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Sleep Treatment for Teens

Primary Purpose

Sleep Problem, Suicidal Ideation, Suicide, Attempted

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleepio (TM)
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Problem

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rutgers University Behavioral Healthcare
  • Old Dominion UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleepio

Arm Description

Participants will receive the SleepioTM app

Outcomes

Primary Outcome Measures

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).
Suicidal thoughts
Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.

Secondary Outcome Measures

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 Suicidal Thoughts
Daily reports of suicide ideation from EMA

Full Information

First Posted
May 19, 2022
Last Updated
August 7, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Old Dominion University, Children's Hospital of The King's Daughters
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1. Study Identification

Unique Protocol Identification Number
NCT05397353
Brief Title
Sleep Treatment for Teens
Official Title
Sleep Treatment for Teens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Old Dominion University, Children's Hospital of The King's Daughters

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problem, Suicidal Ideation, Suicide, Attempted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleepio
Arm Type
Experimental
Arm Description
Participants will receive the SleepioTM app
Intervention Type
Other
Intervention Name(s)
Sleepio (TM)
Intervention Description
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
Primary Outcome Measure Information:
Title
Insomnia severity
Description
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).
Time Frame
up to 10 weeks
Title
Suicidal thoughts
Description
Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.
Time Frame
up to 10 weeks
Secondary Outcome Measure Information:
Title
Sleep problems
Description
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.
Time Frame
daily through study completion, up to 10 weeks
Title
Daily Suicidal Thoughts
Description
Daily reports of suicide ideation from EMA
Time Frame
daily through study completion, up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evan Kleiman
Phone
2153596148
Email
evan.kleiman@rutgers.edu
Facility Information:
Facility Name
Rutgers University Behavioral Healthcare
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Kleiman
Email
evan.kleiman@rutgers.edu
First Name & Middle Initial & Last Name & Degree
Evan Kleiman
Facility Name
Old Dominion University
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23529
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Glenn
Phone
757-683-4439
Email
cglenn@odu.edu
First Name & Middle Initial & Last Name & Degree
Catherine Glenn, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Sleep Treatment for Teens

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