Suicidal Ideation Clinical Trial

Official title:

Sleep Treatment for Teens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397353
• Other study ID #: Pro2021001233
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Evan Kleiman
• Phone: 2153596148
• Email: evan.kleiman[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Problem
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Other:
• Sleepio (TM)
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.

Locations

Country	Name	City	State
United States	Old Dominion University	Norfolk	Virginia
United States	Rutgers University Behavioral Healthcare	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Children's Hospital of The King's Daughters, Old Dominion University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Daily Suicidal Thoughts	Daily reports of suicide ideation from EMA	daily through study completion, up to 10 weeks