A Double-blind Randomized Controlled Study on Influence of E-aid Cognitive Behavioral Therapy for Insomnia to Reduce Incidence of Depression as Well as Suicidal Ideation in Patients With Insomnia
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- occurrence of depression
研究概览
简要总结
In the past, there were studies on relationship between insomnia and depression, and those studies found that depression can be the result of untreated insomnia. Mostly insomnia precedes depression, and is a marker for recurrence of depression. Research suggests that insomnia may cause depression by changing the emotional response.
In this study, investigators will establish the national online cognitive behavioral therapy for insomnia (e-aid Cognitive Behavioral Therapy for Insomnia, eCBTI ) tools, and online health education on sleep (e-aid Sleep Hygiene Education, eSHE ) tools for controls. Investigators will be testing whether eCBTI can reduce the incidence of depression in patients with sleep disorders, increasing remission rate of depression, and a corresponding reduction in suicidal ideas, compared with eSHE control groups.
详细描述
1000 patients suffering from insomnia will be recruited in this study.Participants with insomnia will be taken from: A. the WeChat platform, B. the customer group of intelligent hardware/software, and C.outpatient department. 1000 participants with insomnia will be randomly divided into eCBTI group and eSHE group equally that each group will have 500 participants.
Participants will be requested to accept online structured questionnaire, including social and demographic data and insomnia disorders diagnosis process (adapted from "A guide to diagnosis and treatment of insomnia in China"). If the interviewee meets the criteria of entry, then participants are requested to fill online informed consent and then enrolled into the baseline assessment.
Baseline assessment includes two parts:
1, Self-reported questionnaire: Insomnia Severity Index, ISI, Dysfunctional Beliefs and Attitudes about Sleep, DBAS, Sleep Hygiene and Practices Scale, SHPS, Pre - Sleep Arousal Scale, PSAS, Epworth Sleepiness Scale, ESS, Hospital Anxiety and Depression Scale, HADS, Short - Form 12 - Item Health Survey, SF - 12; 2. Researcher Interview: Clinical Interview of depression in the Mini International Neuropsychiatric Interview (MINI).
Therapeutic intervention: Both groups will be treated for 4 weeks, and multiple follow-up visits within 12 months.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the diagnostic criteria for insomnia in accordance with DSM-5
- •18 years or older
- •compliant and have a good understanding of research program
- •able to fill the online informed consent form
- •owns and have a good command on electronic gadgets (e.g., smart phones, tablets, computers, etc.)
排除标准
- •clear and unhealed physical, mental and/or sleep disorders requiring acute care
- •is taking psychotherapy for insomnia
- •shift workers, regular night shift workers, frequent time zone fliers (such as crew members on international flights)
研究组 & 干预措施
e-aid Cognitive Behavior Therapy
Participants receive e-aid cognitive behavior therapy. Every week, this group will receive researcher guided individual customized sleep restriction and stimulus control therapy.
干预措施: e-aid Cognitive Behavior Therapy (Behavioral)
e-aid Sleep Hygiene Education
Participants receive e-aid sleep hygiene education which consists of general sleep health education and the guidance on questionnaires. Every week, this group will receive researcher guided sleep hygiene.
干预措施: e-aid Sleep Hygiene Education (Behavioral)
结局指标
主要结局
occurrence of depression
时间窗: changes of occurrence of depression from baseline to 2weeks, 5 weeks, 6 months and 12 months.
Clinical Interview of depression in the Mini-International Neuropsychiatric Interview (MINI) by investigators by telephone or online.
次要结局
- Changes in Insomnia Severity Index(ISI)(changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.)
- Treatment adherence rating scale(changes of scale score from baseline to 6 months and 12 months)
- Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)(changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.)
- occurrence of suicidal ideation(changes of occurrence of suicidal ideation from baseline to 2 weeks, 5 weeks, 6 months and 12 months.)
- Treatment satisfaction rating scale (TSRS)(changes of scale score from baseline to 6 months and 12 months)
- Changes in Hospital Anxiety and Depression Scale (HADS)(changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.)
- Changes in Short - Form 12 - Item Health Survey（SF-12）(changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.)
- Changes in Sleep Hygiene and Practices Scale(SHPS)(changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.)
- Changes in Pre-Sleep Arousal Scale(PSAS)(changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.)
- Changes in Epworth Sleepiness Scale(ESS)(changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.)