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New treatment option for Sleep Problems
Official title Sleep Treatment for Teens (RCT Phase)
ClinicalTrials.gov ID: NCT07303959
What this study is testing
- What it's testing
- The purpose of this research study is to compare (vs. treatment as usual) 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 18
You may be able to join if
- Inclusion:
- Age 14-18 years old.
- Recent hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan)...
- Clinically significant insomnia symptoms: SCI scores ≤16 will be used to recruit a sample with clinically significant insomnia symptoms. The ISI will...
- Access to or willingness to use a compatible Smart Device. SleepioTM works with any internet connection (cellular or Wifi) on any iOS device running...
You likely can't join if
- Prior CBT-I treatment, which would indicate lack of response to a prior reasonable dose of this treatment.
- Bipolar disorder given that certain components of CBT-I (e.g., sleep restriction) may be risky for this population.
- Substance use disorder that is primary to insomnia which would require alternative treatment.
- Presence of factors that may reduce participants' ability to consent or complete the study procedures (e.g., current psychosis, other-directed...
- Unwillingness to wear wrist actigraphy or complete the EMA surveys.
- Not having a parent willing to provide permission (if participant is a minor) or to consent to their own participation (required for all...
See the full eligibility criteria
- Inclusion:
- Age 14-18 years old.
- Recent hospitalization due to suicide risk (i.e., suicide attempts, aborted/interrupted attempts, or suicide ideation with intent and/or a plan) using an abbreviated version of the semi-structured and well-validated...
- Clinically significant insomnia symptoms: SCI scores ≤16 will be used to recruit a sample with clinically significant insomnia symptoms. The ISI will also be administered to gain additional information about the nature...
- Access to or willingness to use a compatible Smart Device. SleepioTM works with any internet connection (cellular or Wifi) on any iOS device running iOS 10.3 or later or on any Android device running Android OS 8.0 or...
- Prior CBT-I treatment, which would indicate lack of response to a prior reasonable dose of this treatment.
- Bipolar disorder given that certain components of CBT-I (e.g., sleep restriction) may be risky for this population.
- Substance use disorder that is primary to insomnia which would require alternative treatment.
- Presence of factors that may reduce participants' ability to consent or complete the study procedures (e.g., current psychosis, other-directed violence; severe cognitive impairment, non-English speaking).
- Unwillingness to wear wrist actigraphy or complete the EMA surveys.
- Not having a parent willing to provide permission (if participant is a minor) or to consent to their own participation (required for all adolescents). Eligibility will not be based on biological sex, gender identity...
- Having a sibling who has enrolled in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Piscataway, New Jersey, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Piscataway, New Jersey, United States; Norfolk, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.