CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Improvement in depression and current severity of depression
研究概览
简要总结
This study is a randomized controlled trial that tests the effectiveness of cognitive behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who have recently begun selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is compared with a control condition of sleep hygiene education.
详细描述
160 youth with depression and comorbid insomnia who have just initiated a course of SSRI antidepressants will be randomized to insomnia-focused cognitive behavior therapy (CBT-I) or an attention control condition of sleep hygiene (SH) education. All participants will have in-person treatment sessions and will complete sleep diaries and wear an actigraph to record activity levels. Participants will be followed for 12 months.
Primary depression outcomes are score on the Clinical Global Impressions Improvement (CGI-I) and major depressive disorder diagnostic remission; primary sleep outcomes are actigraphy total sleep time and score on the Insomnia Severity Index (ISI). Secondary outcomes include additional sleep and depression outcomes. The study will also include economic analyses.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 19
- •Major depression based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- •Recent dispense of SSRI antidepressant
- •Subjective complaint of insomnia ≥ one month
- •Score of ≥ 9 on Insomnia Severity Index
排除标准
- •Active, progressive physical illness or neurological degenerative disease
- •Sleep apnea, restless legs, or limb movements during sleep
- •Diagnosis of delayed sleep phase syndrome (DSPS)
- •Mental retardation, autism spectrum disorder (ASD), or other significant pervasive developmental disability (PDD)
- •Sleep treatments including over-the-counter (OTC) sleep medication or CBT for insomnia
- •Medications known to alter sleep
- •Diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
结局指标
主要结局
Improvement in depression and current severity of depression
时间窗: 52 weeks from baseline
Improvement in depression is measured by the Clinical Global Impression-Improvement (CGI-I), and severity is measured by the Clinical Global Impression-Severity (CGI-S).
Psychiatric Status Ratings (PSRs) for major depressive disorder (MDD)
时间窗: 52 weeks from baseline
PSRs will be measured using the Children's Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and Longitudinal and Interval Follow-up Evaluation (LIFE).
Increase in total sleep time across the study period
时间窗: 52 weeks from baseline
Total sleep time is calculated from a sleep diary, which participants complete for 2 weeks following each assessment and during active sleep treatment, and from ActiGraph devices, which measure total sleep time and physical activity 24 hours per day during active sleep treatment and for 2 weeks following each assessment.
Severity of insomnia based on ISI
时间窗: 52 weeks from baseline
Insomnia severity is measured by the Insomnia Severity Index (ISI)
次要结局
- Severity of depression based on CDRS-R and PHQ-9(52 weeks from baseline)