Sleep Treatment for Teens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Insomnia severity
研究概览
简要总结
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. 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=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011). Regarding recency, adolescents will need to complete the baseline within three months (Study 1) or 45 days (Study 2) of discharge in order to capture the high-risk post-discharge period, which is up to 3 months following discharge from acute psychiatric hospitalization (Chung et al., 2017).
- •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 of adolescents' sleep problems in order to confirm primary insomnia. ISI scores may also be obtained via chart review when applicable
- •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 later. Metricwire is compatible with all devices that SleepioTM is compatible with. If an interested adolescent does not have access to their own smart device, the research team will offer them a loaner device for the duration of the treatment/follow-up phase.
- •Adolescents will be excluded based on the following
排除标准
- •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, race, or ethnicity. These variables will be assessed during screening to compare those who are and are not eligible.
- •Having a sibling who has enrolled in the study.
研究组 & 干预措施
Sleepio (TM) + Treatment as usual (TAU) + EMA
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
干预措施: Treatment as Usual (TAU) (Behavioral)
Treatment as usual (TAU) + ecological momentary assessment (EMA)
Treatment as usual plus assessments via EMA
干预措施: Treatment as Usual (TAU) (Behavioral)
Sleepio (TM) + Treatment as usual (TAU) + EMA
Sleepio is a mobile Digital Cognitive Behavior Therapy for Insomnia (dCBT-I) app.
干预措施: Sleepio (Behavioral)
结局指标
主要结局
Insomnia severity
时间窗: Up to 12 weeks
Insomnia Severity Index (same measure as baseline) assessed weekly from the beginning of treatment until the treatment is complete (or a maximum of 12 weeks to match assessment with the TAU group).
Suicidal thoughts
时间窗: Up to 12 weeks
Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.
Insomnia severity
时间窗: Up to 12 weeks
Insomnia Severity Index (same measure as baseline) assessed weekly from the beginning of treatment until the treatment is complete (or a maximum of 12 weeks to match assessment with the TAU group).
Suicidal thoughts
时间窗: Up to 12 weeks
Suicide ideation severity will be measured weekly with the Beck Suicide Ideation Scale (same measure as baseline) until the end of treatment.
次要结局
- Sleep efficiency(Daily through study completion, up to 12 weeks)
- Sleep Onset Latency(Daily throughout the study (12 weeks))
- Daily Suicidal Thoughts(Daily through study completion, up to 12 weeks)
- Wake after sleep onset(Daily through study completion, up to 12 weeks)
- Subjective sleep quality(Daily through study completion, up to 12 weeks)
- Sleep efficiency(Daily through study completion, up to 12 weeks)
- Sleep Onset Latency(Daily throughout the study (12 weeks))
- Daily Suicidal Thoughts(Daily through study completion, up to 12 weeks)
- Wake after sleep onset(Daily through study completion, up to 12 weeks)
- Subjective sleep quality(Daily through study completion, up to 12 weeks)
研究者
Evan M. Kleiman, Ph.D.
Associate Professor
Rutgers, The State University of New Jersey