NCT05822999已完成不适用
A Multicenter, Randomized, Double-blinded, Sham-controlled Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy for Insomnia
WELT corp2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from baseline (before using) to week 8 (after 6 weeks of using) of Insomnia severity index (ISI)
研究概览
简要总结
The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital therapeutics.
详细描述
This was a randomized, double-blinded, sham-controlled trial. Overall, 52 subjects were randomized into the following groups:
- WELT-IP group: WELT-IP (insomnia digital therapeutics) use
- Control group: sham app use Subjects in both groups continued to receive their clinician-directed standard-of-care treatment for insomnia, if applicable, including pharmacotherapy. Subjects were randomized and in WELT-IP group used WELT-IP and subjects in control group used a sham for a period of 6 weeks.
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 (Participant, Investigator)
盲法说明
double-blinded
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-5 insomnia patient
- •ISI of 8 or above
- •for 7 days before baseline visit (Visit 2), completing sleep diary for more than 4 days in the guidelines
- •capable of using mobile device and application
排除标准
- •currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
- •sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
- •progressive and active medical conditions
- •received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
- •major psychiatric illness as assessed through MINI
- •suicide risk as assessed through C-SSRS
- •having occupational risk due to sleep restriction
- •shift workers
结局指标
主要结局
Change from baseline (before using) to week 8 (after 6 weeks of using) of Insomnia severity index (ISI)
时间窗: 8 weeks
Insomnia severity index has seven questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
次要结局
- Change from baseline (before using) to week 8 (after 6 weeks of using) of Dysfunctional beliefs and attitudes about sleep-16 (DBAS-16)(8 weeks)
- Change from baseline (before using) to week 8 (after 6 weeks of using) of Pittsburgh sleep quality index (PSQI)(8 weeks)
- Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep efficiency (SE)(8 weeks)
- Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep quality (SQ)(8 weeks)
- Change from baseline (before using) to week 14 (after 6 weeks from close out visit) of Insomnia severity index (ISI) for WELT-IP group(14 weeks)
- Change from week 1 (before using) to week 8 (after 6 weeks of using) of Sleep onset latency (SOL)(8 weeks)
- Change from week 1 (before using) to week 8 (after 6 weeks of using) of Wake after sleep onset (WASO)(8 weeks)
- Change from baseline (before using) to week 8 (after 6 weeks of using) of Patient health questionnaire-9 (PHQ-9)(8 weeks)
- Change from baseline (before using) to week 8 (after 6 weeks of using) of Epworth sleepiness scale (ESS)(8 weeks)
- Change from week 1 (before using) to week 8 (after 6 weeks of using) of Total sleep time (TST)(8 weeks)
- Change from week 1 (before using) to week 8 (after 6 weeks of using) of Number of awakening (NOA)(8 weeks)
- Change from baseline (before using) to week 8 (after 6 weeks of using) of Generalized anxiety disorder-7 item scale (GAD-7)(8 weeks)
- Percentage of subjects achieving SE ≥ 85%(8 weeks)
- Compliance (completion rate of lessons, for WELT-IP group only)(8 weeks)
研究者
研究点 (2)
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