Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry: a Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Change from Baseline Insomnia Severity Index- adolescent version (ISI-a)
研究概览
简要总结
The study is a clinical pilot study that examine the preliminary effect of cognitive-behavioral therapy for insomnia (CBT-I) in adolescents with comorbid psychiatric disorders. Participants (n=25) are recruited from three psychiatric clinics (n=19) and one pediatric pain clinic (n=6). After diagnostic assessment, participants that fulfil inclusion criteria are offered the CBT-I intervention. Pre-post and 3-months follow-up assessments include subjective measures of insomnia symptom severity, sleep parameters (collected through sleep-wake diaries), symptoms of depression and anxiety and daytime functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be between 13-17 years old
- •meet criteria for insomnia disorder (primary or secondary insomnia) according to DSM-IV-TR
- •have insomnia symptoms at a clinical level, as defined as more than 10 points on the ISI-a
- •adequate Swedish language skills
排除标准
- •severe psychiatric disorder that is contraindicative of the treatment (i.e., bipolar disorder, psychotic disorder)
- •autistic disorder
- •severe suicidality (defined as ≥17 points on MINI-kid suicide subscale)
- •alcohol or drug dependence
- •psychotropic medication
- •previous (> 5 sessions) or ongoing CBT-treatment for insomnia
研究组 & 干预措施
CBT-I
干预措施: CBT-I (Behavioral)
结局指标
主要结局
Change from Baseline Insomnia Severity Index- adolescent version (ISI-a)
时间窗: 6 weeks and 3 months
The Insomnia Severity Index, ISI -adolescent version18 was used before, after at three months follow-up to measure insomnia symptom severity. ISI-a is an adaptation to adolescents of the Insomnia Severity Index32,36. ISI-a is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity.
次要结局
- Spences' Children Anxiety Scale (SCAS)(Baseline, 6 weeks and 3 months)
- Total Sleep Time (TST)(Baseline, 6 weeks and 3 months)
- Sleep Efficiency (SE)(Baseline, 6 weeks and 3 months)
- Sleep Onset Latency (SOL)(Baseline, 6 weeks and 3 months)
- Wake after sleep onset (WASO)(Baseline, 6 weeks and 3 months)
- Center for Epidemiological Studies Depression Scale for Children (CES-DC)(Baseline, 6 weeks and 3 months)
研究者
Mats Lekander
Professor
Karolinska Institutet