Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide: A Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The proposed research addresses the urgent need to reduce suicide rates among teens. This will be the first study that the investigators know of that will examine the feasibility and preliminary effectiveness of augmenting a suicide-focused treatment (Dialectical Behavior Therapy, [DBT]) with an evidence-based treatment protocol for insomnia (a digital version of Cognitive Behavioral Therapy for Insomnia [CBT-I]). The goal of this clinical trial is to learn providing insomnia treatment in conjunction with suicide-focused treatment leads to greater reductions in suicidality and self-harm than suicide-focused treatment alone.
Participants will be randomly assigned to receive 6 months of DBT plus CBT-I or to DBT alone and will complete research assessments measuring suicidal ideation, self-harm behavior and insomnia symptoms every four weeks over the course of the study, as well as one post-treatment follow-up assessment. Participants will also wear a device on their wrist (like a Fitbit or wristwatch) for 10 days following each assessment to collect data about their sleep.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12-18 years of age and not yet graduated from high school.
- •Insomnia symptoms, defined as a total score of ≥ 8 on the Insomnia Severity Index .
- •High suicide risk, defined as: > 3 lifetime self-harm episodes (with at least 1 in the 12 weeks before baseline screening) and elevated suicidal ideation (≥31 on the SIQ-Jr.).
- •If taking medication for psychiatric disorders or sleep, must be on a stable dose (>2 months).
- •Youth and parent both speak English.
- •At least one family member or responsible adult agrees to participate in assessments and in the DBT multi-family skills group.
- •Youth lives at home.
排除标准
- •Significant current mania or psychosis; life threatening anorexia, or other diagnosis of a severe mental or physical condition requiring treatment specific to that disorder and/or that interferes with participation in assessments or treatment.
- •A history of being diagnosed with an Autism Spectrum Disorder.
- •Has a comorbid untreated sleep apnea or a severe circadian sleep-wake disorder with a habitual bedtime after 3 AM or habitual rise time after 11 AM.
- •Insomnia symptoms are significantly impacted by substance use or withdrawal of psychoactive medications.
- •Has conditions that require caution when implementing CBTI, such as bipolar and seizure disorders.
- •Court-ordered to treatment.
研究组 & 干预措施
Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia
干预措施: Dialectical Behavior Therapy (Behavioral)
Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Dialectical Behavior Therapy Only
干预措施: Dialectical Behavior Therapy (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
The ISI (Morin, 1993) is a 7-item self-report questionnaire that measures insomnia symptoms on a 4-point scale. Total score ranges from 0-28, with a total score of \> 9 being validated as the optimal cutoff for a likely insomnia diagnosis.
Suicidal Ideation Questionnaire Junior (SIQ-JR)
时间窗: Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
The SIQ-JR (Reynolds 1987) is a 15-item self-report questionnaire that assesses suicidal thoughts on a 7-point scale (I never had this thought to almost every day). Scores range from 0 to 90, with a published clinical cut-off score of 31.
Suicide Attempt Self-Injury Interview and Count
时间窗: Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
Structured clinical interview that measures number, dates, method, intent and lethality of suicide attempts and non-suicidal self-injury episodes.
次要结局
未报告次要终点
研究者
Michele Berk
Assistant Professor
Stanford University